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510(k) Data Aggregation
(195 days)
Midmark Corporation
The Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.
The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization.
The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber.
The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes.
The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle.
All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.
The provided document is a 510(k) summary for the Midmark Smart M9® and Smart M11® Sterilizers. It details the device's characteristics and its non-clinical performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on its ability to perform sterilization effectively and safely according to established standards. The reported device performance is indicated by its compliance with these standards.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Used) | Reported Device Performance (Results) |
|---|---|
| Performance: ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers (FDA Recognition Number 14-518) | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| Safety: ANSI/UL 61010-1 Third Edition 5/12/2012 / Revised 7/19/2019, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements (FDA Recognition Number 19-41) | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| Safety: IEC 61010-2-040:2020 Edition 3.0 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| EMC (Electromagnetic Compatibility): IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA Recognition Number 19-36) | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
| Pressure Vessel: American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section VIII, Division 1: 2023 Edition | Passed; the results of the evaluation demonstrate compliance of the device to the standards. |
Study Details:
The document states that non-clinical evaluations were performed for the Midmark Smart M9® and Smart M11® Sterilizer. The purpose of these evaluations was to demonstrate compliance with recognized standards for safety and performance, thereby proving substantial equivalence to a legally marketed predicate device.
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the test set (e.g., number of sterilization cycles tested, number of units tested).
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it concerns a medical device seeking FDA clearance, it's implied that the testing was conducted under controlled conditions to regulatory standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The ground truth for a sterilizer is established through physical and biological indicators demonstrating the elimination of microorganisms, not through expert consensus on image interpretation or diagnosis. The "experts" implicit in this context are the testing laboratories and their personnel following the specified scientific and engineering standards.
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Adjudication method for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For device performance testing against engineering standards, the results are objective measurements (e.g., temperature, pressure, biological indicator kill) that either pass or fail the predefined criteria.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI/CAD systems that assist human readers. The Midmark Smart M9® and Smart M11® Sterilizers are steam sterilizers, and their performance is evaluated directly against physical, chemical, and biological sterilization parameters, not through human interpretation of cases.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the conventional sense of AI/algorithm performance. The device is a physical sterilizer with automated cycles. Its "performance" is inherently "standalone" in that it performs its function without human intervention during the sterilization cycle once initiated. The evaluations listed are standalone device performance tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for a sterilizer's performance is objectively defined by the complete kill of specific biological indicators (e.g., bacterial spores known to be highly resistant to sterilization processes) under specified conditions (temperature, pressure, time). It also includes measured physical parameters (e.g., temperature and pressure profiles over time) matching the standards, and the successful completion of cycles without errors. This is a scientific and engineering ground truth, not based on human consensus or pathology from patient outcomes.
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The sample size for the training set:
- The document does not mention a "training set" in the context of machine learning or AI. This device is a traditional medical device (steam sterilizer), not a deep learning or AI-based diagnostic tool that requires a training set. The design and validation of the sterilizer are based on established engineering principles and extensive physical and biological testing.
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How the ground truth for the training set was established:
- This question is not applicable as there is no mention of a training set for an AI/ML algorithm.
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(48 days)
Midmark Corporation
The intended use of the Midmark EOIS is to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation. When the system is equipped with the CBCT option, the system will also provide volumetric and tomographic images of the oral and maxillofacial region, for diagnostic examination of teeth, jaws, oral structures, and some cranial bones.
The Midmark Extraoral Imaging System (EOIS) is a diagnostic X-ray system using an extraoral source intended for dental radiographic examination and diagnosis of diseases for the following regions of the patient's anatomy:
- . dental (teeth)
- . oral and maxillofacial region (mouth and jaw)
It produces the following radiographic images: - . Panoramic (PAN) images used for diagnostic examination of dentition (teeth), jaws and oral structures.
- Cephalometric (CEPH) images of maxillofacial region and parts of the skull for CEPH examination, if equipped with the CEPH feature.
- . Carpal images assisting in estimating bone-age, if equipped with the CEPH feature, and when the carpal attachment is used.
- . Cone Beam Computed Tomography (CBCT) volumetric and tomographic images of the oral and maxillofacial region for diagnostic examination of dentition (teeth), jaws, oral structures, and some cranial bones, if equipped with the CBCT small or medium feature.
The main modality is limited to PAN radiographic images but can be upgraded by installing the CEPH imaging feature, allowing the device to provide CEPH radiographic images for use in orthodontic treatment planning and evaluation. This extension is also intended to allow carpal imaging to assist in estimating bone-age.
The Midmark EOIS can be upgraded by installing a 3D option allowing the device to produce computed volumetric and tomographic images of the listed above anatomy regions by computed tomographic reconstruction of the digital X-ray data. The X-ray data is captured by two dimensional images taken by exposing the patient anatomy at different anales with a cone shaped X-ray beam. Reconstruction software converts these two-dimensional images into a three-dimensional data set.
