(83 days)
The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.
The Instratek STAPIX™ Superelastic Implant Bone Staples kits are comprised of superelastic bone staples in 16 configurations. The Nitinol staples have a finished A(f) temperature of 10°C +/7° to ensure that the material is superelastic at room and body temperatures. The Instratek STAPIX™ Superelastic Implant is indicated for use in the treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon. The device is intended for hand and foot surgery. STAPIX™ bone staples are made from superelastic nickel titanium that does not require cold storage or heating. Implant sizes range from 9mm to 24mm.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the STAPIX™ Superelastic Implant Bone Staples:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on comparison to predicate devices and performance testing to demonstrate substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bending Fatigue | Similar or equivalent to predicate devices | Performance testing consisted of bending fatigue. (Results not detailed, but concluded to be safe and effective as predicate) |
| Static Bending | Similar or equivalent to predicate devices | Performance testing consisted of static bending. (Results not detailed, but concluded to be safe and effective as predicate) |
| Corrosion | Similar or equivalent to predicate devices / Biocompatible | Performance testing consisted of corrosion. (Results not detailed, but concluded to be safe and effective as predicate) |
| Material Properties | Superelastic at room and body temperatures (A(f) temperature) | Finished A(f) temperature of 10°C +/-7° to ensure superelasticity at room and body temperatures. |
| Intended Use | Treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon; hand & foot surgery. | Indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet. (Consistent with stated intended use) |
| Technological Characteristics | Same as predicate devices | The proposed device has the same technological characteristics as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The summary only mentions "performance testing consisted of bending fatigue, static bending, and corrosion." This implies in vitro mechanical testing, not a clinical test set with human subjects.
- Data Provenance: Not applicable for in vitro mechanical testing. There is no mention of country of origin or whether the data is retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the provided documentation describes in vitro mechanical testing and a comparison to predicate devices for substantial equivalence, not a clinical study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
- This information is not applicable as the provided documentation describes in vitro mechanical testing, not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technological characteristics and in vitro performance testing compared to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a bone staple. It is not an algorithmic or AI-based device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through physical and mechanical testing standards (for bending fatigue, static bending, and corrosion) and material science properties (like the A(f) temperature of Nitinol). The comparison point ("truth") for regulatory approval is the performance and characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware medical device (bone staple), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is a bone staple, there is no training set or associated ground truth establishment in the context of AI/ML.
§ 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.