(240 days)
The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.
The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.
This document is a 510(k) premarket notification for a medical device called the "Sniper Staple System." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI/MRMC studies is not applicable to this type of document.
However, I can extract the relevant information from the document in the context of a traditional medical device (a surgical staple).
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a surgical staple, "acceptance criteria" are typically defined by recognized standards and mechanical testing rather than a numerical performance metric like sensitivity/specificity for an AI. The document describes several non-clinical tests performed.
| Test Performed | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Four-point Bending (ASTM F564) | Meets performance requirements of ASTM F564 for fixation devices | Results indicate equivalence to predicate devices (Implied satisfactory performance) |
| Pull-out Testing (ASTM F564) | Meets performance requirements of ASTM F564 for fixation devices | Results indicate equivalence to predicate devices (Implied satisfactory performance) |
| Bend and Free Recovery (ASTM F2082) | Meets performance requirements of ASTM F2082 for Nitinol | Results indicate equivalence to predicate devices (Implied satisfactory performance) |
| Corrosion testing (ASTM F2129) | Meets performance requirements of ASTM F2129 for surgical implants | Results indicate equivalence to predicate devices (Implied satisfactory performance) |
| Pyrogenicity (LAL assay) | Recommended maximum endotoxin level of 20 EU per device | Demonstrated that the subject device meets the recommended maximum endotoxin level. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the specific ASTM standards referenced (e.g., F564, F2082, F2129).
- Data Provenance: Not applicable. These are laboratory-based mechanical and biological (pyrogenicity) tests performed on the device itself, not data from human subjects or clinical records.
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. Ground truth as typically understood for AI/diagnostic algorithms is not relevant here. The "truth" is established by the physical properties and performance of the device as measured by standardized engineering and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to human review of medical data for ground truth establishment, which is not relevant for this device's testing.
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 a traditional surgical staple, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical tests: Engineering standards (ASTM F564, F2082, F2129) define acceptable performance.
- For biocompatibility/safety test: Biological standards (e.g., maximum endotoxin level for pyrogenicity).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary from the document for the Sniper Staple System:
The device's substantial equivalence to predicate devices is based on non-clinical testing, including:
- Four-point Bending (ASTM F564)
- Pull-out Testing (ASTM F564)
- Bend and Free Recovery Testing (ASTM F2082)
- Corrosion testing (ASTM F2129)
- Pyrogenicity testing (Limulus amebocyte lysate (LAL) assay)
The document states, "The results of these evaluations indicate that the Sniper Staple is equivalent to predicate devices," and for pyrogenicity, "The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device." No clinical studies were performed. The conclusion for equivalence is based on similarities in principles of operation, technology, materials, and indications for use.
§ 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.