(146 days)
The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated. STERRAD Sterilization Systems are pre-set and the cycle parameters can not be adjusted.
The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated.
The provided text describes a 510(k) premarket notification for Karl Storz-Endoscope Sterilization Trays. It primarily focuses on the regulatory approval and the intended use of the sterilization trays with specific sterilization systems.
Unfortunately, the document does not contain the detailed information requested regarding the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or adjudication methods that would typically be found in a clinical study report or a detailed validation study.
The document is a letter from the FDA confirming substantial equivalence and an "Indications for Use" statement, with a table showing compatibility with specific sterilization systems and maximum product loads. These are statements of intended function and compatibility, not a report of performance metrics or specific study results against acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be provided based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for device performance in terms of efficacy or safety from a study. Instead, it provides a "Sterilization Compatibility and Max Load" table, which acts as a statement of intended performance under specific conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with STERRAD 100S System | |
| Flexible Endoscope Tray, P/N 39402AS | Not compatible (✓ is not present) |
| Camera Tray, P/N 39301HCTS | Compatible (✓ present) |
| Telescope Tray, P/N 39301BS | Compatible (✓ present) |
| Compatibility with STERRAD NX "Advanced" Cycle | |
| Flexible Endoscope Tray, P/N 39402AS | Compatible (✓ present) |
| Camera Tray, P/N 39301HCTS | Not compatible (✓ is not present) |
| Telescope Tray, P/N 39301BS | Not compatible (✓ is not present) |
| Max. Product Load Per Tray | |
| Flexible Endoscope Tray, P/N 39402AS | 1 flexible fiberscope, 1 fiber optic cable |
| Camera Tray, P/N 39301HCTS | 1 camera head |
| Telescope Tray, P/N 39301BS | 2 rigid telescopes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. 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)
This information is not provided in the document. The document describes a medical device, not an AI or diagnostic tool that relies on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not applicable/provided. The device is a sterilization tray, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a sterilization tray, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided within this document. For a sterilization tray, "ground truth" would likely relate to efficacy studies (e.g., microbial kill rates, material compatibility, maintenance of sterility) conducted as part of the validation process, but these details are not in the FDA letter.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).