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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.

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.

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SWEDEN & MARTINA SURGICAL TRAY (Model "ZSHORTY-INT") is 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 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 ℃ (273 ℃) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

The validated load weight is 230 grams.

Not Found

The provided text is related to an FDA 510(k) clearance for a surgical tray. It discusses regulatory matters, product classification, and indications for use. It does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a medical device (a surgical tray) and not on the performance evaluation of an AI-powered or diagnostic device that would typically have acceptance criteria and associated study details as outlined in your prompt.

Ask a specific question about this device