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The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:

• . Trauma
• . Reconstructive surgery
• . Orthognathic surgery (surgical correction of dentofacial deformities)

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient.

This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile (non-sterile implants must be sterilized prior to use).

MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.

The provided document is a 510(k) Summary for a medical device (MatrixMANDIBLE Plate and Screw System) and does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device.

Instead, this document describes a conventional medical device (bone plates and screws) and seeks to demonstrate substantial equivalence to previously cleared predicate devices based on:

• Identical/similar Indications for Use.
• Technological Similarities (principles of operation, configurations, material, screw compatibility).
• Technological Differences (slight width difference, absence of a straight configuration, one more hole in single angle configurations compared to one predicate).
• Non-Clinical Performance Data: An engineering assessment including cross-section analysis and finite element analysis was used to compare mechanical properties to predicate devices. This assessment determined the mechanical properties were comparable.
• No Clinical Performance Data: The document explicitly states, "No clinical testing was performed to support this submission."

Therefore, it is not possible to fill out the requested table and information as it pertains to an AI/ML device, as the provided input describes a different type of medical device submission.

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The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:

• Trauma
• Reconstructive surgery
• Orthognathic surgery (surgical correction of dentofacial deformities)

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw System.
These devices are offered non-sterile and must be sterilized prior to use. MatrixMANDIBLE screws are intended for single use.

Here's an analysis of the provided text regarding the Synthes MatrixMANDIBLE Plate and Screw System, focusing on acceptance criteria and the supporting study:

The provided document describes a 510(k) premarket notification for a medical device. This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "acceptance criteria" and "study" described will primarily revolve around mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical tests. Instead, it states that the performance of the proposed devices is "equivalent to or better than" the predicate devices. The reported device performance is presented as the results of the mechanical tests, which are implicitly compared against the predicate's performance.

Note: The summary document only states that the device's performance was "equivalent to or better" than the predicate. Specific numerical values for the predicate or the proposed device's performance are not provided in this 510(k) summary. For a full understanding of the acceptance criteria (e.g., specific thresholds or statistical equivalence margins) and the detailed results, one would typically need access to the full test report submitted to the FDA.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each mechanical test (e.g., how many screws were tested for pull-out strength).
• Data Provenance: The testing was "Non-Clinical Testing" performed by the submitter, Synthes (USA), which is based in West Chester, PA, United States of America. The data is retrospective in the sense that it's generated for the submission, but it's new data specific to the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the study described is non-clinical mechanical testing, not a clinical study involving expert judgment of medical images or patient outcomes. The "ground truth" here is objective physical force measurements.

4. Adjudication Method for the Test Set

This section is not applicable for non-clinical mechanical testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in clinical or image-based studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed to support this submission."

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

This section is not applicable. This device is a bone plate and screw system, a physical medical device, not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts here.

7. Type of Ground Truth Used

The ground truth used for the non-clinical testing was objective physical measurements of mechanical properties (e.g., force, torque) under controlled laboratory conditions, as defined by engineering standards. The "truth" is established by the direct measurement of these physical properties rather than by expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as #8.

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