(89 days)
The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. fragments of nuctured non load beaning of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
The Arthrotek® LactoNail™ bioabsorbable bone fixation nail is constructed of a resorbable copolymer composed of PLLA/ PGA. The device is available in 1.6, 2.0, and 2.6mm diameters. The LactoNail™ comes in four (4) lengths (14, 18, 110/ 210/ 210/ and 26mm). Arthrotek® LactoNail™ maintains alignment of small bone fractures and apical fragments, osteochondral fragments and cancellous/non-load bearing fragments following arthroscopy or open surgery.
The provided text describes a 510(k) premarket notification for the "Arthrotek® LactoNail™" bioabsorbable bone fixation nail. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, and expert review is not present in the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate SmartPin™ (K925098) | "The testing demonstrates that the Arthrotek® LactoNail™ is substantially equivalent to the predicate." |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance test set data is provided in the document. The testing was mechanical and comparative to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review was utilized for this type of test (mechanical equivalence).
4. Adjudication method for the test set: Not applicable. No adjudication method described as this relates to expert review, which was not performed.
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 document is not about AI-assisted diagnosis or a multi-reader study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
For the mechanical testing, the "ground truth" was the mechanical performance of the predicate device, SmartPin™ (K925098). The new device's performance was compared against the known characteristics of the predicate to establish substantial equivalence.
8. The sample size for the training set: Not applicable. This is a medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. (See point 8).
Summary of Study (Mechanical Testing):
The only "study" mentioned is non-clinical mechanical testing.
- Objective: To demonstrate that the Arthrotek® LactoNail™ is substantially equivalent in mechanical performance to the predicate device, SmartPin™ (K925098).
- Methodology: Mechanical testing was performed on the Arthrotek® LactoNail™ (specifically mentioning "600mg 100." - likely referring to a test condition or sample size, but not detailed). The results were then compared to the predicate device.
- Conclusion: The mechanical testing demonstrated substantial equivalence to the predicate device.
- Clinical Testing: "Clinical testing was not required for this product." This indicates that the regulatory pathway for this device, due to its similarity to an already marketed predicate, did not necessitate human clinical trials to prove safety and effectiveness. The substantial equivalence argument was based on material, function, labeling, sizing, and mechanical performance.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.