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Synthes Mini External Fixator stabilizes and provides treatment for fractures of maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects.

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The provided text is a 510(k) premarket notification and does not contain information about acceptance criteria or a study proving device performance as typically seen in a clinical study report.

The document is a letter from the FDA to Synthes (USA) confirming that their "Synthes (USA) Mini External Fixator" device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory classification and general controls provisions of the Medical Device Amendments.

The "Indications For Use" section lists the conditions for which the device is intended: "stabilizes and provides treatment for fractures of maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, burn maintenance, and bone-grafting defects."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided document. This type of information would typically be found in a separate clinical study report or a detailed technical submission, not in the FDA's 510(k) clearance letter itself.

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The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot.

Synthes Mini External Fixator includes the following components: Threaded Kirschner Wires, Wire-to-Rod and Rod-to-Rod Clamps, Rods and an Angled Connecting Bar. The wires are manufactured from stainless steel; the clamps and angled connecting bar from various grades of stainless steel, the rods from carbon fiber reinforced epoxy.

This appears to be a 510(k) summary for a medical device (Synthes Mini External Fixator) submitted to the FDA in 1996. The provided text describes the device and its comparison to a predicate device (Howmedica Mini Hoffmann External Fixation System) based on mechanical testing.

However, the request asks about acceptance criteria and a study proving a device meets these criteria in the context of AI or diagnostic performance, including details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies.

The provided document describes a mechanical device (external fixator) and its mechanical performance comparison to a predicate device. It does not involve any AI, diagnostic performance, image interpretation, or human-in-the-loop assessments. Therefore, most of the requested fields are not applicable to this type of device and study.

Here's how I can address the request based on the provided input:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text. This would refer to the number of fixator systems tested.
• Data Provenance: Not specified. It's likely an in-vitro laboratory study conducted by the manufacturer, but the location is not mentioned.

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)

• Not Applicable. This is a mechanical engineering test, not a diagnostic or AI performance study requiring expert human interpretation for ground truth. The "ground truth" would be the objective measurements of mechanical properties.

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

• Not Applicable. See point 3.

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 a mechanical device study, not an AI or diagnostic imaging study involving human readers.

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

• Not Applicable. This is a mechanical device, not an algorithm.

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

• Objective Mechanical Measurements: The "ground truth" would be the quantitative measurements of mechanical properties (e.g., stiffness, load-bearing capacity) obtained from standardized engineering tests.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning study, so there is no "training set." The study involved mechanical testing, likely of representative samples of the device and its predicate.

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

• Not Applicable. See point 8.

In summary, the provided document describes a 510(k) submission for a mechanical external fixator, focusing on its equivalence in mechanical performance to a predicate device. The questions posed are primarily relevant to AI/diagnostic performance studies, which do not apply to this specific document.

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