(30 days)
The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:
Compression Hip Screws/ IMHS
- Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
- Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
- Osteotomies for patients with diseases or deformities of the hip.
- Hip arthrodesis.
- Supracondylar fractures and distal femoral fractures using a supracondylar plate.
- Ipsilateral femoral shaft/neck fractures (long IMHS only).
HA Coated Lag Screws are for single use only.
HA (Hydroxylapatite) Coated Lag Screws are large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture. HA Coated Lag Screws are available in various sizes made from either 316L stainless steel or Titanium-6Al-4V metal materials.
The provided text describes a 510(k) summary for HA Coated Lag Screws, which is a medical device submission seeking market clearance based on substantial equivalence to existing devices. This type of submission does not typically involve the rigorous clinical study design, acceptance criteria, and performance metrics as might be seen for devices requiring a PMA (Premarket Approval) or for AI/ML-driven diagnostic devices.
Instead, the submission focuses on demonstrating equivalence through mechanical testing, material comparison, and similarities in indications for use and design features to predicate devices. Therefore, many of the requested categories for AI/ML device studies are not applicable here.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
This 510(k) summary for HA Coated Lag Screws does not define explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI tools. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices.
Acceptance Criteria for Substantial Equivalence (Implicit from the text):
The device is considered to meet acceptance criteria if it can demonstrate:
- Similar Indications for Use: The HA Coated Lag Screws address the same clinical uses as the predicate devices.
- Similar Design Features: The device's design is comparable to the predicate devices.
- Similar Operational Principles: The way the device functions is similar to the predicate devices.
- Similar Material Composition: The materials used (316L stainless steel or Titanium-6Al-4V) are comparable to those in predicate devices.
- Mechanical Equivalence: The device can withstand expected in vivo loading without failure, as indicated by mechanical test data, demonstrating it is "equivalent to devices currently used clinically."
Reported Device Performance:
The text states: "A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
| Acceptance Criteria (Derived) | Reported Device Performance |
|---|---|
| Similar Indications for Use | Confirmed (listed for Compression Hip Screw/IMHS Systems) |
| Similar Design Features | Confirmed (based on comparison to predicate devices) |
| Similar Operational Principles | Confirmed (based on comparison to predicate devices) |
| Similar Material Composition | Confirmed (316L SS or Ti-6Al-4V, comparable to predicates) |
| Mechanical Equivalence (withstanding in vivo load) | Confirmed ("capable of withstanding expected in vivo loading without failure") |
Details Regarding a Study for Device Performance (where applicable)
Given this is a 510(k) for a mechanical implant, the type of "study" is a mechanical test data review, not a clinical trial with human subjects in the way an AI diagnostic device would be evaluated.
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Sample Size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of screws or tests, but it refers to "mechanical test data." These tests are typically performed on a statistically relevant number of samples to ensure robust results, but the exact number isn't in the summary.
- Data Provenance: The data is from "mechanical test data," which would be conducted in a laboratory setting by the manufacturer (Smith & Nephew, Inc. Orthopaedic Division). There is no mention of country of origin of clinical data or retrospective/prospective nature, as this is pre-market mechanical testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for mechanical testing. "Ground truth" in this context would be the physical properties and performance measured against engineering specifications and industry standards, not expert clinical consensus. The experts involved would be engineers and materials scientists interpreting the mechanical test results.
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Adjudication method for the test set:
- Not applicable. Mechanical testing involves objective measurements rather than adjudication of interpretations.
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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 device is a mechanical implant, not an AI-driven diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.
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The type of ground truth used:
- The "ground truth" for mechanical equivalence is established through objective engineering measurements (e.g., strength, fatigue, torque, pullout force) against predefined specifications and industry standards for similar implant devices. The "equivalence" aspect also relies on comparison to the known mechanical performance of the predicate devices.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires training data.
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How the ground truth for the training set was established:
- Not applicable.
Summary of Inapplicability:
It's crucial to understand that the queries primarily relate to the evaluation of AI/ML diagnostic or assistive devices. The provided document concerns a 510(k) submission for a traditional mechanical medical implant (HA Coated Lag Screws). Therefore, most of the questions regarding AI-specific evaluation methodologies (like MRMC studies, ground truth for training/test sets in an AI context, expert readers, etc.) are not relevant to this particular device submission. The device demonstrates safety and effectiveness through mechanical testing and substantial equivalence to legally marketed predicate devices.
§ 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.