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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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(120 days)
The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
The Minimally Invasive Bunion Plating System consists of left and right plates composed of implant grade titanium intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The system will incorporate both locking and non-locking screws, cannulated screws, and the necessary instruments to facilitate the placement of these implants.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the "Minimally Invasive Bunion Plating System". It aims to establish substantial equivalence to a legally marketed predicate device, not to prove the device meets specific acceptance criteria through a study demonstrating performance.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document for the following reasons:
- No Acceptance Criteria or Performance Study: This document does not describe acceptance criteria related to a specific performance study (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the device's function in terms of an AI/algorithm. This is a traditional medical device (bunion plating system), not an AI/algorithm device. The "acceptance criteria" here are the FDA's regulatory criteria for market clearance (substantial equivalence), not performance metrics against a clinical ground truth.
- No Clinical Study Performed: The document explicitly states under Section V. "Clinical Test Summary": "No clinical studies were performed." This means there is no study data to report for points 1, 5, 6, 7, 8, or 9.
- Focus on Substantial Equivalence: The entire submission is built on demonstrating substantial equivalence to a predicate device based on similarities in intended use, design, materials, and mechanical safety/performance, supported by non-clinical (mechanical) testing. It does not involve a study of an AI/algorithm's performance against a human expert's assessment or a defined ground truth.
Therefore, I cannot populate the requested table or answer the specific questions about AI/algorithm performance studies. The information provided is for a physical medical device (bone plates and screws), not a software/AI device.
The "Non-Clinical Test Summary" section mentions:
- Non-Clinical Test Summary:
- Single Cycle Bend Testing referencing ASTM F382
- Dynamic Bend Testing referencing ASTM F382
- "The results of these evaluations indicate that the Minimally Invasive Bunion Plating System is equivalent to the predicate devices."
This is the extent of "testing" mentioned, and it pertains to mechanical properties, not an AI's diagnostic or predictive performance.
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(92 days)
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
The provided text describes a physical medical device (Gridlock Plating System), not an AI/software device. Therefore, the questions related to AI/software performance criteria, ground truth, expert consensus, and multi-reader studies are not applicable.
This 510(k) submission is for a Special 510(k), meaning it's for a modification to a previously cleared device (Gridlock Plating System, K121452). The change from the predicate is the addition of two specific plates for the first metatarsal phalangeal joint. The submission aims to demonstrate substantial equivalence to the predicate device.
Here's the relevant information based on the provided text, modified to address the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria were based on substantial equivalence to predicate devices, particularly regarding mechanical performance.
| Acceptance Criteria Category | Specific Test / Standard | Performance Goal | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static compression testing | Equivalent to predicate devices | The results of this testing indicate that the current Gridlock Plating System is equivalent to predicate devices. |
| Mechanical Performance | Dynamic compression testing per ASTM F382-99, Annexes 1 and 2 | Equivalent to predicate devices | The results of this testing indicate that the current Gridlock Plating System is equivalent to predicate devices. |
| Materials | CP Titanium per ASTM F67 | Same as predicate devices | Manufactured from the same material. |
| Materials | Titanium alloy per ASTM F136 | Same as predicate devices | Manufactured from the same material. |
| General Design | Features (low profile, limited contact, dynamic/manual compression, angulated-locking threaded screw holes) | Same as predicate devices | Systems are similar in principles of operation, technology, and indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. For mechanical testing, the number of samples tested per condition is not provided.
- Data Provenance: The mechanical testing was performed in a laboratory setting. There is no mention of data from human subjects or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a physical medical device proving mechanical equivalence, "ground truth" related to expert assessment of data is not relevant. The relevant "experts" would be engineering/materials scientists conducting and interpreting the mechanical tests according to standards.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert assessment of clinical data, which is not relevant here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. No clinical studies were performed. This submission relies on mechanical testing and substantial equivalence to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance demonstration is based on established engineering standards (ASTM F382-99) and comparison against the known performance of legally marketed predicate devices. In essence, the "truth" is that the new plates perform mechanically equivalently to the previously cleared plates.
8. The Sample Size for the Training Set
Not Applicable. No training set for an algorithm is involved.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No training set for an algorithm is involved.
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