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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 Bone Plate with Cable's device is indicated for use where wire, cable, or band cerclage is used in combination with bone plates. The Bone Plate with Cable's device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the bone plate.

The Bone Plate with Cable's device consists of a bone plate with transverse holes for passage of multifilament cables. A cable is passed through the transverse bone plate hole, and then through a crimp. The crimp is typically positioned adjacent to the plate. The cable is locked into a tensioning device and tightened which applies compression to the plate and bone. The crimp and cable are then crimped with a crimping tool to lock the cable in place. Excess cable is cut and removed. Additional cables of the same system type maybe applied as required.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pioneer Laboratories Bone Plate with Cables device.

It's important to note that this 510(k) summary is from 1997, and the information presented is typical for the regulatory standards of that era. Modern medical device submissions often include more detailed performance studies and statistical analyses.

Acceptance Criteria and Study for Pioneer Laboratories Bone Plate with Cables Device

Based on the provided 510(k) Summary, the "Bone Plate with Cables" device underwent performance testing to demonstrate substantial equivalence to predicate devices, primarily focusing on mechanical strength and loading capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Observation: The document does not explicitly state numerical acceptance criteria (e.g., "must withstand X Newtons of force"). Instead, the performance is reported relative to existing systems. The "acceptance criteria" are implied to be "at least as good as or better than" the predicate devices.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of plates or cables tested). It refers to "tests of each of the systems."
• Data Provenance: The data is generated from performance testing conducted by the manufacturer, Pioneer Laboratories. The Country of Origin is the USA (where Pioneer Laboratories is based). The study is prospective in the sense that the testing was performed specifically to support the 510(k) submission for this new device.

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

This section is not applicable to this type of device and study. The "ground truth" for a mechanical device like a bone plate with cables is typically established through engineering principles, material science, and mechanical testing standards. It isn't based on expert consensus on interpretations as would be the case for diagnostic imaging. The "truth" in this context is the physical properties measured in a lab.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert assessments (e.g., in clinical trials or image interpretation studies). For mechanical testing, if there were any discrepancies in test results, standard engineering practices for repeatability, reproducibility, and retesting would be employed, not an adjudication process by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic imaging devices or software where human readers interpret medical images. This 510(k) is for a mechanical orthopedic implant, not a diagnostic device.

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

This question is not applicable as the device is a mechanical implant, not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, not in an "algorithm only" mode.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance study was based on mechanical testing results and comparison to established performance of predicate devices. The "truth" refers to the measured loading values and the device's ability to withstand forces, as determined by laboratory methods.

8. The Sample Size for the Training Set

This section is not applicable. The device is not an AI/ML algorithm requiring a "training set." Its design and performance are based on engineering principles and material properties, validated through mechanical testing.

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

This section is not applicable for the reasons stated above (not an AI/ML device).

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