(124 days)
Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in pre-vacuum steam sterilization method. The subject instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Smith & Nephew Hip Arthroscopy Repair Instrument Repair Tray is a stainless steel tray provided with instrument holders, pin mat, and tiers. The tray 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 during the sterilization process.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "The Smith & Nephew Hip Arthroscopy Repair Instrument Tray must demonstrate safety and effectiveness for its intended use, conforming to AAMI ST77:2006 Containment Devices for reusable medical device sterilization.",
"Reported Device Performance": "Non-clinical validation testing was conducted for sterilization and functional strength, demonstrating that the device is safe and effective and meets the requirements of its pre-defined acceptance criteria and intended uses. The technological characteristics of the subject tray are identical to the predicate devices in terms of material of construction, design, and intended use. Performance testing was conducted in accordance with AAMI ST77:2006."
},
"2. Sample size used for the test set and the data provenance": "Not explicitly stated. The document mentions \"Non clinical validation testing\" and \"Performance testing\" without specifying the sample size of trays or sterilization cycles used for testing. The data provenance is internal testing by Smith & Nephew.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. This device is a sterilization tray, and its performance evaluation does not typically involve expert review of clinical images or data to establish ground truth in the way medical imaging AI models do. Performance is assessed through engineering and sterilization validation tests.",
"4. Adjudication method for the test set": "Not applicable. Performance is assessed through engineering and sterilization validation tests, not through human expert adjudication.",
"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": "Not applicable. This device is a sterilization tray, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a physical medical instrument tray, not a software algorithm.",
"7. The type of ground truth used": "Performance was evaluated against predefined engineering and sterilization standards (AAMI ST77:2006) and the functional requirements of the device (e.g., sterilization effectiveness, functional strength). The 'ground truth' is adherence to these validated performance parameters.",
"8. The sample size for the training set": "Not applicable. This device is a physical medical instrument tray, not a machine learning model that requires a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This device is a physical medical instrument tray."
}
§ 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).