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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

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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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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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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.

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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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.

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