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510(k) Data Aggregation
(131 days)
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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(97 days)
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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(116 days)
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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(147 days)
The M9 UltraClave™ is intended to be used in medical and dental 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 on the following page for detailed information.
The Midmark M9 UltraClave™ Steam Sterilizer uses saturated steam at high pressures and temperatures to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters.
Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically admits a controlled volume of water to the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and dries the items after sterilization is complete.
The provided documentation describes the Midmark M9 UltraClave™ Steam Sterilizer. This device is a sterilizer, not an AI/ML powered diagnostic device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable.
The "acceptance criteria" for this device are its "Standard Cycle Parameters" which define the time and temperature minimums for various types of sterilization programs. The "study that proves the device meets the acceptance criteria" is implicitly the general validation and testing undertaken by Midmark Corporation to demonstrate its sterilizing capabilities, as inferred by its 510(k) clearance by the FDA. The document states that "the M9 UltraClave™ meets performance standards that the predicate device does not," implying that internal testing was conducted.
However, detailed information on how performance was measured, including specific sample sizes, a detailed test protocol, or explicit statistical results is not present in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Program | Acceptance Criteria (Minimums) | Reported Device Performance (Implied by design and 510(k) clearance) |
|---|---|---|
| Unwrapped | Temperature: 270° F (132° C), Time: 3 minutes | Meets or exceeds these parameters to achieve sterilization. |
| Pouches | Temperature: 270° F (132° C), Time: 6 minutes | Meets or exceeds these parameters to achieve sterilization. |
| Packs | Temperature: 250° F (121° C), Time: 30 minutes | Meets or exceeds these parameters to achieve sterilization. |
| Handpieces | Temperature: 270° F (132° C), Time: 6 minutes | Meets or exceeds these parameters to achieve sterilization. |
| Programmable 1 & 2 | User defined: Temp 230°-275° F (110°-135° C), Time 3-90 min | Operates within user-defined parameters, ensuring proper coordination of time and temperature for effective sterilization (within 250°-275°F range for sterilization). |
2. Sample size used for the test set and the data provenance: Not applicable for this type of device (sterilizer). The "test set" would be various sterilization loads and cycles, but detailed data on the size or provenance of these internal tests is not provided in the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer is based on the inactivation of microorganisms, which is evaluated through established microbiological testing protocols rather than expert human interpretation.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone device in the sense that it performs sterilization cycles automatically, but it is not an algorithm-only device. Its performance is measured directly (e.g., against biological indicators, temperature/pressure sensors) rather than through comparison to human interpretation.
7. The type of ground truth used: The ground truth for sterilizers is based on the inactivation of resistant microorganisms (e.g., bacterial spores) under defined conditions. This is typically assessed using biological indicators (e.g., Geobacillus stearothermophilus spores) during validation studies, along with chemical indicators and physical monitoring of temperature, pressure, and time.
8. The sample size for the training set: Not applicable. This device does not use a training set in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.
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(15 days)
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(147 days)
The M4+9 EasyClave is to 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 at 270°F. Refer to Standard Cycle Parameters below for detailed information.
The Midmark M4+9 EasyClave Steam Sterilizer uses saturated steam at high pressures and temperatures and to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters.
Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically admits a controlled volume of water to the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and dries the items after sterilization is complete.
The provided text describes the Midmark M4-9 EasyClave Steam Sterilizer and its equivalence to a predicate device, the Midmark M-11 UltraClave Steam Sterilizer. However, the document does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement in the way typically found in performance studies for AI/software devices.
The information provided only states that:
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization of dental handpieces to an acceptable SAL (Sterility Assurance Level) when used with specific cycle parameters. | "To validate sterility claims for dental handpieces, the M4•9 was tested to the same protocol used to validate these claims for the predicate device. The resulting testing showed that, when used in accordance with Midmark's directions for use, the M4+9 can sterilize dental handpieces to an acceptable SAL." Specific Cycle Parameters: - Unwrapped: 132°C (270°F) / 186 kPa (27 psi) / 3:30 minutes - Wrapped: 132°C (270°F) / 186 kPa (27 psi) / 9 minutes |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the M4•9 was tested to the same protocol used to validate these claims for the predicate device," but the sample size of items or runs for this protocol is not mentioned.
