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The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.

The Acumed Rib Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the rib.

The Acumed Rib Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All nlates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.

The provided text is a 510(k) summary for a medical device (Acumed Rib Congruent Bone Plate System) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance criteria. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving performance cannot be extracted directly from this document.

However, I can extract what is implied and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The acceptance criteria are "implied" because the 510(k) process for this type of device often relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that if the materials, intended use, and technological characteristics are similar enough and meet recognized standards (like ASTM), the device is presumed to meet the safety and effectiveness criteria already established for the predicate devices. No specific quantitative performance metrics or thresholds are explicitly stated as "acceptance criteria" in this document.

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

• Sample Size for Test Set: Not applicable. The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that no specific test set of data was used to demonstrate performance against explicit criteria in this submission.
• Data Provenance: Not applicable for the reasons above.

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

• Not applicable, as no specific test set with ground truth was used for evaluation of this device in this submission.

4. Adjudication Method for the Test Set:

• Not applicable, as no specific test set was used.

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

• No. The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This type of study would fall under clinical or performance data.

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

• No. This device is a bone plate system, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is not applicable.

7. The Type of Ground Truth Used:

• Not applicable, as no specific test set with ground truth was used for evaluation of this device in this submission. The "ground truth" for this submission is essentially the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This device is a bone plate system, not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no "training set" for this type of device.

In summary: This 510(k) submission is based on demonstrating substantial equivalence to previously cleared devices by comparing device characteristics (materials, intended use, technological features). It explicitly states that performance data, clinical trials, and non-clinical tests are "not applicable" for this specific submission to clear the device. Therefore, the detailed study information you've requested beyond the comparison to predicate devices is not present in this document.

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