(448 days)
The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize:
- Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
- Medical devices with single stainless-steel lumen with:
An inside diameter of 1mm or larger and a length of 125mm or shorter
An inside diameter of 2mm or larger and a length of 250mm or shorter
An inside diameter of 3mm or larger and a length of 400mm or shorter
- The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
- Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood.
- Intended user: trained nurse level or higher level of healthcare providers
The validated maximum load conditions
Total weight:
The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).
Usage of sterilization pouch:
The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.
The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant.
The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.
The provided text is a 510(k) summary for the LOWTEM Crystal 120, a low-temperature hydrogen peroxide sterilizer. It outlines the device's indications for use, its technical characteristics compared to predicate devices, and performance data. However, the document does NOT describe the specific acceptance criteria and detailed study that proves the device meets those criteria in the format requested.
The "Performance Data" section (Page 10 and 11) lists various tests performed, their objectives, and an acceptance criterion of "Pass / Fail." It also states "Result: Pass" for all listed tests. This section generally confirms that the device passed general safety, electromagnetic compatibility, risk management, usability, sterilant potency, and sterilization efficacy tests. However, it does not provide the detailed quantitative acceptance criteria (e.g., specific thresholds for D-value or log reduction) beyond "Pass/Fail," nor does it elaborate on the methodology, sample sizes, or expert involvement for the individual tests.
Therefore, based on the provided text, I cannot complete the requested table and answer the detailed questions regarding acceptance criteria and the comprehensive study that proves the device meets specific performance criteria.
The document primarily focuses on regulatory approval based on equivalence to predicate devices, not on a detailed clinical study demonstrating device performance against specific acceptance metrics in a human-in-the-loop or standalone AI context, as might be expected for an AI/ML medical device. This device is a sterilizer, not typically an AI/ML-driven diagnostic or therapeutic device.
Here's what I can extract and what is missing, based on your prompt's structure:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Test Objective | Acceptance Criteria (as reported) | Reported Device Performance (as reported) |
|---|---|---|---|
| IEC 60601-1-2 Edition 4.0 | General requirement for safety. Collateral standard Electromagnetic compatibility. Requirements and tests. | Pass / Fail | Pass |
| IEC 61010-1 Edition 3.1 | Safety requirements for electrical equipment for measurement, control and laboratory use. | Pass / Fail | Pass |
| ISO 14971 Edition 3.0 Risk management | Identification of the risk and the activities of risk management. | Pass / Fail | Pass |
| IEC 62366-1 Edition 1.0 Usability Test | Application of usability engineering to medical devices | Pass / Fail | Pass |
| AOAC Sporicidal Activity Testing | Sterilant potency testing conducted per AOAC Official Method 966.04 | Pass / Fail | Pass |
| D-value and total kill end point | Evaluation of the D-value examined and calculated and demonstration of >12 log reduction of Geobacillus stearothermophilus and its total kill endpoint tested in LOWTEM Crystal 120 sterilization system. | Pass / Fail | Pass |
| ½ cycle modified total kill end point verification- worst case load | Evaluation of the validation loads under reduced injection weight to demonstrate a modified total end point. | Pass / Fail | Pass |
| Determination of worst-case material for VHP | Performance to determine the worst material (the most resistant) of 23 compatible materials of the LOWTEM Crystal 120 sterilizer. | Pass / Fail | Pass |
| ½ cycle verification of mated surface (first entry) | Evaluation of the sterility of the mated surfaces packaged in double pouch within the worst-case validation load in the LOWTEM Crystal 120 Standard ½ cycle. | Pass / Fail | Pass |
| ½ cycle verification of mated surface (second entry) | Evaluation of the sterility of the mated surfaces packaged in double pouch within the worst-case validation load in the LOWTEM Crystal 120 Standard ½ cycle. | Pass / Fail | Pass |
| ½ cycle verification at multiple peroxide injection weight-worst lumen size | To determine the worst-case lumen size of the claimed lumens in the LOWTEM Crystal 120 Standard ½ cycle using reduced sterilant weights injected. | Pass / Fail | Pass |
| ½ cycle verification of Lumen claims and worst-case materials | To verify the ability to sterilize in LOWTEM Crystal 120 Standard ½ cycle' worst-case lumen sizes (1.0mm x 125mm and 3.0mm x 400mm) and the worst- case material (neoprene) for surface sterilization in worst case validation loads. | Pass / Fail | Pass |
| ½ cycle verification of worst-case material in double pouch | To verify the sterilization efficacy with the worst-case material (neoprene) packaged in double Tyvek pouch configuration in LOWTEM Crystal 120 Standard ½ cycle. | Pass / Fail | Pass |
| Evaluation of the system parameters | To confirm the sterilization efficacy using worst case validation load with worst case materials processed in LOWTEM Crystal 120 Standard cycle. | Pass / Fail | Pass |
| Final process qualification | To confirm the LOWTEM Crystal 120 Standard cycle performed in accordance with the sterilizer specification by inspecting the three lots of test accessories (SCBI, CI strip and CI tape) after sterilization cycle. | Pass / Fail | Pass |
| Simulated Use test | To verify the sterilization ability of representative worst- case devices processed in the LOWTEM Crystal 120 sterilization cycle. | Pass / Fail | Pass |
| Clinical In Use test | To demonstrate the ability of the LOWTEM Crystal 120 sterilizer to sterilize clinically soiled and cleaned medical devices. | Pass / Fail | Pass |
| Cytotoxicity Evaluation | To evaluate the compatible materials (23 materials) to determine the non-cytotoxicity of the materials extracts after processing in the LOWTEM Crystal 120 sterilizer. | Pass / Fail | Pass |
| Residual Evaluation | To evaluate the emission of hydrogen peroxide vapor in operator's breathing zone. The emitted level of hydrogen peroxide vapor was evaluated according to the OSHA hydrogen peroxide gas 8-hour Time Weighted Average (TWA) limit of 1ppm. | Pass / Fail | Pass |
Missing Information (Not available in the provided text):
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "maximum of 20 lumens per load" for validation testing and "a total weight of 8.9kg(19.6lbs)" for validation loads. It also mentions "three lots of test accessories" for final process qualification. However, specific sample sizes (e.g., number of test cycles, number of devices/items tested for each specific test) are not detailed.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not mentioned, as the device is a sterilizer and its performance is measured by sterilization efficacy (e.g., bacterial kill, D-value) rather than expert interpretation of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The tests for a sterilizer are objective performance measures (e.g., spore kill, chemical residuals) rather than subjective assessments 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:
- Not applicable, as this device is a sterilizer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The "standalone" performance here refers to the sterilizer's ability to sterilize, which is inherent to its function and is what the various performance tests assess. There's no AI algorithm performing a separate task.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For a sterilizer, the "ground truth" for sterilization efficacy is typically defined by standardized biological and chemical indicators, as well as validated physical parameters of the sterilization cycle. The document mentions "demonstration of >12 log reduction of Geobacillus stearothermophilus" and "test accessories (SCBI, CI strip and CI tape)" which are standard methods for assessing sterilization success.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device that requires a training set.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).