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a) The Bone Plates are indicated for orofacial (maxilla or mandible) fracture or damage.
b) The Bone Screws are indicated for the fixation of the Bone Plate.

Bone Plate; Bone Screw

This document is a 510(k) clearance letter from the FDA for a bone plate and bone screw. It primarily focuses on regulatory approval rather than a detailed study description of how the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details is not present in the provided text.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report specific performance metrics for the bone plate and bone screw. The letter is a clearance for market entry based on substantial equivalence to predicate devices, not a detailed performance study report.

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.

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 provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 in the document. The device in question (bone plate and screw) is a physical medical device, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. The clearance is based on substantial equivalence, implying that the device's design and materials are comparable to existing, legally marketed predicate devices, rather than being validated against specific clinical ground truth data presented in this letter.

8. The sample size for the training set

This information is not provided in the document.

9. How the ground truth for the training set was established

This information is not provided in the document.

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The SL Type and SPL Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.

Not Found

The provided text describes an FDA 510(k) clearance letter for SL Type and SPL Type Orthodontic Screws. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot provide the requested information.

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The C Type, CT Type and Special Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for dental implants. It does not contain any information about acceptance criteria, study details, or device performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to be marketed. It does not include any performance data or a study description.

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