(124 days)
The Trilliant 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 System consists of different-sized staples composed of Nitinol (Nickel-Titanium alloy) intended for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device. The system will be offered non-sterile in a tray for sterilization at the user's facility prior to use.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested. It's important to note that this document describes a medical device (bone staple), not an AI/algorithm-based device. Therefore, many of the requested fields pertinent to AI (like human reader improvement with AI assistance, training set details, or ground truth for AI) will not be applicable.
1. A table of acceptance criteria and the reported device performance
For a medical device like the Sniper Staple System, acceptance criteria are typically demonstrated through performance testing against established consensus standards.
| Acceptance Criteria (Measured against ASTM Standards) | Reported Device Performance (as stated in the summary) |
|---|---|
| Elastic Static Bending Strength: Meets ASTM F564-10 (2015), Annex IV - Test Method for Elastic Static Bending of Metallic Bone Staples. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate) |
| Pull-Out Fixation Strength: Meets ASTM F564-10 (2015), Annex II - Test Method for Pull-Out Fixation Strength of Metallic Bone Staples. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate) |
| Transformation Temperature: Meets ASTM F2082 (2016), Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate, ensuring the Nitinol material behaves as expected for its intended function, specifically its superelastic/shape memory properties relevant to bone fixation) |
| Corrosion Resistance: Meets ASTM F2129 (2017), Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. | "The results of these evaluations indicate that the Sniper Staples are safe and equivalent to the predicate device." (Implies compliance with the standard such that it is equivalent to the predicate, ensuring the material is suitable for long-term implantation without detrimental corrosion) |
| Biocompatibility: Demonstrated acceptable biocompatibility (referenced against other Trilliant Surgical K-numbers). | Demonstrated through cross-reference to prior 510(k) submissions for similar devices and materials (Nitinol) from Trilliant Surgical (K081510, K121452, K153338, and K123926 for Metasurg Nitinol Staple by Metasurg, indicating proven material safety in vivo). This indicates that the materials used in the Sniper Staple System are widely accepted as biocompatible for medical implant use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of staples or test specimens used for each non-clinical test (elastic static bending, pull-out, transformation temperature, corrosion resistance). It only states that "The following tests were performed."
- Data Provenance: Not applicable as these are non-clinical (laboratory/bench) tests on manufactured device samples, not patient data.
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. For non-clinical performance testing of a physical medical device, "ground truth" is established by adherence to recognized engineering and material science standards (ASTM in this case), and the results are quantified through laboratory measurements. Expert opinions in the context of clinical interpretation are not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies or image interpretation tasks where there's variability in human assessment. These are objective engineering tests.
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 a physical bone staple device, not an AI/imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical bone staple device, not an algorithm. The "standalone" performance here refers to the device's material and mechanical properties as tested against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is defined by the objective pass/fail criteria and quantitative measurements specified within the referenced ASTM (American Society for Testing and Materials) standards. These standards prescribe specific methodologies, acceptable ranges, and performance benchmarks for metallic bone staples and Nitinol materials.
8. The sample size for the training set
Not applicable. This refers to a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This refers to a physical medical device, not a machine learning model.
§ 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.