The provided text focuses on the K201667 510(k) submission for the Midmark Extraoral Imaging System (EOIS), detailing its indications for use, technological characteristics, and non-clinical performance data.
However, it does not contain detailed information about acceptance criteria for an AI device, nor does it describe a study that explicitly proves an AI device meets such criteria. The document describes a traditional medical imaging device (X-ray system) and its performance, not an AI/ML medical device.
Therefore, I cannot extract the specific information requested in the prompt regarding AI device acceptance criteria and study details. The document describes:
- Non-clinical Performance Data (Section 5.6): This includes medical electrical safety testing, imaging performance testing (against IEC 61223-3-4), dose comparison evaluation, and CBCT modality testing.
- Clinical Performance Data (Section 5.7): This mentions an "Image Performance study" (evaluating image quality of phantom images by dental practitioners for diagnostic acceptability) and a "Usability study" (examining use-related hazards with simulated use involving clinicians).
None of these describe an AI study with its specific acceptance criteria as detailed in the prompt's numbered requests. The "Reconstruction Engines" and "iterative reconstruction" mentioned in Section 5.4 are image reconstruction algorithms, not AI algorithms designed for diagnosis or specific clinical tasks requiring the kind of rigorous AI validation outlined in the prompt.
Given the provided text, I must state that the information required to answer the prompt's specific questions about AI device acceptance criteria and a study proving it meets them is NOT present.
The document discusses imaging system performance and safety, but not AI model performance against explicit clinical acceptance criteria.
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(276 days)
Midmark Corporation
The Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and the Ritter M9D AutoClave® Automatic Sterilizer can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters on the following page for detailed information.
The Midmark and Ritter M9 and M11 UltraClave and Ritter M9D AutoClave Self-Contained steam sterilizers are designed to sterilize medical, surgical, laboratory, and dental items, using pressurized steam. The M9 UltraClave models include a variation designated as the M9D Autoclave, the only difference being that the M9 UltraClave includes a motor to automatically open the door for drying and the M9D Autoclave is a manual model which requires the operator to open the door for drying. They are self-contained devices that are electrically powered with automatic controls for controlling time and temperature that are designed for safe, easy operation with minimal operator training.
The provided document describes the Midmark and Ritter M9 and M11 UltraClave Automatic Sterilizers and the Ritter M9D AutoClave Automatic Sterilizer, which are self-contained steam sterilizers used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its performance is evaluated based on its ability to achieve sterility For medical devices, the common performance criteria for sterilization are the achievement of a certain temperature and pressure for a specified duration, resulting in a Sterility Assurance Level (SAL) of 10^-6, meaning the probability of a single viable microorganism remaining after sterilization is one in a million.
The document implicitly defines acceptance criteria through the "Standard Cycle Parameters" and confirms the device's performance through validation studies.
| Acceptance Criterion (Standard Cycle Parameter) | Reported Device Performance (Achieved during validation) |
|---|---|
| Unwrapped Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 3 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Pouches Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 4 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Packs Cycle: | |
| Sterilizing Temperature: 250°F (121°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 30 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 15 psi (104 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Handpieces Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 4 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Microbiological Performance (SAL): | |
| Sterility Assurance Level (SAL): 10⁻⁶ | Achieved (demonstrated through biological indicator overkill method) |
| Physical Performance Requirements: | All aspects of the standard met. |
The document states: "Testing showed that the M9 and M11 UltraClave and the M9D AutoClave Self-Contained Steam Sterilizers meet all aspects of the standard, including physical and microbiological performance requirements."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the physical performance validation, temperature sensors were used to determine the thermal profile of the empty chamber for "three (3) full chamber runs for each pre-programmed cycle parameter" (Unwrapped, Pouches, Packs, Handpieces). For microbiological testing, "biological testing was conducted on fully loaded chambers." No specific number of "fully loaded chambers" or individual biological indicators (BIs) is explicitly stated for the test set, beyond the statement that BIs were inoculated in "most difficult to sterilize locations."
- Data Provenance: The studies were conducted by "MIDMARK Corporation." The country of origin for the data is not explicitly stated, but Midmark Corporation is based in Versailles, Ohio, USA, suggesting the testing was likely conducted in the USA. The data is prospective, generated specifically for these validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (steam sterilizer) does not typically involve human experts in establishing the "ground truth" in the same way an AI diagnostic tool would. The ground truth for sterilization efficacy is established by scientific standards and laboratory methods.
- Number of Experts: Not applicable in the context of human interpretation. The "experts" are the scientific and technical personnel who designed and executed the validation protocols based on established sterilization standards.
- Qualifications of Experts: Not explicitly stated, but implied to be qualified personnel in sterilization science, microbiology, and engineering, familiar with relevant standards (e.g., ANSI/AAMI ST55).
