(255 days)
The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap.
The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The 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. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.
The Smith & Nephew Gynecology Instrument Tray is a stainless steel tray provided with instrument holders, internal compartment and a pin mat. 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.
Here's a breakdown of the acceptance criteria and study information for the Smith & Nephew Gynecology Instrument Tray, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Method: Pre-vacuum steam | |
| Temperature: 132° C (270° F) | ||
| Exposure Time: 4 minutes | ||
| Drying Time: 30 minutes | ||
| Maximum Loaded Tray Weight: 8.4 lbs. | ||
| Device Types and Dimensions: |
- Hysteroscope: Length: 334mm Max., Diameter: 8mm Max., Lumen: 3.1mm Min.
- Handpiece: Length: 203mm Max., Diameter: 32mm Max., Lumen: 5.1mm Max.
- Sheath: Length: 230mm Max., Diameter: 9mm Max., Lumen: 4.6mm Min.
- Calibration Insert / Obturator: Length: 385mm Max., Diameter: 4.1mm Max.
- Diagnostic Sheath: Length: 390mm Max., Diameter: 2.9mm Max., Lumen: 1.9mm Min.
General: Must be able to contain and protect reusable surgical instruments during sterilization and allow optimal exposure to sterilant. | "Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses."
The document explicitly states the "Validated Sterilization Parameters" (which are listed as the acceptance criteria). While a detailed report of the sterilization efficacy (e.g., sterility assurance level achieved) is not provided in this summary, the statement confirms that the device was tested and found to meet these parameters. The device is also confirmed to accommodate the specified instruments at the given maximum weight. |
| Functional Strength | Capable of protecting reusable surgical instruments during transport, sterilization, and storage. | "Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses."
Similar to sterilization, the document asserts that functional strength testing was performed and the device met its pre-defined acceptance criteria. No specific quantitative data on strength (e.g., load capacity beyond sterilization weight, impact resistance) is detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test set used in the non-clinical validation testing. It mentions "non clinical validation testing" for sterilization and functional strength.
The data provenance is not specified beyond "non clinical validation testing." It doesn't indicate the country of origin of the data or whether it was retrospective or prospective. Given the nature of a sterilization tray, it's highly likely this testing was conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a physical device like a sterilization tray, "ground truth" would typically refer to objective measurements and observations performed by qualified laboratory personnel, rather than expert consensus on subjective interpretations (like in imaging diagnostics).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are usually relevant for studies involving subjective interpretation by multiple human readers (e.g., radiologists reviewing images) where discrepancies need to be resolved. For a sterilization tray, the validation involves objective physical and microbiological 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 provided and not applicable. An MRMC study is relevant for diagnostic devices (often AI-based) that assist human readers. The Smith & Nephew Gynecology Instrument Tray is a physical sterilization device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not provided and not applicable. This concept applies to AI algorithms. The device in question is a physical instrument tray.
7. The Type of Ground Truth Used
For this device, the "ground truth" would be established through:
- Objective Measurements: For dimensions, weight capacity.
- Physical Testing: For functional strength (e.g., durability, integrity after repeated use/sterilization cycles).
- Microbiological Testing: For sterilization efficacy (e.g., sterilization cycle validation using biological indicators to confirm sterility assurance level). This is implied by "sterilization validation."
The document states that performance testing was conducted in accordance with ANSI/AAMI ST77:2006 Containment Devices for reusable medical device sterilization, which outlines standard methods for establishing such ground truth for sterilization products.
8. The Sample Size for the Training Set
This information is not provided and not applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical product.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable, for the same reasons as point 8.
§ 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).