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The Thorecon Rigid Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.

The Thorecon Rigid Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Sternal Cable of similar material. The Thorecon Rigid Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum, are manufactured from 420 or Custom 470 stainless steel. Thorecon devices are all single-use. The plates, complete with the necessary screws and instruments (torque driver and tensioner/cutter) required for completion of the surgery, are provided sterile in a disposable kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.

The provided text is a 510(k) Premarket Notification for the Thorecon™ Rigid Fixation System. It describes a medical device related to bone fixation, specifically for the sternum. The document focuses on regulatory approval and substantial equivalence to a predicate device, supported by non-clinical (mechanical and MR safety) testing.

Therefore, the information requested about acceptance criteria, study design for AI/human reader performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document concerns a physical medical device (implants, screws, etc.) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD) product.

The document states:

• Purpose of Submission: To obtain clearance of modifications to the Thorecon Rigid Fixation System, including the addition of MR Conditional Safety Labeling.
• Discussion of Supporting Non-Clinical Testing: "The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."
  • Mechanical Performance (Worst-Case Construct Assessment, Assessment of previously completed testing, Cerclage Dynamic Tension Testing)
  • MR Safety Evaluation following standards (ASTM F2052-15, ASTM F2213-17, ASTM F2182-11a, ASTM F2119-07)

Since the request is specifically about a study that proves a device meets acceptance criteria, and the provided text is about a physical medical device (Thorecon™ Rigid Fixation System) rather than a software or AI device, it's important to clarify that the "device" in question here is the implantable hardware.

Here's an interpretation of the acceptance criteria and the study based on the provided document, in the context of a physical medical device, while acknowledging that the original prompt's questions are generally geared towards AI/SaMD.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

The document does not explicitly list quantitative acceptance criteria in a table format with reported performance for individual tests. Instead, it states that all identified nonclinical tests "passed acceptance criteria established by the predicate device where applicable." This indicates a qualitative statement of compliance rather than specific numerical values.

1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, this exact table cannot be constructed with specific numerical values as they are not provided.

2. Sample Size Used for the Test Set and the Data Provenance
For a physical device's mechanical and MR safety testing:

• Sample Size: Not explicitly stated as "sample size" in the context of human data. For mechanical and MR safety testing of physical devices, samples would refer to the number of device units tested. This specific number is not provided in the summary.
• Data Provenance: This is not applicable in the context of human data or geographical origin for mechanical and MR safety testing of a physical device. These tests are laboratory-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for mechanical and MR safety testing of a physical medical device is established by physical measurements and compliance with engineering standards, not by expert human interpretation.

4. Adjudication Method for the Test Set
Not applicable. This applies to subjective human interpretations for ground truth, not objective physical testing.

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 is for AI-assisted image interpretation or similar cognitive tasks, not for a physical implantable device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI algorithms, not a physical implantable device.

7. The Type of Ground Truth Used

• For Mechanical Performance: Engineering specifications, material properties, and comparative performance against the predicate device.
• For MR Safety Evaluation: Compliance with established ASTM standards (F2052-15, F2213-17, F2182-11a, F2119-07) and FDA guidance for MR conditional labeling.

8. The Sample Size for the Training Set
Not applicable. This terminology refers to machine learning models. For a physical device, there isn't a "training set" in the AI sense. Design and manufacturing processes are iteratively refined based on engineering principles and test results.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is for AI models. Principles of engineering and materials science guide the design and manufacturing of the device.

Summary in relation to the document:

The provided document, a 510(k) Premarket Notification, is for a physical medical device (Thorecon™ Rigid Fixation System) which aids in sternal fixation. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for mechanical performance and MR compatibility. The document states that these tests were conducted and "passed acceptance criteria established by the predicate device where applicable" and complied with relevant ASTM standards and FDA guidance for MR safety, leading to the "MR Conditional" designation.

The questions in the prompt are largely tailored for Artificial Intelligence (AI) or Software as a Medical Device (SaMD) products, which typically involve performance evaluation based on human-interpreted data, often medical images. The nature of the Thorecon™ Rigid Fixation System and the testing described in this 510(k) summary (mechanical and MR safety) does not involve AI or human data interpretation studies of the kind implied by the questions.

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