4. Adjudication Method for the Test Set
Not applicable. Sterilization testing is based on objective, quantifiable measures (temperature, pressure, time, and biological indicator kill rates) rather than subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a standalone medical device (sterilizer), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Yes, a standalone performance study was conducted. The entire validation process, as described, evaluates the device's intrinsic mechanical and microbiological performance. The sterilizer operates autonomously through software-controlled microcontrollers (as described in the "Device Description") to achieve the specified sterilization cycles. The human operator initiates the cycle and loads/unloads the device, but the sterilization process itself is algorithmic (pre-programmed cycles and control loops) and standalone.
7. Type of Ground Truth Used
The ground truth used is based on established microbiological and physical standards for sterilization, specifically:
- Biological Indicator Overkill Method: This is a gold standard for demonstrating sterilization efficacy. Geobacillus stearothermophilus spores are highly resistant, and their complete inactivation (achieving a 10⁻⁶ SAL) confirms the sterilization process is effective.
- Physical Parameters: Measurement of temperature, pressure, and time profiles within the chamber ensure that the physical conditions required for sterilization were met.
- Reference Standards: The studies were conducted "in accordance with ANSI/AAMI ST55: 2010/(R)2014," a recognized standard for tabletop steam sterilizers, which defines the ground truth for performance requirements.
8. Sample Size for the Training Set
Not applicable. This is a physical device (sterilizer) with an embedded operating algorithm, not an AI model that undergoes "training" on a dataset in the typical machine learning sense. The device's control system is developed through engineering design and robust testing, not statistical training on large datasets.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8. The "ground truth" for the device's operational parameters (e.g., control logic for heating, venting, sterilizing timing) is established through engineering principles, design specifications, and adherence to regulatory and industry standards for steam sterilization.
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(128 days)
Midmark Corporation
The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:
· Noninvasive blood pressure for adult and pediatric patients (3 years and above)
- · Pulse rate for adult and pediatric patients
- · Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients
- · Body temperature measured at Temporal Artery for adult and pediatric patients
The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
The IQvitals Zone is designed to be used for measuring and monitoring systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. All functions of the device are performed via the touch screen display, except the power on/off function, which is a separate button on the back of the device.
The IQvitals Zone can be wirelessly connected with low energy Bluetooth to mobile computers or be connected with a USB cable to computers and has the ability to send the measurement results to the computers.
The device has a rechargeable lithium ion battery and two mounting options: a mobile cart and a wall mount. All vitals parameters can be simultaneously measured and easily viewed on the touch screen display or the connected computer. Temperature is measured at Temporal Artery and the Temperature Probe is connected serially to the IQvitals Zone.
The IQvitals Zone is a multi-parameter vital signs monitor intended for use by clinicians and medically qualified personnel for measuring and monitoring noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature at the temporal artery for adult and pediatric patients (3 years and above).
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The provided document presents the performance characteristics of the IQvitals Zone and compares them to predicate devices. This comparison implicitly serves as the acceptance criteria for the device, demonstrating that its performance is substantially equivalent to legally marketed devices. Since the device is a vital signs monitor designed to directly measure physiological parameters, the "algorithm only" or "standalone" performance is inherent in these functional specifications.
| Characteristic | Acceptance Criteria (Predicate Device K072516, K101445, K060576, K110028) | Reported Device Performance (IQvitals Zone) |
|---|---|---|
| NIBP Monitor Module | ||
| Measurement Accuracy | ± 5 mmHg (standard deviation |
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(131 days)
MIDMARK CORP.
The indications for use of the Progeny Vantage Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometic radiographic examinations for use in orthodontic treatment planning and evaluation.
The Progeny Vantage Panoramic X-Ray System is an extraoral radiographic imaging system for producing digital radiographs in panoramic and cephalometric views of the teeth, jaw and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation, Digital Image Receptor, Rotating C-Arm for tubehead and image receptor mounting, Overhead Arm, Elevating Column, Patient Positioning Table, Electronic Control Unit, Computer Display Workstation, 8 ft. coil cord with exposure switch, Optional cephalometric extension arm.
Here's an analysis of the acceptance criteria and the study performed for the Progeny Vantage Panoramic X-Ray System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for image quality. Instead, the acceptance is based on a determination of "at least as effective as" predicate devices by expert consensus.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image quality deemed acceptable for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | Two licensed dentists deemed image quality acceptable and effective. |
| Image quality deemed at least as effective as predicate devices (Instrumentarium OP200D and Planmeca ProMax). | Two licensed dentists concluded Progeny Vantage images were at least as effective as Instrumentarium and Planmeca images. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The clinical test involved images taken of "a skull phantom". This suggests a sample size of one skull phantom.
- Data Provenance: The images were specifically generated for the purpose of this K122643 submission through a clinical test using the Progeny Vantage device itself, as well as images from predicate devices. The text doesn't specify a country of origin beyond the device manufacturer being based in Lincolnshire, IL, USA. This appears to be a prospective test conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two licensed dentists.
- Qualifications of Experts: They are described as "licensed dentists." No further details regarding their years of experience or specialization (e.g., oral radiologist) are provided in the document.
