Search Results

Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the 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, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Synthes Mandible External Fixator consists of the following components: An adjustable parallel pin clamp - MR safe; 4.0/2.5 Schanz Screws, 2.0 mm K-wires; and 4.0 mm Titanium Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.

Based on the provided text, the "Synthes Mandible External Fixator" is a medical device. The document is a 510(k) summary, which is typically for demonstrating substantial equivalence to a predicate device, not for a study proving device performance against acceptance criteria in the traditional sense of a clinical trial for a new drug or novel medical device.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria are not applicable to this type of regulatory submission (a 510(k) for substantial equivalence).

Here's the breakdown of what can and cannot be answered from the provided text:

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

• Not Applicable. This document establishes substantial equivalence to a predicate device, not performance against specific, pre-defined acceptance criteria from a clinical study. The device is assessed based on its similarity in design, materials, and intended use to an already legally marketed device.

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

• Not Applicable. Since there isn't a performance study described in the document, there's no test set, sample size, or data provenance to report in this context.

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. As no performance study is described, there is no "ground truth" establishment by experts for a test set mentioned.

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

• Not Applicable. No test set or related adjudication method is mentioned in this 510(k) summary.

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 device is a mechanical external fixator, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.

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

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

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

• Not Applicable. No performance study generating ground truth is described.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a training set.

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

• Not Applicable. See point 8.

Summary of Relevant Information from the Document:

While the document does not provide details of a study meeting the requested criteria, it does describe the basis for its regulatory acceptance: Substantial Equivalence.

• Device Name: Synthes Mandible External Fixator
• Intended Use: "Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the 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, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects."
• Predicate Device: Synthes Mandible External Fixator
• Basis for Acceptance: "Documentation is provided which demonstrates that Synthes Mandible External Fixator is substantially equivalent to other legally marketed Synthes devices."

In the context of this 510(k) submission, the "acceptance criteria" are the FDA's regulatory requirements for demonstrating substantial equivalence to a predicate device, and the "study" is the submission of documentation (which could include engineering analysis, biocompatibility testing, material characterization, performance testing on components, etc., but not a clinical study showing superior or equivalent outcomes compared to a control group in the manner you're asking) demonstrating that the new device is as safe and effective as the predicate. The document states that such documentation was provided to the FDA.

Ask a specific question about this device

Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the 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, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Synthes Mandible External Fixator consists of the following components: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws; 2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.

The input document is a 510(k) Summary for the Synthes Mandible External Fixator. This document indicates the device's classification and its substantial equivalence to a predicate device based on mechanical test results. Product 510(k) summaries for surgical tools and implants typically include mechanical testing and comparison to predicate literature. These do not typically include clinical studies or data from AI models. Therefore, the requested information (performance criteria in a clinical study for an AI model) cannot be extracted from the provided text.

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

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

• Acceptance Criteria: The device is considered substantially equivalent to the predicate device.
• Reported Device Performance: "The new device is considered to be substantially equivalent to the predicate device based on mechanical test results."

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 available in the provided text. The evaluation was based on mechanical test results, not a test set of human data.

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. The evaluation was based on mechanical test results, not expert review of a test set.

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

• Not applicable. The evaluation was based on mechanical test results, not expert review of a test set.

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

• No, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical device (external fixator), not an AI-based diagnostic tool.

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

• Not applicable. This device is a physical medical device (external fixator), not an AI algorithm.

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

• The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device, as established through mechanical test results.

8. The sample size for the training set

• Not applicable. There is no mention of a training set for an AI model.

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

• Not applicable. There is no mention of a training set for an AI model.

Ask a specific question about this device