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510(k) Data Aggregation
(108 days)
The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-12 HS1, 9-6-12 HS1, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-12 HS1, GR 9-6-12 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-H TOP 5000, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version.
The sterilizers are available in a carriage loader and a ground loader (GR) version.
The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and BowieDick Test cycles.
The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):
Here's a breakdown of the acceptance criteria and study information for the Belimed Steam Sterilizer MST-H TOP 5000, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological Performance Tests: | ||
| Sterilization Efficacy Validation (PreVac 270F 4S / 30Dry, 25 lbs wrapped instrument PCD) | Sterility assurance level (SAL) 10-6, time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle, moisture retention of less than 20% increase | Pass |
| Sterilization Efficacy Validation (PreVac 270F 4S / 25 lbs wrapped instrument PCD) | Sterility assurance level (SAL) 10-6, time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle | Pass |
| Physical Performance Test: | ||
| Chamber temperature profile | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Biological Performance Tests: For the "PreVac 270F 4S / 30Dry, 25 lbs wrapped instrument PCD," it states "Full cycle / 3 runs." For the "PreVac 270F 4S / 25 lbs wrapped instrument PCD," it states "Full cycle / 3 runs" and "Half cycle 2 minutes / 3 runs." This indicates a total of 9 runs for the biological performance tests (3 for the 30Dry full cycle, 3 for the 25lb full cycle, and 3 for the 25lb half cycle).
- Physical Performance Test: The "Chamber temperature profile" test mentions "with empty chamber," but does not explicitly state the number of runs or specific sample size beyond that.
- Data Provenance: Not explicitly stated. The document refers to "non-clinical testing" and the standards it complies with (ANSI AAMI ST8:2013, ANSI/AAMI/ISO 11138-3, ANSI/AAMI/ISO 14161). This suggests the data was generated through laboratory testing, likely by the manufacturer, in accordance with these U.S. and international standards. It does not provide information about country of origin of the data beyond "Belimed AG" being in Switzerland, or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are objective, performance-based tests against established standards for sterilization efficacy and temperature profiles. The "ground truth" here is the pass/fail criteria defined by these standards, not expert evaluation of subjective data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the context of these objective, performance-based tests. Adjudication methods like "2+1" or "3+1" are typically used for subjective evaluations (e.g., medical image interpretation) where multiple experts assess the same data and discrepancies need to be resolved. For device performance testing against defined metrics, the results are direct measurements compared to acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and would assess the impact of AI assistance on human performance. The device described is a steam sterilizer, which does not involve human interpretation in its operational performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The performance tests ("Biological Performance Tests" and "Physical Performance Test") evaluate the sterilizer's function itself (algorithm only, if one considers the sterilizer's programmed cycles as an algorithm). There is no "human-in-the-loop" aspect to the sterilizer's core function of sterilization during these tests.
7. The Type of Ground Truth Used
The ground truth used for the performance tests is based on defined performance standards and scientific parameters for sterilization efficacy and physical characteristics.
- For biological performance, the ground truth involves achieving a Sterility Assurance Level (SAL) of 10^-6 and a time-at-temperature (F0) of at least 12 minutes by half cycle, along with specific moisture retention percentages. These are objective, measurable outcomes derived from scientific principles of sterilization.
- For physical performance, the ground truth is the chamber temperature profile being within a specific range (+3°C / +6°F and -0°C / -0°F of the target temperature).
These are not based on expert consensus, pathology, or outcomes data in the typical medical diagnostic sense, but rather on engineering and microbiological performance standards.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a steam sterilizer, a medical device with pre-programmed cycles and physical components, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device primarily involves its design, engineering, and adherence to established manufacturing and performance standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for the development of such a device stems from engineering specifications, regulatory standards (e.g., ANSI/AAMI ST8:2013), and validated sterilization principles rather than a labeled dataset used to train an AI model.
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(107 days)
The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.