4. Adjudication Method for the Test Set
The document states: "Both dentists deemed that the image quality was acceptable..." and "...concluded that the Progeny Vantage images were at least as effective as the Instrumentarium and Planmeca images."
This indicates an unspecified consensus or individual agreement model. There's no mention of a formal adjudication process like 2+1 or 3+1, but rather a collective conclusion from both reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- No AI assistance is mentioned in the context of this device. The device is an X-ray system, not an AI-powered diagnostic tool. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is an X-ray imaging system. Its "performance" is the quality of the image it produces, which is then interpreted by a human (dentist). It does not have an autonomous algorithm that would perform a standalone diagnostic function.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's image quality was established through expert consensus/opinion by the two licensed dentists. They reviewed the images and made a subjective judgment on their acceptability and comparative effectiveness against predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This document describes a traditional medical device (an X-ray system), not a machine learning or artificial intelligence algorithm that would typically require a training set. The device's operation is based on established physics and engineering principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
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(211 days)
MIDMARK
The Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments.
The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpieces and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, console mount housing, and a junction box that houses a power supply and air/water regulators. Handpiece accessories or instruments can be added to the Unit, Midmark does not manufacture these accessories but, do provide means to connect them into the Unit. These include high and low speed pneumatic handpiece tubing, electric handpiece motors, scalers, intraoral cameras, curing lights, air/water syringe, and SE and HVE vacuum instruments.
Here's an analysis of the provided 510(k) summary regarding the Midmark Elevance dental delivery unit, focusing on acceptance criteria and supporting studies:
This 510(k) document is for a dental delivery unit, not an AI or imaging device. Therefore, the typical "acceptance criteria" and "study" framework involving performance metrics like sensitivity, specificity, F1-score, and ground truth established by experts is not applicable in the same way it would be for an AI-powered diagnostic tool.
Instead, the acceptance criteria for this type of device revolve around demonstrating substantial equivalence to a predicate device, primarily through engineering and regulatory compliance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) context) | Reported Device Performance (from 510(k) summary) |
|---|---|
| Technological Characteristics: | |
| - Indications for Use (consistent) | Found to have similar technological characteristics |
| - Function of Handpiece Accessories (consistent) | Found to have similar technological characteristics |
| - Performance of Handpiece Accessories (consistent) | Found to have similar technological characteristics |
| Safety and Efficacy: | |
| - No adverse impact from minor differences | Minor differences (centrally located controls, touchpad, proportional solenoid valves for air/water adjustment) determined to not have any impact on the safety or efficacy of the Elevance. |
| Non-Clinical Performance: | |
| - Design Verification (Qualification Run evaluation) | Conducted |
| - Electrical Safety (e.g., IEC 60601-1) | EN 60601-1-2:2007 Part 1-2 conducted; IEC 60601-1 Part 1 conducted |
| - Electromagnetic Compatibility (EMC) (e.g., EN 60601-1-2) | EN 60601-1-2:2007 Part 1-2 conducted |
| - Harmonic Current Emissions (e.g., EN 61000-3-2) | EN 61000-3-2:2006 +A1:2009 +A2:2009 Part 3-2 conducted |
| - Dental Equipment General Requirements (ISO 7494-1) | ISO 7494-1:2004 conducted |
| - Dental Equipment Water/Air Supply Requirements (ISO 7494-2) | ISO 7494-2:2003 conducted |
| Conclusion: | The data shows that the Elevance demonstrates substantial equivalence to the predicate as a Dental Delivery Unit. |
For the remainder of the questions, the answers will reflect the nature of device clearance (510(k) for a medical device that is not an AI/imaging diagnostic tool) rather than an AI performance study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/imaging diagnostic test set. The "testing" here refers to engineering and regulatory compliance tests on the physical device itself, not a dataset of patient images or conditions. The number of units tested for electrical safety or functional verification is not specified in the summary but would be determined by internal quality and regulatory standards for device manufacturing.
- Data Provenance: Not applicable in the context of clinical data provenance. The "data" comes from the physical testing of the Elevance device, likely performed in a lab setting by Midmark Corporation or a contracted testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. "Ground truth" in the AI/imaging sense does not apply here. The "truth" for this device relies on its adherence to engineering specifications and international standards (like ISO and EN).
- Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians who designed, built, and tested the device, along with regulatory specialists who ensured compliance with standards. Their qualifications would be in engineering, quality assurance, and regulatory affairs, not clinical medical expertise for diagnostic ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no ambiguous result or expert discrepancy requiring adjudication for this type of device testing. Tests either pass or fail based on predetermined criteria outlined in the relevant standards (e.g., specific voltage limits, pressure ranges, insulation resistance).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable as the Elevance is a dental delivery unit, not an AI or imaging device that would involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the Elevance is a dental delivery unit, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the AI/imaging diagnostic sense. The "ground truth" for this device is its adherence to established engineering specifications, safety standards (e.g., electrical, EMC), and functional performance criteria as defined by international standards (ISO, EN, IEC). It's about meeting an objective, defined physical state or performance level, rather than correlating with a clinical diagnosis or outcome.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The Elevance is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. As there is no AI model or training set, there is no "ground truth" to establish for a training set.
