(16 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 transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
This document describes the Smith & Nephew Instrument Trays, which are sterilization trays. The information provided is a 510(k) summary for regulatory approval, focusing on demonstrating substantial equivalence to a predicate device. Therefore, a study meeting the specific criteria for AI/ML device evaluation (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or present in this submission.
Here's an analysis based on the provided text, focusing on what is available about acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Smith & Nephew Instrument Trays are based on their ability to contain and protect surgical instruments and allow for effective sterilization according to specific parameters. The reported performance confirms that the trays meet these parameters.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization, and transport between usages. Suitable for use in prevacuum steam and high-temperature gravity steam sterilization methods. Not intended to maintain sterility; requires a validated sterilization wrap. | The device meets the intended use. It is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage, and to allow optimal exposure of the tray's contents to sterilant. It is suitable for prevacuum steam and high-temperature gravity steam sterilization methods when used with a validated wrap. |
| Sterilization Parameters | Pre-vacuum steam: |
- Temperature: 132 - 135 C (270 F - 275F)
- Exposure Time: 4 minutes
- Drying Time: 30 minutes
High Temperature Gravity Steam: - Temperature: 132C (270F)
- Exposure Time: 15 minutes
- Drying Time: 70 minutes | The trays were successfully validated with these sterilization parameters. (Implied by the "Validated Sterilization Parameters" table in the Indications for Use and the statement "Performance testing was conducted in accordance with AAMI ST77:2006"). |
| Regulatory Compliance | Substantially equivalent to a legally marketed predicate device (Smith & Nephew Instrument Tray 510(k)# K073551) in Intended Use and Fundamental Scientific Technology, with no significant differences raising new questions of safety or efficacy. | The FDA determined the device is substantially equivalent to the predicate device, allowing it to be legally marketed. |
| Performance Standard | Conformity to AAMI ST77:2006 Containment Devices for reusable medical device sterilization. | Performance testing was conducted in accordance with AAMI ST77:2006. (Implies successful adherence to the standard's requirements for containment and sterilant exposure.) |
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. The filing is for a physical medical device (sterilization trays), not an AI/ML diagnostic or predictive algorithm. Performance testing details like specific sample sizes for physical testing, data provenance, or whether it was retrospective/prospective (in the context of clinical data) are not typically included in a 510(k) summary for such devices. The performance testing refers to engineering and sterilization validation, likely in a lab setting rather than with patient data.
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 applicable/not provided. Ground truth in the context of expert consensus is relevant for diagnostic or image interpretation AI/ML devices. For a sterilization tray, "ground truth" would relate to successful sterilization as determined by validated laboratory methods (e.g., biological indicators, chemical indicators) and engineering tests. The document mentions testing was done according to AAMI ST77:2006, which implies adherence to established scientific protocols, not expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used when multiple human readers interpret data to resolve disagreements or establish ground truth for AI/ML performance evaluation. For a physical device like a sterilization tray, performance is assessed through objective, instrument-based measurements and validated protocols (e.g., sterility testing).
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/not provided. MRMC studies are specific to AI/ML devices that assist human readers in tasks like image interpretation. This device is a physical sterile processing accessory and does not involve human readers interpreting data assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device 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 based on validated sterilization parameters and engineering tests according to the AAMI ST77:2006 standard. This involves objective measures of sterilant penetration and maintenance of physical integrity, rather than clinical outcomes or expert subjective assessment, as it is a device intended to facilitate sterilization, not diagnose or treat.
8. The sample size for the training set
This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.
§ 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).