(90 days)
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
• Scaphoid Fractures
• Capitate
• Metacarpal Fractures
• Phalangeal Fractures
• Ulnar Styloid Fractures
• Small Joint Fusion
• Humeral head Fractures
• Intercarpal Fractures
• Tarsal Fusions
• Patellar Fractures
• Interfragmentary Ulnar Fractures
• Small Hand and Wrist Bone Fractures
• Forefoot Interfragmentary Fractures
• Lunate Fractures
• Trapezial Fractures
• Metatarsal Fractures
• Radial Head Fractures
• Osteo-Chondral
• Ostero-Chondral Fractures
• Glenoid Fractures
• Interphalangeal Fractures
• Malleolar Fractures
• Metaphyseal Fractures
• Interfragmentary Radius Fractures
• Distal Metatarsal Osteotomies
• Midfoot Interfragmentary Fractures
The Instratek Mini Cannulated Titanium Headed and Headless Screw Set is comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy. The screws have Torx heads. Instruments provided in the set include drivers (fixed and rotating) and blades, countersink/depth gauge, screw pickup, drill bits, threaded and unthreaded kwires and a caddy/tray.
The provided document is a 510(k) summary for the Instratek Mini Cannulated Titanium Headed and Headless Screw Set. It is a submission to the FDA for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information (related to AI acceptance criteria, study design, ground truth, expert adjudication, MRMC studies, and standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device itself and the regulatory submission.
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or performance metrics for the device itself (e.g., screw strength, biocompatibility). Instead, it's a regulatory submission demonstrating substantial equivalence to predicate devices. The "performance" in this context refers to the device being considered "as safe and effective" as legally marketed predicate devices.
| Acceptance Criteria Type | Reported Device Performance (as claimed in submission) |
|---|---|
| Safety and Effectiveness | The device is "as safe and effective as the legally marketed predicate devices." |
| Technological Characteristics | "The proposed device has the same technological characteristics as the predicate devices." |
| Intended Use | Matches the predicate devices (listed in the "Indications for Use" section). |
| Materials | "comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy." (Implicitly, comparable to predicate devices). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not Applicable. This document is a 510(k) summary for a physical medical device (bone screws), not a study evaluating an AI algorithm. Therefore, there is no "test set" in the context of an AI study, nor is there data provenance as described for algorithms.
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):
Not Applicable. As explained above, this is not an AI study. The "ground truth" for this device's safety and effectiveness is established through comparison to legally marketed predicate devices, which implicitly have a history of safe and effective use based on clinical practice and regulatory oversight. There are no specific experts mentioned for establishing "ground truth" in the context of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. This is not an AI study, so there is no adjudication method for a test set.
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 is not an AI algorithm, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed (and would not be relevant).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this 510(k) submission is based on substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices with a known history of safety and effectiveness, based on their design, materials, technological characteristics, and intended use. There's no specific "ground truth" in the sense of a definitive diagnosis or outcome used to evaluate an AI algorithm.
8. The sample size for the training set:
Not Applicable. This document does not describe the development or evaluation of an AI algorithm, so there is no training set mentioned.
9. How the ground truth for the training set was established:
Not Applicable. As there is no AI algorithm or training set, this question is not relevant to the provided text.
In summary, the provided text is a regulatory submission (510(k) summary) for a physical medical device (bone screws) to demonstrate substantial equivalence to predicate devices, not a study evaluating the performance of an AI algorithm. Therefore, most of the detailed questions about AI acceptance criteria, study design, and ground truth are not addressed by this document.
§ 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.