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(97 days)
MIDMARK CORP.
ClearVision is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
ClearVision is a digital imaging system for dental radiographic application. The product is to be used for routine dental radiographic examinations such as bitewings, periapicals, etc. Two different sized sensors (size 1 and size 2) are utilized to image different anatomy and for different patient sizes. The CMOS sensor connects directly to a USB connection in a PC without the need for an intermediate electrical interface. ClearVision works with a standard dental intraoral x-ray source without any connection to the x-ray source. ClearVision captures an image automatically upon sensing the production of x-ray and after the x-ray is complete, transfers the image to an imaging software program on the PC. Disposable sheaths are used with each use to prevent cross-contamination between patients.
This provides an analysis of the provided text regarding the ClearVision Digital Sensor System.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ClearVision Digital Sensor System are derived from its comparison to predicate devices (Schick CDR and Gendex GXS-700) and general engineering requirements. The reported device performance indicates equivalency or superiority to these predicates.
| Acceptance Criteria Category | Specific Criteria/Test | Predicate Device A (Schick CDR) Performance | Predicate Device B (Gendex GXS-700) Performance | ClearVision Sensor Performance | Met? |
|---|---|---|---|---|---|
| Imaging Performance | Image Line Pair Phantom | - | - | Equivalent to GXS-700, Superior to Schick CDR | Yes |
| Image Aluminum Step Wedge | - | - | Equivalent to GXS-700, Superior to Schick CDR | Yes | |
| Image Tooth Phantom | - | - | Equivalent to GXS-700, Superior to Schick CDR | Yes | |
| Electrical Safety | IEC 60601-1 compliance | - | - | Meets requirements | Yes |
| EMI/EMC | IEC 60601-1-2 compliance | - | - | Meets requirements | Yes |
| Durability | Sensor housing and cable mechanical testing | - | - | Met all specified requirements | Yes |
| Reliability | Consistent image capture and transfer over extended life | - | - | Completely reliable | Yes |
| Image Quality Consistency | Consistent over expected lifetime exposures to radiation | - | - | Meets requirements | Yes |
| Hermetic Classification | IP67 per IEC 60529 | - | - | Meets requirements | Yes |
Note: The document states "found to be equivalent to the Gendex GXS-700 in all three tests and superior to the Schick sensor in all three imaging tests," implying that the performance level of the GXS-700 served as the primary benchmark for "equivalency" for the ClearVision's imaging performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set used in the imaging performance comparison. It mentions "each sensor to image a line pair phantom, an aluminum step wedge, and a tooth phantom." This implies at least one instance of imaging each of these phantoms per sensor.
The data provenance is not explicitly stated. Given the context of a 510(k) submission and the nature of the tests (imaging phantoms), it is highly likely that this was prospective data generated in a controlled laboratory or engineering setting, likely within the United States where the company is based. There is no mention of patient data or clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of human experts to establish ground truth for the test set. The tests performed ("imaging a line pair phantom, an aluminum step wedge, and a tooth phantom") are objective, physical measurements against established standards for image quality and resolution (e.g., line pairs, step wedge density differences). Therefore, the "ground truth" would be inherent in the physical phantoms themselves and the objective metrics used to evaluate the images.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation methods appear to be objective and quantitative (e.g., measuring line pairs, density differences). Human interpretation or consensus for ground truth was not mentioned or implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a technical performance comparison of the device against predicate devices using physical phantoms, not a clinical study involving human readers or patient cases. Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described imaging performance comparison of the ClearVision sensor is a standalone assessment. The evaluation focuses solely on the device's ability to capture and produce images from phantoms, without any involvement of a human interpreter in the loop for diagnostic decision-making during the testing process. The device itself is a digital sensor, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for the imaging performance tests was objective, physical standards provided by the phantoms:
- Line pair phantom: Provides known spatial frequencies (lines per millimeter) to assess resolution.
- Aluminum step wedge: Provides known material thicknesses/densities to assess contrast and dynamic range.
- Tooth phantom: Likely provides a realistic but standardized representation of dental anatomy to assess overall image quality and detail capture.
8. The Sample Size for the Training Set
The document describes a physical medical device (a digital X-ray sensor), not an AI/machine learning algorithm. Therefore, there is no training set in the context of an algorithm or AI model. The device's "training" or development would have involved engineering design, prototyping, and iterative testing to meet specifications, but not a dataset for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since this is a physical device and not an AI algorithm, the concept of a "training set" and establishing ground truth for it is not applicable. The device's "ground truth" during its development would have been established through engineering specifications, material properties, and performance targets derived from scientific principles and a comparison to existing technologies.
