(79 days)
The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.
The DePuy ACE Trochanteric Side Plate is an optional component of the DePuy ACE Captured Hip Screw System (CHS). The new plate has a proximal extension with three holes placed in a triangular configuration. The proximal extension is designed for fixation of trochanteric fracture fragments. Hip fractures with comminution of the greater trochanter can be better controlled with use of the DePuy ACE Trochanteric Side Plate. By passing screws through the proximal flare, fixation of the greater trochanter and anti-rotation of the femoral head is controlled throughout the length of the plate. The DePuy ACE Trochanteric Side Plate is initially offered in 4, 6, and 8 hole configurations. The DePuy ACE Trochanteric Side Plate is manufactured from Ti-6A1-4V alloy.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:
Disclaimer: This 510(k) summary is for a medical device (bone fixation plate), not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML performance metrics, ground truth, and expert adjudication are not applicable or cannot be determined from the provided text. The responses below reflect this limitation.
Acceptance Criteria and Device Performance Study (K970503)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance and Rationale (from 510(k) Summary) |
|---|---|
| Criterion 1: Material Composition | |
| The device must be made of a biocompatible and mechanically suitable material for internal fixation. | Performance: Manufactured from Ti-6Al-4V alloy. |
| Rationale: This is the same composition as the predicate device (DePuy ACE Captured Hip Screw Side Plate). This implies the material meets established safety and performance standards for bone fixation. | |
| Criterion 2: Indicated Use | |
| The device must be suitable for use in osteotomies, arthrodeses, and specific hip fracture types (intertrochanteric, intracapsular, and subtrochanteric). | Performance: Indicated for use in osteotomies, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric. Also specifically addresses comminuted trochanteric fractures. |
| Rationale: The new plate is indicated for the same hip fractures as the predicate device. The added proximal extension is designed to address comminuted trochanteric fragments, expanding its utility within the broader indications already covered by the predicate. | |
| Criterion 3: Mechanical Strength/Integrity | |
| The device must possess adequate mechanical strength for its intended application as a bone fixation plate. | Performance: Offers "superior strength characteristics." |
| Rationale: The summary states the new plate offers the same superior strength characteristics as the predicate device. While no specific quantitative metrics are provided, this comparative statement implies it meets or exceeds the mechanical performance deemed acceptable for the predicate device. | |
| Criterion 4: Surgical Technique/Compatibility | |
| The device must be compatible with existing surgical techniques or offer an acceptable and safe insertion method. | Performance: Uses the "same surgical technique for insertion" as the predicate device. |
| Rationale: This ensures that the device can be safely and effectively implanted by surgeons familiar with the predicate device, minimizing training burden and potential for surgical errors. The device also uses the same Captured Hip Screw Assembly as the predicate. | |
| Criterion 5: Design Features | |
| The device's design (e.g., profile, flexibility) should be appropriate for its application. | Performance: Described as "low profile design" and "inherently flexible allowing for plate conformity to the femur." Also offers a proximal hole for use of 6.5mm screw. |
| Rationale: These features are explicitly stated to be similar to or matching the predicate device, suggesting they are desirable characteristics for the intended use and contribute to patient outcomes and ease of use. The new proximal extension with three holes provides enhanced fixation for trochanteric fragments, addressing a specific clinical need without compromising overall design principles. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) summary describes a traditional medical device (bone fixation plate), not an AI/ML-powered device. Therefore, there is no "test set" in the context of an AI algorithm being evaluated for performance on data. The evaluation relies on substantial equivalence to a predicate device, based on shared materials, indications, mechanical properties, and surgical techniques.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point 2. No "ground truth" in the context of expert labels for data is established for this type of device submission. Device safety and efficacy are inferred through engineering analysis, material properties, and comparison to a legally marketed predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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
- No. This is not an AI/ML-powered device. A comparative effectiveness study with human readers assisting AI is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this type of device, the "ground truth" for substantial equivalence is implicitly the established safety and effectiveness of the predicate device, supported by engineering specifications, material standards, and clinical experience with similar devices. The evaluation here is based on physical and functional characteristics, not data labeling or clinical outcomes from a new study per se (in the context of a 510k).
8. The sample size for the training set
- Not Applicable. See point 2.
9. How the ground truth for the training set was established
- Not Applicable. See point 2.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.