(167 days)
The Smith & Nephew Cannulated Captured Screw is intended for use for internal bone fixation including fractures of the tibia, fibula, clavicle, scapula, olecranon, metacarpals, metatarsals, humerus, ulna, middle hand bones, middle foot bones, and calcaneous. Screws are additionally intended for arthrodeses and osteotomies of small bones and small joints including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, clavicle, scapula, olecranon, ulnar styloid, radial head, and radial styloid.
The Smith & Nephew Cannulated Captured Screw is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of a titanium alloy or stainless steel fixation device. This device is provided sterile, for single use only.
Here's an analysis of the provided text regarding the Smith & Nephew Cannulated Captured Screw, focusing on acceptance criteria and the study conducted:
The provided documents describe a 510(k) premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials to establish new safety and efficacy data. Therefore, the "study" described herein is primarily mechanical testing to prove equivalence, not a clinical study involving human subjects or AI performance.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Insertion Torque | Meet or exceed performance of the predicate device. | "demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (implicitly meeting or exceeding predicate performance for substantial equivalence). |
| Pull-out Strength | Meet or exceed performance of the predicate device. | "demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (implicitly meeting or exceeding predicate performance for substantial equivalence). |
| Static Torsional Strength | Meet or exceed performance of the predicate device. | "demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (explicitly mentioning torsional capabilities). |
| Three-point Bend Fatigue | Meet or exceed performance of the predicate device. | "demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw" (implicitly meeting or exceeding predicate performance for substantial equivalence, ensuring durability under bending). |
| Overall Performance for Substantial Equivalence | Demonstrated to be substantially equivalent to the predicate device (Arthrex, Inc. Low Profile Screws, K103705) in intended use and fundamental scientific technology. | "it is considered substantially equivalent to the currently marketed predicate device." and "Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate device." |
Explanation of Implied Acceptance Criteria: For 510(k) submissions, the primary "acceptance criterion" for mechanical testing is that the new device performs at least as well as or is equivalent to the predicate device in relevant mechanical properties. The text explicitly states "demonstrates the device has met the performance specifications," which are understood to be established in comparison to the predicate.
Study Details (Mechanical Testing for Substantial Equivalence)
Given that this is a 510(k) for a traditional medical device, not an AI/software device, many of the requested items (sample size for test set, data provenance, number of experts for ground truth, MRMC study, AI performance) are not applicable. The "study" here refers to pre-clinical mechanical testing.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in the provided documents. Mechanical testing typically involves a set number of samples per test type (e.g., n=5 or n=10 per test) to ensure statistical significance, but the exact numbers are not detailed here.
- Data Provenance: The testing was conducted by Smith & Nephew, Inc. It's a prospective series of tests performed on newly manufactured devices. There's no geographical "data provenance" in the clinical sense, as it's laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This is pre-clinical mechanical testing, not a study requiring expert clinical interpretation for ground truth. "Ground truth" here is the empirically measured mechanical performance of both the new device and the predicate device. Engineers and materials scientists within Smith & Nephew would have designed and conducted these tests, comparing results to established standards and the predicate's performance.
4. Adjudication Method for the Test Set
- Not Applicable. Again, this is mechanical testing. Adjudication methods like "2+1" typically apply to clinical image interpretation or diagnostic performance where human disagreement needs resolution. The "adjudication" in this context would be the objective measurement against pre-defined test methodologies and comparison 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
- No. This is not an AI-assisted device; it is a physical bone fixation screw. Therefore, no MRMC study or AI-related performance metrics are relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- Empirical Mechanical Measurements: The ground truth for this mechanical testing is the objectively measured physical properties (insertion torque, pull-out strength, static torsional strength, three-point bend fatigue) of the Smith & Nephew Cannulated Captured Screw and, presumably, equivalent measurements of the predicate device. This data is compared against established performance specifications and the predicate's known performance.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of mechanical testing for a physical medical device. This term applies to machine learning models.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth for it.
§ 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.