The Belimed Steam Sterilizers MST-H, models 9-6-9, 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are available in a carriage loader and a ground loader (GR) version.
The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.
The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):
The provided text describes the Belimed Steam Sterilizer MST-H TOP 5000 and its equivalency to a predicate device, focusing on non-clinical performance and a summary of performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the sterilizer are demonstrated by meeting the requirements of ANSI/AAMI ST8:2013. The reported device performance is described for specific cycles.
| Acceptance Criteria (Set by ANSI/AAMI ST8:2013) | Reported Device Performance (Belimed Steam Sterilizer MST-H) |
|---|---|
| Sterility Assurance Level (SAL) of at least 10^-6 | Achieved an SAL of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 minutes by half cycle (for Prevac cycle with 25 lbs tray capacity). |
| Moisture retention of less than 20% increase in pre-sterilization weight of the towel | Demonstrated moisture retention of less than 20% increase in pre-sterilization weight of the towel (for Prevac cycle with 25 lbs tray capacity). |
| No wet spots on the outer wrapper | Exhibited no wet spots on the outer wrapper (for Prevac cycle with 25 lbs tray capacity). |
| Qualified according to AAMI ST8:2013 section 5.5.4 | Prevac cycle with maximum tray capacity changing to 25 lbs was qualified according to AAMI ST8:2013 section 5.5.4. |
| Qualified according to AAMI ST8:2013 section 5.5.5.1 | Immediate Use Gravity cycle with maximum tray capacity changing from 17 lbs. to 25 lbs. was qualified according to AAMI ST8:2013 section 5.5.5.1. |
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 cycles or tests performed for the verification studies. It mentions that the sterilizer was "validated to meet the requirements of ANSI/AAMI ST8:2013." The data provenance is implied to be from the manufacturer's own internal testing ("Belimed validates its sterilization cycles... Prior to release, Belimed Steam Sterilizer MST-H were validated..."). It is a retrospective summary of testing that has already occurred. The country of origin of the data is not specified directly, but the manufacturer (Belimed AG) is based in Switzerland and has a U.S. agent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The "ground truth" for a steam sterilizer's performance is typically established through adherence to recognized consensus standards like ANSI/AAMI ST8:2013, which outline methodologies for testing and defining effective sterilization. The document does not describe a process involving human expert review of test results for ground truth establishment beyond meeting the standard's requirements.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the testing is for steam sterilizer efficacy, it's unlikely to involve traditional adjudication methods like 2+1 or 3+1 typically used for diagnostic AI devices. The "adjudication" would be based on whether the physical and biological indicators used in the validation tests meet the pass criteria defined by the relevant standards.
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
Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The performance described is inherently standalone in terms of the device's function. The "device performance" refers to the sterilizer's ability to sterilize materials according to pre-programmed cycles and validated parameters, without human intervention in the sterilization process itself (beyond loading and selecting the cycle). The validation studies assess the sterilizer's function alone against the defined standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for assessing the sterilizer's performance is based on scientific and engineering principles, and adherence to recognized consensus standards. Specifically, the ground truth for sterilization efficacy is established by:
- Sterility Assurance Level (SAL) of at least 10^-6: A microbiological standard indicating a probability of one in a million chance of a non-sterile unit.
- Time-at-temperature sufficient to produce an F0 of at least 12 minutes: A measure of the lethality of the steam sterilization process.
- Moisture retention of less than 20% increase in pre-sterilization weight of the towel: A physical parameter indicating effective drying.
- Absence of wet spots on the outer wrapper: A visual indicator of effective drying.
These are objective, measurable criteria defined by standards like ANSI/AAMI ST8:2013 and verified through physical and biological indicator testing.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional medical device (steam sterilizer), not an AI/ML-based device that requires a "training set" in the context of machine learning. The "training" for such a device would refer to its design and engineering to meet specific operational parameters, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. As stated above, this device does not utilize a training set in the AI/ML sense.
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