(284 days)
The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms.
The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
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This document is a 510(k) premarket notification from the FDA regarding the STATIM 2000/5000 G4 Cassette Autoclave. It outlines the intended use and sterilization cycles of the device but does not contain information on acceptance criteria for device performance, nor does it describe any study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information, which typically involves performance metrics like sensitivity, specificity, accuracy, F1-score, AUC, or other statistical measures, and details about a study conducted to validate these metrics.
The document only states the cycles, temperatures, times, and max loads for different types of instruments for sterilization. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness.
To directly answer your numbered points based only on the provided document:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The tables show intended use parameters (temperature, sterilization/drying time, max load, intended use) for different cycles, not performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
- 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 provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- 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 device is an autoclave, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an autoclave, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. For a sterilizer, ground truth would typically relate to microbiological inactivation verification (e.g., spore log reduction), but details are absent.
- The sample size for the training set: Not applicable. This device is an autoclave, not an AI model.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a medical device (autoclave), and as such, it focuses on the device's intended use and regulatory classification rather than detailed performance study results or AI-specific evaluation criteria.
§ 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).