(29 days)
The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is intended for soft tissue repair of the shoulder; specifically, Bankhart and SLAP repair, and capsulolabral reconstruction.
The BioAnchor® with Disposable Driver, Preloaded with One #2 Herculine™ Suture is an injection molded PLLA suture anchor implant pre-loaded with a single strand of the absorbable suture, preloaded onto a disposable driver with a stainless steel shaft and ABS handle. The BioAnchor® is supplied sterile and single use. The modification described in this Special 510(K) is to replace the suture in the device with One #2 Herculine™ High Strength polyethylene non-absorbable suture.
The provided text is a 510(k) Summary of Safety and Effectiveness, which describes a medical device, its intended use, and its predicate device. This type of document is submitted to the FDA for market clearance and does not typically contain detailed information about acceptance criteria or specific study results proving device performance against such criteria. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or a full clinical study report.
Therefore, the requested information, specifically a table of acceptance criteria and reported device performance, sample sizes for test sets and training sets, details about ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness study results, cannot be extracted from the provided text.
Here's what can be inferred or stated based on the text:
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A table of acceptance criteria and the reported device performance: Not Applicable (N/A). The document states that the modification (changing the suture material) "does not affect the device's intended use, fundamental scientific technology or performance specifications." This implies that the device is expected to perform as well as its predicate, but no specific performance metrics or acceptance criteria are provided in the document.
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Sample size used for the test set and the data provenance: N/A. No specific test sets or study data are presented. The document relies on demonstrating substantial equivalence to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No primary study data requiring ground truth establishment is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No primary study data is described.
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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: N/A. This device is a suture anchor, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This device is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. No primary study data requiring ground truth is described.
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The sample size for the training set: N/A. This device is a physical medical implant, and the concept of a "training set" is not applicable in this context.
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How the ground truth for the training set was established: N/A. Not applicable given the nature of the device.
In summary: The provided 510(k) summary focuses on demonstrating that a modification to an existing device (BioAnchor® with Disposable Driver) – specifically, replacing the suture with Herculine™ High Strength polyethylene non-absorbable suture – does not alter its fundamental aspects or performance, and thus it remains substantially equivalent to its predicate. It does not provide the detailed performance study results or acceptance criteria typically found in, for example, a clinical trial report for a novel diagnostic device.
§ 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.