(266 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25-L All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.
TS 25-L is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill guide are made of stainless steel; and drill guide obturator is made of polypropylene.
The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use.
The provided text is a 510(k) summary for a medical device called OTS 25-L, a non-absorbable suture anchor. This submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proof specifically for the OTS 25-L's performance against predefined acceptance criteria for a novel AI device.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria is largely not present in the provided document, as it outlines a comparison to predicate devices, not a de novo evaluation against novel performance benchmarks.
The document discusses performance data for the OTS 25-L, but this data is used to demonstrate equivalence to predicate devices, not to meet specific, pre-defined acceptance criteria for a new type of performance characteristic.
Here's a breakdown of what can be extracted or inferred, and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics and thresholds for the OTS 25-L device. Instead, it aims to demonstrate that its performance is equivalent to that of predicate devices.
| Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Mechanical performance for insertion, pullout, and cyclic loading equivalent to predicate devices (OTS 25 and Y-Knot All-Suture Anchor). | OTS 25-L was tested for insertion, pullout, and cyclic loading on bone substitute. The conclusion was that it performs at least as well as the legally marketed predicate devices. |
| Biocompatibility and Sterilization Safety equivalent to predicate devices. | Concentration of sterilization residuals and bioburden testing performed; device remained within acceptable limits. No new biocompatibility testing performed as there were no new materials or manufacturing methods. |
Missing Information Regarding a Study Proving Acceptance Criteria
The following points are mostly not applicable or not detailed in the provided 510(k) summary because it's an equivalence submission, not a study to establish novel performance criteria for an AI or diagnostic device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "OTS 25-L was tested for insertion, pullout, as well as for cyclic loading, on bone substitute and compared to the predicate devices." No details on the sample size (number of anchors tested, number of bone substitute samples), or the provenance (e.g., in-vitro lab conditions, type of bone substitute) are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This question is usually for diagnostic devices where human expert consensus establishes a "ground truth" for diagnosis. For a mechanical device like a suture anchor, "ground truth" typically refers to physical measurements and material properties, not expert interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for expert reviews or clinical trials, not typically for mechanical testing of a device's physical properties.
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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 or diagnostic tool that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated, but implied as physical measurements/mechanical properties. For the mechanical tests (insertion, pullout, cyclic loading), the "ground truth" would be the objective measurements obtained from standardized testing methods.
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The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is a mechanical device, not an AI/machine learning model.
§ 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.