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(26 days)
MIDMARK
The indications for use of the Progeny Vantage Extra-Oral Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The Progeny Vantage Panoramic X-ray System is an extraoral radiographic imaging system for producing digital radiographs in a panoramic view of the teeth, jaw, and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation. Digital Image Receptor Rotating C-Arm for tubehead and image receptor mounting Overhead arm Elevating Column Patient Positioning Table Electronic Control Unit Computer Display Workstation 8 ft. coil cord with exposure switch
The provided 510(k) summary for the Progeny Vantage Panoramic X-Ray System primarily focuses on demonstrating substantial equivalence to predicate devices through comparison of technical specifications and indications for use. It does not contain information about specific acceptance criteria related to device performance in terms of diagnostic effectiveness that would typically be evaluated in a study with a ground truth, human readers, or quantitative performance metrics like sensitivity and specificity.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document, as they are not present.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices by matching their characteristics. The "reported device performance" in this context refers to the device's technical specifications.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Progeny Vantage) |
|---|---|---|
| kVp | 60-84 kVp (within range of predicates) | 60-84 kVp |
| mA | 1-16 mA (within range of predicates) | 4-10 mA |
| Digital Sensor | Yes | Yes |
| Image Pixel size | 66 µm - 96 µm (within range of predicates) | 96 µm |
| Exposure Time | 2-17s (within range of predicates) | 8-10s |
| Image Profiles | Pan, TMJ, Ortho (matching predicates) | Pan, TMJ, Ortho |
| Operator Exposure Control | Deadman Switch | Deadman Switch |
| User Interface | Color Touch Screen / Keypad & LED Display | Color Touch Screen |
| X-Ray tube focal spot | 0.4mm² - 0.5mm² (within range of predicates) | 0.5mm² |
| Magnification | 1.2 - 1.3 (within range of predicates) | 1.2 |
| Column | Telescoping / Fixed | Telescoping |
| Construction | Aluminum castings/extrusions with plastic/metal | Aluminum castings with plastic/metal covers |
| Indications For Use | To provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures (matching predicates) | To provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures |
| Safety & Effectiveness (General) | Performance testing, software testing, hazard analysis, same indications as predicates | Performance testing and verification to meet product specifications, Software testing to validate software design and performance, Hazard analysis and risk level assessment, Same indications for use as predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document. The filing mentions "Performance testing and verification to meet product specifications" and "Software testing to validate software design and performance" but does not detail the size or nature of the test sets used for these evaluations, nor their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The application focuses on technical equivalence rather than a clinical study requiring expert assessment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study was not done, nor is it applicable, as the device is a panoramic x-ray system, not an AI-powered diagnostic tool for interpretation. Its function is to produce images, not to analyze them with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided, and it is not applicable given the nature of the device as an imaging system rather than an algorithm for standalone diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For an imaging device like this, ground truth for image quality assessments would typically involve objective measurements (e.g., spatial resolution, contrast-to-noise ratio) and potentially subjective evaluation by clinicians to confirm diagnostic utility. However, the document does not elaborate on how these were established.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" as the device is an imaging system, not a machine learning model requiring a training phase for its core function.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
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(116 days)
MIDMARK CORP.
The Midmark M3 UltraFast™ Automatic Sterilizer can be used in medical, dental, and veterinary offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters, in Table-1, on the following page, for detailed information:
The M3 UltraFast™ Automatic Sterilizer is a small table-top steam sterilizer that uses saturated steam at high temperature and pressure to kill infectious bio-organisms.
The device is composed of a water reservoir, an oscillatory pump, a small electric boiler, an ASME certified pressure vessel, surface heaters for drying, a removable door/tray assembly, an electric gear motor for opening and closing the door/tray, and a solenoid valve for venting. The action of all of these components is coordinated by an integral proprietary design electronic control system, which includes a PC board, an LCD display, and a user interface membrane switch. The entire device is enclosed by a plastic and steel case. External to this device is a condensation tank, which is connected to the back of the unit, via a plastic tube.
Three different fully automatic pre-programmed sterilization cycles with parameters specific to the different load characteristics provide fast and easy use for efficient instrument processing. This sterilizer provides both audible and visual notification upon cycle completion and will dry the load in accordance with the CDC guidelines. A programmable dry cycle allows the user to customize the dry times from 20-60 minutes. This sterilizer has integrated technology to let the operator know if they have low water in the reservoir, or a full external condensing tank eliminating the need to continually monitor water levels.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Midmark M3 UltraFast™ Automatic Sterilizer are a Sterility Assurance Level (SAL) of 10⁻⁶ for all three sterilization cycles. The reported device performance demonstrates that the device successfully meets this criterion for each cycle.
| Acceptance Criteria (Sterility Assurance Level - SAL) | Reported Device Performance |
|---|---|
| Unwrapped Cycle: 10⁻⁶ | Validated to a SAL of 10⁻⁶ for the Unwrapped Cycle |
| Pouches Cycle: 10⁻⁶ | Validated to a SAL of 10⁻⁶ for the Pouches Cycle |
| Low Temp Cycle: 10⁻⁶ | Validated to a SAL of 10⁻⁶ for the Low Temp Cycle |
| Thermal Conditions | Achieves and maintains steady state thermal conditions |
| Total Kill Endpoint Time | Established as a starting point for cycle development |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific "sample size" in terms of number of sterilization runs for the test set. However, it mentions "Repetitive testing" for the validation of each cycle, implying multiple runs were conducted.
