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The CastleLoc Pectus Bar System is indicated for the treatment of Pectus Excavatum and other anterior chest deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Castleloc Pectus Bar System is a thoracic support product that repairs the thoracic wall, using minimally invasive surgical techniques to elevate the ribs and sternum to correct a type of chest wall deformity called pectus excavatum. Recommended implantation time is 2~3 years but may vary based on surgeon preference and patient.

This system includes various sizes of straight and curved Castleloc Pectus Bars. The appropriate bar is selected based on suitability for the patient body size. The Castleloc Pectus Bar, and Castleloc Pectus Stabilizer, Nut and Castleloc Pectus Claw Fixator for fixing the Castleloc Pectus Bar, are made of 316L (ASTM F138).

This FDA 510(k) clearance letter is for a medical device, specifically a Pectus Bar System, not an AI/ML powered device. As such, many of the typical acceptance criteria and study elements associated with AI/ML (like sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The acceptance criteria and supporting study described here are focused on demonstrating the mechanical performance and safety/effectiveness equivalence of the new device to existing legally marketed predicate devices, as required for traditional medical devices.

Here's an analysis based on the provided text, highlighting the differences from AI/ML criteria where relevant:

CastleLoc Pectus Bar System Acceptance Criteria and Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of physical samples (e.g., number of bars tested) for the mechanical bench testing. However, it implicitly refers to "test values" for the CastleLoc Pectus Bar System.
• Data Provenance: Not applicable in the context of mechanical bench testing; the "data" is generated from physical tests performed on the manufactured device components themselves rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This relates to mechanical bench testing of a physical device, not an AI/ML algorithm requiring expert interpretation of medical images or data. Ground truth for mechanical testing is established by physical measurement against engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. This relates to mechanical bench testing, where performance is measured objectively against an ASTM standard and compared to predicate device performance, not debated or adjudicated by experts.

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

• No. An MRMC study is relevant for AI/ML devices that impact human reader performance. This submission concerns a physical surgical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm. The "standalone performance" here refers to the device's mechanical integrity under various loads, which was tested.

7. The Type of Ground Truth Used

• The ground truth for this evaluation is based on established engineering standards (ASTM F382-17) for metallic bone fixation appliances and the performance characteristics of legally marketed predicate devices (K243357 CastleLoc Pectus Bar System and K191057 Park's Pectus System). The acceptance criterion is that the subject device's mechanical test results must be "similar or higher" than the reference product.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device submission, not an AI/ML submission that uses a training set of data.

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

• Not applicable. There is no training set for a physical medical device.

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