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The purpose of the LIFETECH CASSETTE is to serve as an adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site. The device may be indicated for non-healing surgical wounds, burns, and pressure ulcers.

The purpose of the LIFETECH CASSETTE is to serve as an adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site. The device may be indicated for non-healing surgical wounds, burns, and pressure ulcers.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria. This document is a 510(k) submission for a medical device (Lifetech Cassette) seeking substantial equivalence to a previously marketed device.

Here's what can be inferred from the provided text regarding the closest relevant sections you've requested:

1. A table of acceptance criteria and the reported device performance

The document does not specify any quantitative acceptance criteria or provide performance data for the Lifetech Cassette itself. Instead, it relies on substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

No test set or data provenance is mentioned as this is a 510(k) submission based on substantial equivalence, not a clinical trial with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no test set or ground truth establishment by experts is described for performance evaluation.

4. Adjudication method for the test set

Not applicable, as no test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No MRMC study is mentioned. The submission focuses on substantial equivalence based on intended use and technological characteristics.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device described is a physical medical device (Topical Oxygen Chamber), not an algorithm or software.

7. The type of ground truth used

Not applicable, as a ground truth is not established or discussed for the purpose of performance evaluation. The "truth" in this context is the substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable, as this is a physical medical device and does not involve a training set as would be used for an algorithm.

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

Summary of what the document does provide:

• Device Name: Lifetech Cassette
• Intended Use: Adjuvant to normally accepted methods of wound and ulcer treatment and to prevent airborne organisms from landing on the site. Indicated for non-healing surgical wounds, burns, and pressure ulcers.
• Classification: Class III, but proposed for Class II.
• Substantial Equivalence: The submission asserts that the Lifetech Cassette is substantially equivalent to generic topical oxygen chambers (CFR 878.5650) and specifically to the device cleared by K920948.
• Rationale for Substantial Equivalence:
  1. Same intended use as topical oxygen chambers.
  2. Technological characteristics are substantially equivalent to generic and previously cleared predicate devices.
  3. Materials (polyvinyl chloride or polyethylene) are equivalent and nearly identical to similar products on the market.
  4. Sufficiently precise specifications for materials have been supplied.
• Sterilization: Gamma radiation or Ethylene Oxide, following AAMI guidelines, with validation for a minimum sterility assurance level of 10^-6.

The document is a regulatory submission for premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive new performance data or clinical study results against defined acceptance criteria.

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