The data provenance indicates that the studies were conducted by a "third party, SPSmedical Supply Corporation," on behalf of Midmark Corp. This suggests an independent laboratory performed the testing. The country of origin of the data is not specified, but given the submission to the FDA, it is highly likely to be the United States. The studies are prospective in nature, as they involve actively testing the device's performance to establish its efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The ground truth for sterilization efficacy (total kill endpoint and sterility assurance level) is established through standardized microbiological testing using biological indicators (Geobacillus stearothermophilus spores) rather than human expert opinion. Therefore, the concept of "experts" in the traditional sense of medical image interpretation (e.g., radiologists) is not applicable here. The experts involved would be microbiologists and validation scientists from SPSmedical Supply Corporation, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set:
Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of data where consensus is needed (e.g., image reading). This is not relevant for the type of testing performed for a sterilizer. The "adjudication" is based on objective scientific criteria: the complete kill of a specified number of bacterial spores, as measured by microbiological techniques, to achieve a defined Sterility Assurance Level (SAL).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the diagnostic performance of human readers, typically in medical imaging, and are not applicable to the performance evaluation of a sterilizer. The device's effectiveness is measured against objective microbiological and thermal criteria, not against human interpretation performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies conducted were standalone performance evaluations of the Midmark M3 UltraFast™ Automatic Sterilizer. The tests focused solely on the device's ability to achieve sterilization without human intervention during the sterilization cycle itself. The device is an automatic sterilizer, performing its function independently once initiated.
7. The Type of Ground Truth Used:
The ground truth used for the sterilizer's performance evaluation is microbiologically established sterility, specifically a 10⁻⁶ Sterility Assurance Level (SAL), based on the complete inactivation of Geobacillus stearothermophilus spores.
This includes:
- Biological Indicators: The use of Geobacillus stearothermophilus spores as a challenge organism. The "total kill endpoint study" directly measures the time required to inactivate these spores.
- Thermal Profiles: Measurement of temperature throughout the chamber to ensure consistent thermal conditions.
- Validation of Sterilization Cycles: Confirmation that specific cycles (Unwrapped, Pouches, Low Temp) consistently achieve the desired SAL under defined load conditions.
8. The Sample Size for the Training Set:
This information is not applicable to this type of device and study. "Training set" refers to data used to train a machine learning algorithm. The Midmark M3 UltraFast™ Automatic Sterilizer is a physical device, not an AI or software algorithm. Its performance is validated through defined testing protocols, not through a training/testing split of a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" for a physical sterilizer device. The device's operational parameters (e.g., temperature, pressure, time for each cycle) are designed and engineered by Midmark based on scientific principles of steam sterilization and validated through the performance studies described in the document.
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(41 days)
MIDMARK DIAGNOSTICS GROUP
The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only.
The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.
The Midmark Diagnostics IQmark® Vital Signs Monitor consists of the following three individual measurement Modules:
a. Noninvasive blood pressure (NIBP)
b. Pulse Oximeter
c. Temperature
In the Automatic or STAT Modes of operation, the NIBP Module automatically inflates an occluding cuff placed around the patient's arm or leg. It uses the oscillometric measurement technique to measure and record the patient's systolic and diastolic pressure as well as pulse rate. From these measurements the IQmark VSM also calculates the mean arterial blood pressure (MAP). Measurement results along with operator prompts and error messages are indicated on the front panel display. The frequency of NIBP determination can be selected by the operator at fixed times between one and ninety minutes. The Manual Mode of operation also covers a variety of clinical uses. A variety of reusable and disposable cuff types and sizes is available for adult, pediatric, and neonatal applications. The NIBP Module requires routine calibration and maintenance.
The Pulse Oximeter Module measures and records the patient's arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through tissue (SpO₂). Changes in absorption caused by pulsations of blood in the patient's vascular bed are used to determine arterial oxygen saturation and pulse rate. Oxygen saturation and heart rate are indicated on the front panel display. A bar graph display gives the user a pulse visual indication of waveform signal quality. An audible indicator can be enabled which automatically generates a sound each time the SpO2 sensor detects a pulse. The 1Qmark VSM utilizes the Masimo Set" oximeter. A variety of reusable and disposable sensor types and sizes is available for adult, pediatric and neonatal applications. These oximeter does not require routine calibration or maintenance.
The Temperature Module measures and records a patient's temperature in either the Predictive or Continuous Mode of operation using either oral (also used for axillary) or rectal probes. In the Predictive Mode, the thermometer's software predicts body temperature in about 15 seconds for oral and axillary temperatures. The IQmark VSM Temperature Module does not support Predictive Mode measurements for the rectal temperature probe. The default mode used by the IQmark VSM for oral temperature determinations is the Predictive Mode. The Continuous Mode is usually used for longer-term monitoring or when difficult situations prevent accurate patient temperature measurement in the Predictive Mode. Temperature probe covers are required and are available for the oral/axillary and rectal probes. The Temperature Module requires routine calibration and maintenance.
