(83 days)
InterTAN CHS Limited Collapse Set Screw is indicated for:
- 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).
- Intertrochanteric fractures.
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.
- Hip osteotomy .
InterTAN CHS Limited Collapse Set Screw is for single use only and is to be used with InterTANY CHS Plating System.
Subject of this Traditional 510(k) premarket notification is the InterTAN® CHS Limited Collapse Set Screw. The subject device is a line addition to the InterTAN® CHS Plate System cleared via K080434. The Limited Collapse Set Screw is designed to limit the amount of allowable collapse and prevent lateral advancement of the plate.
This document describes a submission for a medical device, specifically a "Limited Collapse Set Screw" for orthopedic use. The information provided is primarily focused on regulatory approval (510(k)) and establishing substantial equivalence to existing devices, rather than detailed performance studies against specific acceptance criteria in the way one might see for an AI algorithm or a diagnostic test.
Therefore, many of the requested categories for AI/diagnostic device performance studies (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance) are not applicable to this type of submission.
However, I can extract the relevant information regarding acceptance criteria and the "study" (mechanical testing) that helped meet them for this orthopedic device.
Here's the breakdown of the provided information within the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand expected in vivo loading without failure (Mechanical) | "A review of the mechanical data indicates that the Limited Collapse Set Screw is capable of withstanding expected in vivo loading without failure." |
| Substantial Equivalence to Predicate Devices (Regulatory/Design) | The device's "similarities in indications for use, design features, operational principles, and material composition" to predicate devices (InterTAN® CHS Plate System K080434 and DePuy PEAK FX Hip Plate K063509) were established. |
| Intended Use Adherence (Clinical/Indications) | The device is indicated for specific types of proximal femur fractures and hip osteotomy, aligning with predicate devices. |
| Material Composition Safety/Biocompatibility (Implied) | Not explicitly detailed in the provided text, but implied by substantial equivalence to metallic bone fixation fasteners. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For this type of orthopedic device, there isn't a "test set" of patient data in the sense of a diagnostic algorithm. Performance is assessed via mechanical testing and comparison to predicate devices.
- Data Provenance: The "mechanical data" is generated in a lab setting, not from clinical patient data. The provenance of the "design features, operational principles, and material composition" is from the manufacturer's internal development and testing, benchmarked against existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of typical AI/diagnostic device studies. "Ground truth" for this device's performance against mechanical criteria would be established by engineering standards and measurement equipment.
- Qualifications of Experts: The review of mechanical data would typically be conducted by qualified engineers and materials scientists within Smith & Nephew, and subsequently by FDA reviewers (e.g., orthopedic device specialists).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "adjudication" of a test set in the clinical/human-perception sense for this mechanical device. The mechanical testing results would be compared directly to pre-defined engineering pass/fail criteria.
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
- MRMC Study: No, not applicable. This is a mechanical implant, not a diagnostic imaging device or an AI application that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device (screw) that is implanted; it does not have an "algorithm-only" performance mode in the context of diagnostics. Its performance is its mechanical integrity and function within the human body.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Mechanical Performance: Established by quantitative measurements against engineering specifications and validated test methods (e.g., load testing, fatigue testing). This is a simulated performance ground truth against known physical stress.
- Substantial Equivalence: Pertains to comparison with the established characteristics (indications, design, materials) of legally marketed predicate devices, which have their own established performance and safety profiles. This is a regulatory/design ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This type of device does not involve machine learning or a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
Summary for K090656:
This 510(k) submission for the Smith & Nephew InterTAN® CHS Limited Collapse Set Screw focuses on demonstrating substantial equivalence to previously cleared predicate devices and confirming its mechanical integrity. The "study" mentioned is mechanical testing which demonstrated the device's ability to withstand expected in vivo loading. The acceptance criteria for this device are primarily related to its mechanical performance and its comparability in design, materials, indications for use, and operational principles to existing, legally marketed devices. The concept of "acceptance criteria" and "study" in this context is different from what would be applied to an AI or diagnostic device and therefore many of the specific questions are not directly relevant.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.