(267 days)
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method
Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)
at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method
Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)
at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
This FDA 510(k) clearance letter for the SWEDEN & MARTINA SURGICAL TRAYS focuses on establishing substantial equivalence for a medical device that organizes, sterilizes, and transports dental surgical instruments. It is not an AI/ML powered device, and therefore the majority of the requested information (related to AI model performance, training data, ground truth, expert adjudication, etc.) is not applicable to this document.
The document primarily addresses the device's functionality related to steam sterilization.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The document provides information on the validated sterilization parameters. It doesn't present a table with explicit "acceptance criteria" versus "reported performance" for the device itself in the typical sense of a diagnostic or predictive AI model. Instead, it describes the conditions under which the device's sterilization function was validated.
| Acceptance Criteria (Implied by Validation Parameters) | Reported Device Performance (Validated Parameters) |
|---|---|
| Ability to be steam sterilized | Validated for steam sterilization (pre-vacuum dynamic-air-removal cycles) |
| Withstand specific temperature | 134 °C (273 °F) |
| Withstand specific exposure time | 4 minutes |
| Withstand specific drying time | Minimum 20 minutes |
| Accommodate maximum load | Maximum load of 740 grams for all device configurations |
| Available in specified sizes/dimensions | Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm) |
2. Sample sized used for the test set and the data provenance
- Sample size: Not explicitly stated in terms of a "test set" for performance evaluation in the context of AI. The validation was likely performed on representative samples of the surgical trays following established sterilization protocols.
- Data provenance: Not explicitly stated. However, the validation was "completed by" the manufacturer, Sweden & Martina S.p.A., and is part of their submission to the FDA. The tests would have been performed in a laboratory or clinical setting to a recognized standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device where expert ground truth is typically established. The "ground truth" here is adherence to sterilization standards and physical integrity of the device after sterilization.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML device requiring 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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device relates to the effectiveness of sterilization and the structural integrity of the trays after undergoing the specified sterilization cycles. This would be established through:
- Microbiological testing: E.g., using biological indicators or process challenge devices (PCDs) to confirm sterility after the cycle.
- Physical and functional integrity testing: Inspecting the trays for damage, deformation, or impaired function after repeated sterilization cycles.
- Adherence to recognized standards: Compliance with international or national standards for sterilization (e.g., ISO, AAMI).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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).