(86 days)
The GTR Device is used for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter.
The Pioneer Greater trochanteric Reattachment Device (GTR) is a low profile, ovaloid stabilizer combined with multifilament cables are affixed to the ovaloid stabilizer and serve to attach the device to the trochanter providing fixation. Instruments that tension and lock the cable are provided with the GTR system. The GTR is offered in two (2) styles.
The GTR stabilizer is designed with proximal fingers which hook over the top of the proximal osteotomized trochanter and serve to position the device during fixation and apply a distal force after fixation. The extended version incorporates a distal plate stem.
The cables are affixed to the GTR unit are passed around or through the femur and back into the GTR Device. The ovaloid GTR unit is placed on the osteotomized trochanter which is then positioned on the femur. Proper tensioning is applied to the cables with a tensioning instrument. The cables are then locked in place by tightening a screw which crimps a sleeve and cable.
The provided text is a 510(k) notification summary for a medical device (GTR - Greater Trochanteric Reattachment Device). This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.
The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, etc.) is typically associated with studies demonstrating the clinical performance, diagnostic accuracy, or effectiveness of AI/ML-based devices or devices where a clinical study is explicitly required to show safety and efficacy.
The provided text does NOT contain information relevant to AI/ML performance, diagnostic accuracy, or clinical study details as described in your prompt. Instead, it focuses on the mechanical performance of the device (strength, fatigue) compared to a predicate device, which is typical for orthopedic implants.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document describes a mechanical performance study, not a study with acceptance criteria related to diagnostic accuracy, human reader performance, or AI standalone performance.
Here's how I would summarize the "performance data" presented, acknowledging it doesn't fit the AI/clinical study framework you've provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Equivalent) | Reported Device Performance (Pioneer GTR) | Unit of Measure |
|---|---|---|
| Static Loading: Equal to or greater than Dall-Miles Cable Grip System and stainless steel wire systems. | Static Loading: Equaled or was greater than Dall-Miles and stainless steel wire systems. | Implicit: Force/Load |
| Fatigue Loading: Equal to or greater than Dall-Miles Cable Grip System and stainless steel wire systems. | Fatigue Loading: Equaled or was greater than Dall-Miles and stainless steel wire systems. | Implicit: Cycles to failure / Load over cycles |
Explanation: The acceptance criteria were implicitly established by demonstrating substantial equivalence to the predicate device (Dall-Miles Cable Grip System) and traditional stainless steel wire systems. The "acceptance" was proving that the Pioneer GTR performed at least as well as these established technologies in static and fatigue tests.
The remaining points (2-9) are not applicable as the described study is a mechanical engineering test, not a clinical or AI performance study.
- 2. Sample sized used for the test set and the data provenance: Not applicable. Mechanical tests typically involve a certain number of device samples or test specimens, but this is not mentioned.
- 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 tests usually comes from standardized testing protocols and measurements, not expert consensus.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was a mechanical study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this relates to an orthopedic implant, not an algorithm.
- 7. The type of ground truth used: For mechanical tests, the "ground truth" is the measured physical properties: load at failure, number of cycles to failure, deflection, etc., adhering to engineering standards.
- 8. The sample size for the training set: Not applicable. There's no training set for a mechanical test of a physical device like this.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.