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The Tritium® Sternal Cable Plate 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 Tritium® Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146).

The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.

The provided document is an FDA 510(k) clearance letter for the Tritium® Sternal Cable Plate System. It is a premarket notification for a medical device and not for a digital health/AI device. Therefore, the content does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161876 Tritium® Sternal Cable Plate System), primarily based on:

• Same indications for use.
• Same materials, manufacturing processes, and biocompatibility.
• Same principles of operation and fundamental technology.
• Same instrumentation and general surgical technique.
• Same sterility, shelf life, packaging, and bacterial endotoxin evaluation.
• Same mechanical performance.

The "Purpose of submission" states: "Obtain clearance for the following modification to the predicate K161876 Tritium® Sternal Cable Plate System: add magnetic resonance (MR) conditional safety labeling based on completed non-clinical testing." This indicates the primary study performed was related to MR compatibility.

Therefore, it is not possible to extract the requested information (acceptance criteria for AI/ML performance, study details for an AI/ML device, ground truth establishment, etc.) from this document.

The document describes non-clinical testing for MR safety. Below is a summary of the MR safety testing mentioned, which is not related to AI/ML device performance or clinical outcomes:

Acceptance Criteria and Study for MR Safety (Non-Clinical)

Study Details (for MR Safety - Non-Clinical):

1. Sample size used for the test set and the data provenance: Not applicable in the context of a typical clinical test set for AI. The "test set" here refers to the physical device components tested in an MR environment. The document does not specify the number of devices tested, but implied it was sufficient to meet the ASTM standards. Data provenance is not described as it is a non-clinical, in-vitro test.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for MR safety is established by adherence to international standards (ASTM) and measurable physical phenomena. No human experts are involved in establishing ground truth for these physical tests.
3. Adjudication method: Not applicable for non-clinical physical testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was a non-clinical MR safety study, not a clinical effectiveness study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
6. The type of ground truth used: Ground truth for MR safety is defined by the physical principles of magnetic resonance and the quantitative limits set by ASTM standards (e.g., displacement force, torque, temperature rise, artifact size).
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring training data.
8. How the ground truth for the training set was established: Not applicable.

Summary of why the requested information cannot be provided:

The provided FDA document is for a physical medical device (Tritium® Sternal Cable Plate System) used for bone fixation, and the clearance is based on substantial equivalence and non-clinical MR safety testing. It is not for a digital health product, an AI/ML device, or any software as a medical device. Therefore, the questions related to AI/ML device performance, human reader studies, ground truth establishment for AI, and training/test set sizes for AI algorithms are not relevant to this document.

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The Tritium Sternal Cable Plate 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 Tritium Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Sternal Cable Plate System can be used with traditional monofilament wire or Pioneer Sternal Cable. Instrumentation has been designed specifically for use with this system of implants, which may be implanted via an open or minimally invasive approach. The purpose of this submission is to add an additional implant to the predicate Tritium Sternal Cable Plate System.

This document describes the Tritium Sternal Cable Plate System, a medical device intended for stabilizing fractures of the anterior chest wall, including sternal fixation after sternotomy and sternal reconstructive surgical procedures.

Here's an analysis of the acceptance criteria and study aspects based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "The determination of substantial equivalence was not based on clinical performance data."

Therefore, there was no test set of clinical data (e.g., patient samples, images, or real-world outcomes) used to prove the device meets acceptance criteria. The evaluation was based on non-clinical performance data (engineering analysis and mechanical testing).

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

Since no clinical test set was used, there were no experts involved in establishing ground truth for a clinical test set. The evaluation relied on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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

No, an MRMC comparative effectiveness study was not done. The evaluation was based on non-clinical performance data and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

Not applicable. This is a physical medical device (sternal cable plate system), not an algorithm or AI system.

7. The type of Ground Truth Used:

The "ground truth" in this context refers to established engineering principles, material standards (ASTM F-67, ASTM F-136), and the performance characteristics of previously cleared predicate devices. The determination of device performance was based on:

• Engineering analysis: Demonstrating that the design met specified requirements.
• Non-clinical performance testing: Specifically, "static and dynamic tensile strength testing."
• Comparison to predicate devices: Establishing that its characteristics were "equivalent or comparable" and performed "as well as or better than the predicate."

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI or machine learning device, there is no "training set."

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

Not applicable, as there is no training set.

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The Pioneer Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

The Pioneer Sternal Cable Plate System contains various configurations of plates, some with integrated cables and crimps, and Ø2.7mm and 3.0mm self-drilling screws (lengths 8-20mm) to allow for multiple anterior chest wall and sternal repair and reconstruction options. The implants are manufactured from medical grade ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy. The implants may be implanted via an open or minimally invasive approach using Class I (exempt) orthopedic manual surgical instruments. The purpose of this submission is to add additional implant configurations to the system.

The acceptance criteria and study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for the static and dynamic tensile tests. It refers to "Static and Dynamic Tensile Tests" as the pre-clinical performance data. Since these are bench tests for mechanical strength, the "test set" would refer to the physical specimens of the device that underwent testing.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be entirely pre-clinical bench testing.

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

This information is not applicable as the study described is a pre-clinical bench test of mechanical properties, not a clinical study involving expert evaluation or ground truth based on medical diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is a pre-clinical bench test and does not involve human readers or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance

This information is not applicable as the study described is a pre-clinical bench test of a medical device (sternal cable plate system), not an AI-assisted diagnostic device.

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

This information is not applicable as the device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this pre-clinical study effectively comes from established engineering standards and requirements for mechanical strength and durability for sternal fixation devices. The comparison is made against the performance of legally marketed predicate devices, implying that their performance serves as the benchmark or "ground truth" for acceptable mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable as the study is a pre-clinical bench test of a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reasons as above.

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