- Data Provenance: Not specified. It's an in-house validation for a medical device manufacturer. The country of origin and whether it was retrospective or prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This is a validation study for a physical sterilization device, not a diagnostic or AI-powered imaging device that would typically rely on expert human interpretation for ground truth. The "ground truth" for sterilization is achieving a specific sterility assurance level (SAL), which is determined by microbiological testing, not human expert consensus on images or data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This is a sterilization validation based on physical parameters and microbiological results, not a study involving human readers or interpretation requiring adjudication.
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:
- MRMC Study: No. This is not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a steam sterilizer, its "performance" is its ability to sterilize. "Standalone" in this context would refer to its operation according to its pre-programmed cycles. The document confirms it "can sterilize dental handpieces to an acceptable SAL."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: Achieving an "acceptable SAL (Sterility Assurance Level)." This is typically established through biological indicator testing (e.g., spore strips) and monitoring physical parameters (temperature, pressure, time) to ensure the destruction of microorganisms. It is a scientific, objective measure of sterility, not expert consensus or pathology in the human diagnostic sense.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical sterilizer. It does not use a "training set" in the machine learning sense. Its programming is based on established sterilization principles and engineering, not data-driven learning.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for its design and pre-programmed cycles would be based on the scientific principles of heat and moisture sterilization to achieve microbial inactivation, which has been established through extensive research and standards in microbiology and sterilization practices.
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(89 days)
The M-11 UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat- and moisturestable, reusable equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters below for detailed information.
The Midmark M-11 Ultraclave Steam Sterilizer uses saturated steam at high pressures and temperatures and to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters, summarized below.
The provided text describes a steam sterilizer, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract the relevant information regarding the device's acceptance criteria and the study performed to meet those criteria.
Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its core function is to sterilize items according to established time, temperature, and pressure parameters. The key acceptance criterion is the ability to sterilize items to an acceptable Sterility Assurance Level (SAL).
The relevant "performance" here is defined by meeting these parameters for various cycles, and crucially, for the newly added indication for dental handpieces.
| Cycle | Temperature | Pressure | Time | Items to be Sterilized |
|---|---|---|---|---|
| Unwrapped | 132°C (270°F) | 186 kPa (27 psi) | 3 Minutes | Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment. |
| Pouches | 132°C (270°F) | 186 kPa (27 psi) | 15 Minutes | Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes. |
| Liquids | 121°C (250°F) | 104 kPa (15 psi) | 30 Minutes | Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact. |
| Packs | 121°C (250°F) | 104 kPa (15 psi) | 30 Minutes | Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes. |
Study Proving Device Meets Acceptance Criteria
Midmark developed a new test protocol specifically to validate sterility claims for dental handpieces.
- Sample size used for the test set and the data provenance: The document states that the protocol was designed to evaluate the M-11's ability to sterilize commercially available dental handpieces, "when presented as a worst-case challenge." It does not specify the exact number of handpieces or test runs, nor does it explicitly state the country of origin. The test was conducted by Midmark, implying internal, prospective testing.
- 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): Not applicable. This is a sterilizer, so "ground truth" would be established through microbiological testing (e.g., spore-kill assays), not expert review of images. The document does not specify the experts involved in the testing, but it would typically be microbiologists or sterilization validation specialists.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations (like medical image diagnosis), not for objective sterility testing.
- 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. This is not an AI-powered device, nor does it involve human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "study" described is a standalone performance validation of the sterilizer itself (algorithm only in the sense of the sterilizer's pre-programmed cycles).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for sterility is the absence of viable microorganisms to a scientifically accepted Sterility Assurance Level (SAL), typically 10^-6. This is established through microbiological testing using biological indicators (spore strips) placed in the most challenging locations and subsequent culture. The document states "The resulting testing showed that, when used in accordance with Midmark's directions for use, the M-11 can sterilize dental handpieces to an acceptable SAL."
- The sample size for the training set: Not applicable. There is no training set for a mechanical sterilizer; it operates based on pre-programmed physical parameters.
- How the ground truth for the training set was established: Not applicable.
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