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510(k) Data Aggregation
(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.
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(56 days)
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants. The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).
This document is a 510(k) premarket notification for the "Tiger Cannulated Screw System". It primarily discusses the substantial equivalence of this device to previously marketed predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria in a clinical or AI-related context.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI-specific study details, ground truth, expert involvement, and sample sizes for training/test sets are not applicable to this document as it pertains to a traditional medical device (bone screws) and not an AI/ML device.
However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serve as the "acceptance criteria" for this type of submission.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from Non-clinical Test Summary) | Reported Device Performance |
|---|---|
| ASTM F543-07 requirements for: | The results of these evaluations indicate that the Tiger Cannulated Screws are equivalent to predicate devices. |
| - Torque to Failure | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Axial Pullout Strength | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Axial Pull Through Strength | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Driving/Insertion and Removal Torque | (Implicitly met standards of predicate devices / ASTM F543-07) |
| Conclusion of Equivalence: | The Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screws and Washers are equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. |
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 for this type of device. The non-clinical tests (ASTM F543-07) involve mechanical testing of the screws, not data from human patients or a test set in the AI sense. The number of screws tested for each mechanical property would typically be specified in the full test report, but it's not detailed in this 510(k) summary.
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. This submission relies on engineering and material standards for mechanical properties rather than expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert labeling of AI datasets, which is not relevant here.
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 mechanical device, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" or reference standard would be the defined specifications and performance characteristics of the predicate devices and the requirements of the ASTM F543-07 standard.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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