(87 days)
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)
| Acceptance Criteria (for MR Safety) | Reported Device Performance (Satisfied) |
|---|---|
| Magnetic Resonance (MR) Conditional Safety Labeling | Determined to be MR Conditional based on test results. |
| Magnetic Induced Displacement Force (ASTM F2052-15) | Passed Acceptance Criteria |
| Magnetic Induced Torque (ASTM F2213-17) | Passed Acceptance Criteria |
| Radio Frequency Induced Heating (ASTM F2182-11a) | Passed Acceptance Criteria |
| MR Image Artifacts from Passive Implants (ASTM F2119-07) | Passed Acceptance Criteria |
Study Details (for MR Safety - Non-Clinical):
- 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.
- 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.
- Adjudication method: Not applicable for non-clinical physical testing.
- 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.
- 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.
- 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).
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring training data.
- 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.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.