(55 days)
The Stealth Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- Arthrodesis in hand or foot surgery ●
- Mono or bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand ●
- . Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc. .
The Stealth Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
This document is a 510(k) premarket notification for the "Stealth Staple System," a metallic bone fixation appliance. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and nonclinical testing.
This document DOES NOT describe an AI/ML device or a study involving human readers and AI assistance. Therefore, I am unable to answer questions 2, 3, 4, 5, 6, 7, 8, and 9. These questions are specifically designed for AI/ML device submissions, which incorporate data provenance, expert ground truth, multi-reader studies, and training/test set details.
However, I can provide information based on the nonclinical testing described in the document for the "Stealth Staple System."
1. A table of acceptance criteria and the reported device performance:
The document states: "The results of this testing demonstrate that the Stealth Staple System met the predetermined acceptance criteria." However, specific numerical acceptance criteria and the corresponding reported performance values are not provided in this document. The document only lists the types of tests performed.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Testing | Not specified in the document | Met predetermined acceptance criteria |
| Fatigue Testing | Not specified in the document | Met predetermined acceptance criteria |
| Pullout Testing | Not specified in the document | Met predetermined acceptance criteria |
Explanation: The document mentions that the nonclinical testing (Static Testing, Fatigue Testing, Pullout Testing) was performed using the "same methods performed on the predicate device in submission K153622." It concludes that the device "met the predetermined acceptance criteria." However, it does not disclose what those predetermined acceptance criteria were (e.g., minimum load for static testing, cycles for fatigue testing, or force for pullout testing), nor does it disclose the actual numerical results achieved by the Stealth Staple System in these tests.
Summary for AI/ML Specific Questions (not applicable to this document):
- 2. Sample sized used for the test set and the data provenance: Not applicable. This is a medical device, not an AI/ML diagnostic.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.