(21 days)
The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.
The 833HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a large sized chamber and has the same control system and offers similar overall features as those on the 733HC Vacuum/Gravity Steam Sterilizers. These include: additional functionality, ease of use to the end user, large color display that will allow the user to choose from the entire list of available cycles, allows renaming and re-sequencing of sterilization cycles.
The provided document is a 510(k) summary for a steam sterilizer, not an AI/ML device, and thus does not contain information typically associated with studies proving device performance against acceptance criteria for AI algorithms. Therefore, most of the requested information (sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set information) is not applicable or present in this document.
However, I can extract the acceptance criteria and the statement regarding how the device meets them from the provided text.
Acceptance Criteria and Device Performance for Getinge Sourcing LLC Model 833HC Vacuum/Gravity Steam Sterilizer
This device is a steam sterilizer, and its performance is assessed against established industry standards for sterilization efficacy and safety, rather than through AI/ML model performance metrics. The core acceptance criterion for such a device is its ability to sterilize medical instruments effectively and safely according to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Standard | Reported Device Performance (Statement of Conformance) |
|---|---|
| AAMI ST8:2001 (Hospital Steam Sterilizers) | "This steam sterilizer meets the applicable requirements of AAMI ST8:2001..." |
| CSA-Z314.7 (Performance Standards) | "...and CSA-Z314.7 performance standards." |
| Substantial Equivalence to Predicate Device (Model 733HC) | "The 833HC Vacuum/Gravity Steam Sterilizer is a substantially equivalent device to that of the predicate device." "Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended." |
| Intended Use | "The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam." (The device is presented as capable of fulfilling this intended use through its design and adherence to standards). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a physical medical device (steam sterilizer), not an AI algorithm. Its performance is demonstrated through adherence to engineering and sterilization standards, not data analysis on a test set. There is no mention of "test set" in the context of data for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As a physical device, the "ground truth" for its efficacy is established by widely accepted microbiological principles and validated industry standards for sterilization, rather than expert consensus on a dataset.
4. Adjudication method for the test set:
- Not Applicable. No test set or adjudication process as defined for AI/ML algorithms is mentioned or relevant for this device.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a standalone physical device, but not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Established Sterilization Standards and Physical Testing: The "ground truth" for a sterilizer's performance is biological inactivation (killing microorganisms) as demonstrated through validation studies that adhere to standards like AAMI ST8. While direct biological indicator testing results are not provided in this summary, the claim of meeting the standards implies such validation was performed.
8. The sample size for the training set:
- Not Applicable. This device does not use a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not have a "training set."
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).