(29 days)
Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
The Smith & Nephew instrument trays are designed to contain and protect reusable surgical instruments during processing, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
This 510(k) premarket notification for the Smith & Nephew Instrument Trays does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a comprehensive study proving device performance against those criteria. The provided document is a summary and regulatory approval.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization." It also lists "Validated Sterilization Parameters" which are essentially performance specifications for the sterilization methods the trays are compatible with.
| Acceptance Criteria (from Intended Use/Validated Parameters) | Reported Device Performance (implied by "Performance testing was conducted in accordance with AAMI ST77:2006") |
|---|---|
| Contain Smith & Nephew reusable surgical instruments | Tested in accordance with AAMI ST77:2006 (implying successful containment suitability) |
| Allow for convenient organized storage | Tested in accordance with AAMI ST77:2006 (implying suitability for storage) |
| Allow for sterilization | Tested in accordance with AAMI ST77:2006 (implying suitability for sterilization) |
| Allow for transport between usages | Tested in accordance with AAMI ST77:2006 (implying suitability for transport) |
| Suitable for Pre-vacuum steam sterilization (132C/270F, 4 mins exposure, 30 mins drying) | Tested in accordance with AAMI ST77:2006 (implying successful performance with these parameters) |
| Suitable for High Temperature Gravity Steam sterilization (132C/270F, 15 mins exposure, 70 mins drying) | Tested in accordance with AAMI ST77:2006 (implying successful performance with these parameters) |
| Not intended to maintain sterility individually | Intended to be used in conjunction with a validated sterilization wrap to maintain sterility |
However, the specific quantitative acceptance criteria (e.g., maximum temperature deformation, sterilant penetration rates, etc.) as outlined in AAMI ST77:2006 are not explicitly stated in this document. The "Reported Device Performance" column relies on the statement that testing was "conducted in accordance with AAMI ST77:2006," which implies the device met the requirements of that standard without providing the raw results or specific metrics.
Missing Information for the Study:
The 510(k) summary provided does not contain the following details about the performance testing:
2. Sample size used for the test set and the data provenance:
- The document mentions "Performance testing was conducted," but does not specify the number of trays tested, the type of instruments used, or the number of sterilization cycles performed.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. This type of testing is typically done in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of study does not involve human experts establishing "ground truth" in the way a diagnostic AI study would. The ground truth in this context is the successful sterilization and functionality of the tray and its contents, as determined by adherence to sterilization protocols and relevant standards (AAMI ST77:2006).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of device and testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This 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:
- Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is adherence to the requirements of the AAMI ST77:2006 standard for containment devices in sterilization, as well as the successful completion of specified sterilization cycles without damaging the instruments or the tray. This is validated through testing protocols, not expert consensus on medical images or pathology.
8. The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
In summary:
The provided document indicates that the Smith & Nephew Instrument Trays underwent performance testing in accordance with AAMI ST77:2006 to establish their substantial equivalence to predicate devices for their stated intended use and sterilization parameters. However, the specific details of this performance study (e.g., sample sizes, raw data, detailed methodologies beyond referencing the standard) are not included in this high-level 510(k) summary. Such details would typically be found in the full 510(k) submission document or supporting test reports, which are not publicly available in this extract.
§ 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).