(51 days)
- ) Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head). 2.) Intertrochanteric fractures. 3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. 4.) Hip osteotomy Components in the InterTANTM CHS Plating System are for single use only.
The design of the InterTAN™ CHS Plating System is based on design features of the following currently marketed products: PERJ-IJOC™ Periarticular Locked Plating System, TriGen InterTAN Nail and CHS. InterTAN™CHS System is designed to address fractures of the proximal femur. System components include bone plates, lag screws, compression screws, and associated accessories. Like the predicate devices listed below, the subject components include various hole configurations and barrel angles of the contoured locking bone plates and various lengths of the lag/compression screws made from stainless steel and titanium. Further InterTAN™ CHS femoral locking bone plates, incorporate a screw-to-plate locking feature along the shaft of the plate which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text is a 510(k) summary for a medical device (InterTAN™ CHS Plating System) seeking clearance from the FDA. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) application would.
Therefore, the typical metrics and study designs used to demonstrate device performance in a clinical or diagnostic context (like sensitivity, specificity, expert consensus, MRMC studies, etc.) are not applicable to this document.
Instead, the "acceptance criteria" for a 510(k) in this context are primarily related to demonstrating equivalence in design, materials, and intended use as compared to already legally marketed predicate devices. The "study" that proves the device meets these criteria is typically a comparison of technological characteristics and design features, supported by engineering analyses (e.g., mechanical testing not detailed in this summary but common to such submissions) rather than patient-based clinical trials.
Below is an attempt to structure the information based on your request, but with the understanding that many fields will be "Not Applicable" or interpreted differently for a 510(k) of this nature.
Acceptance Criteria and Study for InterTAN™ CHS Plating System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance (as per 510(k) Summary) |
|---|---|---|
| Intended Use Equivalence | The device's indications for use must be substantially equivalent to predicate devices. | InterTAN™ CHS Proximal Femur Locking Bone Plates and Bone Screws are indicated for: (1) Intracapsular fractures of the proximal femur, (2) Intertrochanteric fractures, (3) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored, (4) Hip osteotomy. This is stated to be similar to legally marketed predicate devices. |
| Technological Characteristics Equivalence | The device must have technological characteristics (design features, materials) similar to predicate devices. | The design is based on features of PERI-LOC™ Periarticular Locked Plating System, TriGen InterTAN Nail, and CHS. Components include bone plates, lag screws, compression screws, and accessories with various hole configurations and barrel angles. Like predicates, made from stainless steel and titanium. Incorporates a screw-to-plate locking feature. Stated to share "similar technological characteristics" with predicate devices. |
| Material Equivalence | The device must be manufactured from materials similar to predicate devices. | Made from stainless steel and titanium, which are stated to be similar to the materials used in the predicate devices. |
| Performance Equivalence | The device's performance, as assessed through non-clinical means (e.g., mechanical testing, not detailed here), should be comparable to predicate devices. | The 510(k) relies on "similarities in design features, overall indications for use, and material composition" to demonstrate substantial equivalence. While not explicitly detailed in this summary, a 510(k) for an orthopedic implant like this would typically include mechanical testing data to demonstrate that the device meets relevant ASTM or ISO standards for strength, fatigue, etc., comparable to or better than predicate devices. This summary states "substantial equivalence is based on similarities..." and implies successful completion of such (unspecified) tests or analyses. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a clinical test set with patient data for this 510(k) summary. The "test set" in this case would refer to the specific designs, materials, and potentially mechanical test samples used for comparison. This document does not specify the number of test articles (e.g., plates, screws) tested in any engineering verification.
- Data Provenance: Not applicable for a clinical test set. The data presented here is related to the device's design, materials, and a comparison to predicate devices, not data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the clinical/diagnostic sense (e.g., confirmed diagnosis by a panel) is not established or discussed for this 510(k) summary. The "ground truth" here is the established design and performance of the predicate devices. Design expertise (e.g., engineers, orthopedic surgeons involved in design) would have been utilized during development, but this isn't detailed as "ground truth experts" for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for a 510(k) focused on design and material equivalence of a mechanical device.
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 describes a specific type of clinical study for diagnostic devices, particularly those involving AI. The InterTAN™ CHS Plating System is an orthopedic implant and does not involve AI or "human readers" in its direct use or evaluation documented here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical orthopedic implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For a 510(k) of this nature, the "ground truth" against which the new device is compared is primarily the established safety and efficacy profile of the legally marketed predicate devices. This "ground truth" is derived from decades of clinical use and regulatory clearance of these predicate devices. The new device demonstrates substantial equivalence rather than proving de novo safety and efficacy with independent ground truth data.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of machine learning for this orthopedic implant.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned, this question is not relevant.
§ 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.