(29 days)
CAPTIVATE® Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.
CAPTIVATE® Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE® implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, and F138.
The provided document describes the FDA 510(k) clearance for Globus Medical Inc.'s CAPTIVATE® Compression Screws. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices through performance testing rather than a study involving human subjects or AI algorithms assessing medical images.
Therefore, many of the requested criteria (e.g., acceptance criteria for AI algorithms, sample size for test sets, expert ground truth, MRMC studies, training set details) are not applicable to this type of regulatory submission. The information provided heavily emphasizes the mechanical and material performance of the screws.
Here's an analysis of the provided information based on your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document describes performance testing to demonstrate substantial equivalence, rather than setting specific clinical acceptance criteria in terms of accuracy or sensitivity/specificity for an AI. The performance criteria are mechanical, comparing the new screws to existing predicates.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Torsion | Demonstrate equivalence to predicate devices (K162825, K140891, K190586) | Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary) |
| Insertion/Removal | Demonstrate equivalence to predicate devices | Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary) |
| Axial Pullout | Demonstrate equivalence to predicate devices | Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary) |
| Cantilever Bending | Demonstrate equivalence to predicate devices | Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary) |
| Biocompatibility | Materials meet applicable standards (ASTM F136, F1295, F1472, F1537, F138) or are used in 510(k) cleared devices. | Demonstrated by using materials meeting standards or previously cleared devices (K162825, K212433). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For mechanical testing, "sample size" would refer to the number of screws tested for each mechanical property. Data provenance would refer to the lab where the testing was conducted. This is typically found in the detailed test reports submitted to the FDA, not in the 510(k) summary.
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)
This is not applicable. The "ground truth" for a bone screw is its physical and mechanical properties, not an assessment made by human experts on an image or clinical case. The ground truth is established through standardized laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. As this is mechanical testing, there is no human "adjudication" in the sense of clinical agreement. Lab testing results are objective measurements.
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
This is not applicable. This document describes a medical device (bone screws), not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is established via standardized mechanical and material property testing according to ASTM standards (ASTM F543, ASTM F2193) and FDA guidance for orthopedic non-spinal metallic bone screws. This is objective laboratory-measured data, not clinical ground truth.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable.
Summary of Device Performance Study:
The study proving the device meets the (implied) acceptance criteria is a series of mechanical and biocompatibility tests performed according to recognized industry standards (ASTM) and FDA guidance.
- Test Performed: Static torsion, insertion/removal force, axial pullout strength, and cantilever bending strength. Biocompatibility was also assessed by confirming material compliance with standards and prior FDA clearances.
- Purpose: To demonstrate substantial equivalence of the CAPTIVATE® Compression Screws to legally marketed predicate devices (CAPTIVATE® Compression Screws K162825, Zimmer Biomet Cannulated Screw System K140891, Paragon 28 Monster® Screw System K190586).
- Result: The performance data supported the claim of substantial equivalence, indicating the device performs comparably to existing devices in terms of its mechanical properties and material safety.
In essence, this document is a regulatory submission for a physical medical device, and the "study" is a collection of engineering and material science tests, not
a clinical efficacy or AI performance study.
§ 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.