When the Alarm Setting Mode is activated, high and low alarm limits can be set (within specification and safety limits) for heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and SpO2.
Here's an analysis of the provided text regarding the Midmark Diagnostics IQmark® Vital Signs Monitor, focusing on acceptance criteria and supporting studies:
It's important to note that this document is a 510(k) Summary from 2007, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. It typically focuses on comparing the new device to existing ones rather than presenting full, detailed clinical study reports. As such, some of the requested information (like specific sample sizes for test sets, data provenance for clinical studies, number/qualifications of experts, adjudication methods, or MRMC studies) are not explicitly detailed in the provided summary as they would be in a comprehensive study report.
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (IQmark® Vital Signs Monitor) |
|---|---|---|
| NIBP Accuracy | +/- 5 mmHg, standard deviation no greater than 8 mmHg (CAS Medical 740 Series) | +/- 5 mmHg, standard deviation no greater than 8 mmHg |
| SpO₂ Accuracy (Adult) | 70-100%: ± 2 counts (CAS Medical 740 Series) | 70-100%: ± 2 counts |
| SpO₂ Accuracy (Neonatal) | 70-100%: ± 3 counts (CAS Medical 740 Series) | 70-100%: ± 3 counts |
| Temperature Accuracy (Continuous Mode) | ± 0.1 °C (± 0.2 °F), meet or exceeds ASTM E1112-00 (IVAC Model 2080 / Welch Allyn VSM) | ± 0.1 °C (± 0.2 °F), meet or exceeds ASTM E1112-00 |
| Temperature Accuracy (Predictive Mode) | + 0.6 °C (+ 1.0 °F) (IVAC Model 2080) | ± 0.6 °C (+ 1.0 °F) |
Study Details
Due to the nature of a 510(k) Summary, the provided text does not contain detailed clinical study reports with specific sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for clinical performance testing. The performance data is presented as meeting the same specifications as the predicate devices and relevant standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the 510(k) Summary. The document states that "The IQmark VSM has been tested for safety and efficacy" and "operational and performance specifications for each measurement module and for the IQmark Vital Signs Monitor as a system has been successfully verified and validated." However, specific sample sizes for human subject testing (if any were conducted for this submission beyond standard verification/validation) are not provided. The performance specifications are directly compared to predicate devices and industry standards (e.g., ANSI/AAMI SP10 for NIBP, ASTM E1112 for temperature).
- The Masimo Set™ oximeter module is mentioned, implying that its performance characteristics would be based on Masimo's established data, but details are not included here.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated in the 510(k) Summary. The summary refers to "verification and validation testing, safety, and performance testing," but does not detail the methodology for establishing ground truth via expert consensus for these tests, especially for clinical accuracy measurements. Accuracy claims are often supported by comparison to a reference standard rather than expert consensus on a diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. The testing described in the summary pertains to performance against established physical and electrical standards, and accuracy against reference measurements (e.g., direct blood pressure readings for NIBP, a reference thermometer for temperature, CO-oximeter for SpO2, which are typically considered the "ground truth" for these physiological measurements). Adjudication methods like 2+1 or 3+1 are more common in studies involving subjective interpretation (e.g., image reading) where expert consensus establishes ground truth.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The IQmark® Vital Signs Monitor is a measurement device for physiological parameters (NIBP, SpO₂, Temperature, Pulse Rate). It is not an AI-based diagnostic tool that assists human readers/clinicians in interpretation, so an MRMC study comparing human performance with/without AI assistance would not be relevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance specifications listed (e.g., NIBP accuracy, SpO₂ accuracy, Temperature accuracy) represent the standalone performance of the device's measurement modules. These values are determined through testing the device itself against reference standards, independent of human interpretation or intervention beyond operating the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Standards and Industry Standards:
- NIBP: Likely comparison to a reference method (e.g., invasive arterial line measurement) or established simulation protocols as per ANSI/AAMI SP10.
- SpO₂: Likely comparison to multi-wavelength oximetry (Co-oximetry) measurements on blood samples, or controlled desaturation studies.
- Temperature: Comparison against precision reference thermometers in controlled environments, as per ASTM E1112-00 requirements.
- Reference Standards and Industry Standards:
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The sample size for the training set:
- Not applicable in the context of this 510(k) Summary. This device is hardware-based for physiological monitoring and does not employ machine learning algorithms that would typically require a "training set" in the sense of AI/ML models. Any internal calibration data or development data are not described as a "training set" in this document.
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How the ground truth for the training set was established:
- Not applicable. As a traditional physiological monitor, the device doesn't use a "training set" in the modern AI/ML sense. Its operational parameters and accuracy are based on known physics, engineering design, and adherence to established medical device standards.
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