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The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene suture. The Bio Mini-Revo suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions: with or without colorant D&C violet #2.

This document is a 510(k) summary for the ConMed Linvatec Bio Mini-Revo Suture Anchor. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a new, unique device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted because such a study is not described in this 510(k) submission.

Key points from the document that explain why the requested information isn't available:

• Type of Submission: This is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with defined acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The ConMed Linvatec Bio Mini-Revo Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K053561, K072291 and K061863."
• Lack of Performance Data: There are no sections detailing specific performance metrics, clinical study results, or statistical analyses against defined acceptance criteria that would typically be found in a study proving a device meets certain performance thresholds.
• Device Type: The device is a Bioabsorbable Suture Anchor. The 510(k) generally relies on the established safety and performance of similar predicate devices and material characterization (e.g., bioabsorption properties of the PLA Copolymer) rather than a comparative study of its clinical performance against specific metrics.

In summary, this 510(k) submission successfully established substantial equivalence, allowing the device to be marketed, but does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance) that would be provided for a device with a novel mechanism requiring such demonstration.

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The Bio Mini-Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open hip procedures; such as acetabular labral repair.

The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylone suture. The Bio Mini-Revo® suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.

ConMed Linvatec Bio Mini-Revo Suture Anchor A Acceptance Criteria and Study Details

The provided document is a 510(k) summary for the ConMed Linvatec Bio Mini-Revo Suture Anchor, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not clinical performance against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, nor does it include details about AI device performance.

The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (predicate device) in terms of intended use, design, materials, and technological characteristics. This typically involves comparative testing against the predicate device or established standards, rather than defining novel acceptance criteria for clinical performance and conducting a dedicated study to prove it.

Here's a breakdown of why the requested information is absent and what is available in the document:

Missing Information (and why it's not present in a 510(k) summary of this type):

• A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria for the device beyond demonstrating substantial equivalence. Performance is typically compared to the predicate, not against pre-defined, novel clinical metrics with acceptance thresholds.
• Sample size used for the test set and the data provenance: Clinical studies with specific test sets and data provenance (country, retrospective/prospective) are generally associated with PMA (Premarket Approval) applications or de novo classifications for novel devices, or for specific clinical claims, not a 510(k) for substantial equivalence of this type of device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no clinical "test set" in the context of an AI device or a novel clinical study for this 510(k), this information is not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
• 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: This document concerns a physical medical device (suture anchor), not an AI diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are not relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical "ground truth" establishment in this context. Substantial equivalence is demonstrated by comparing device characteristics, not clinical outcomes in a broad sense.
• The sample size for the training set: Not applicable, as this is not an AI device or a device involving machine learning.
• How the ground truth for the training set was established: Not applicable, as this is not an AI device or a device involving machine learning.

What the document does describe in terms of "proving" the device:

The document aims to prove substantial equivalence to predicate devices. This is achieved by comparing the new device (ConMed Linvatec Bio Mini-Revo Suture Anchor) to existing, legally marketed devices (ConMed Linvatec Bio Mini-Revo Suture Anchor K053561 and Arthrex Bio-FASTak Suture Anchor K061863) based on:

• Design: Bioabsorbable screw-in suture anchor, preloaded on a disposable inserter, with one nonabsorbable braided polyethylene suture.
• Manufacturing Materials: Self-Reinforced (96L/4D) PLA Copolymer.
• Intended Use: Reattach soft tissue to bone in arthroscopic or open hip procedures, such as acetabular labral repair.
• Principles of Operation: Similar mechanism of action for tissue reattachment.
• Technical Characteristics: Comparison of properties relevant to a suture anchor, such as material composition, dimensions (implied by "mini-revo" and comparison to similarly purposed predicates), and mechanical performance (though specific data is not provided in this summary, it would have been part of the full 510(k) submission).

The FDA's letter (Page 2-3) confirms their review of the 510(k) premarket notification and their determination that the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed.

In summary, the provided text describes a regulatory pathway (510(k)) that demonstrates substantial equivalence, not a clinical study proving performance against defined acceptance criteria by an AI or new medical device claiming novel functions.

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The Bio-Mini Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to secure soft tissue, such as ligaments, tendons, or joint capsules, to the bone, thereby stabilizing the damaged area during the healing period.

The Linvatec Bio-Mini-Revo™ suture anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with one non-absorbable, braided, ultrahigh molecular weight polyethylene suture. The Bio-Mini-Revo™ suture anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.

The requested information is not available in the provided document. The document is a 510(k) summary for a medical device (Bio-Mini Revo Suture Anchor) and primarily discusses its substantial equivalence to predicate devices, device description, and intended use. It does not contain details about specific acceptance criteria or a study proving the device meets them in the way described in the request (e.g., performance metrics, sample sizes, expert involvement, and ground truth establishment). The document is a regulatory submission for premarket notification, not a clinical or performance study report.

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