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The SpeedLock Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot

reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedLock Knotless Fixation System is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of soft tissue to bone.

The SpeedLock consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter, which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized. Both the anchor and inserter are designed for single use only.

The SpeedLock System also includes associated instruments for implanting the anchor into bone.

The design modifications include aligning the shape and size of the windows at the distal end of the anchor and adding a flat surface to the internal crossbar against which the anchor plug may rest once deployed. The modifications do not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the devices cleared indications for use.

The provided text is a 510(k) summary for the ArthroCare® Corporation SpeedLock® Knotless Fixation System. This document outlines a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for a diagnostic AI algorithm.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission, as it concerns a physical bone fixation device, not a diagnostic AI or software.

However, I can extract information related to product performance and testing where available.

Acceptance Criteria and Device Performance (ArthroCare® Corporation SpeedLock® Knotless Fixation System)

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study referenced is a Design Verification testing program.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified quantitatively in the document. The testing involved "Insertion strength and pull-out strength testing."
• Data Provenance: The testing was conducted in a simulated bone substrate. This indicates a bench-top, in-vitro (non-human/animal) lab setting. The country of origin for the data is not specified but implicitly refers to the testing performed by ArthroCare Corporation.
• Retrospective/Prospective: Not applicable, as this was laboratory testing of a physical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This submission is for a physical medical device (bone anchor) and its performance in mechanical tests, not a diagnostic AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No. This is a hardware device; MRMC studies are relevant for software/AI interpretation where human readers are involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a hardware device; "standalone performance" generally refers to AI algorithm performance without human intervention. The testing described is of the physical device itself.

7. The type of ground truth used:

• For the mechanical tests (insertion strength, pull-out strength), the "ground truth" would be the measured mechanical properties against pre-defined engineering specifications or performance standards. The document refers to "design, performance, and safety specifications."

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not Applicable. This is not an AI/machine learning device.

Summary of the Study:

The study involved Design Verification testing for the modified SpeedLock® Knotless Fixation System. This testing specifically included:

• Evaluation to demonstrate that the modifications did not alter the device's intended use or performance.
• Insertion strength testing in a simulated bone substrate.
• Pull-out strength testing in a simulated bone substrate.

The purpose of these tests was to demonstrate that the modified device continues to meet its pre-established design, performance, and safety specifications and that its mechanical properties remain substantially equivalent to its predicate device. The submission states that "All testing demonstrates that the modified SpeedLock Knotless Fixation System performs as intended and mechanical properties are substantially equivalent when used in accordance with its labeling." No clinical or animal data were included in this submission, indicating reliance solely on non-clinical, bench-top testing.

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The SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The SpeedLock Knotless Fixation Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedLock Knotless Fixation System. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting.

Therefore, many of the requested details, such as acceptance criteria in terms of accuracy, sensitivity, or specificity, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets, are not applicable to this type of regulatory submission. This document is primarily about demonstrating that a modified medical device is as safe and effective as a previously cleared device through an engineering and materials comparison.

Here's a breakdown of the available information with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in terms of distinct "cases" or "samples" as would be relevant for a diagnostic or AI device study. The comparison was described as "side-by-side bench testing," which implies physical testing of the device itself and its predicate.
• Data Provenance: Not explicitly stated, however, "bench testing" typically occurs in a laboratory setting, not derived from patient data. It is a prospective test conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. The "ground truth" for this type of device comparison is established through engineering specifications, material properties, and mechanical performance tests, not expert clinical assessment of diagnostic output.

4. Adjudication Method for the Test Set:

• Not applicable. This was a direct comparison of physical device characteristics and performance, not a review of clinical or diagnostic outcomes requiring adjudication.

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 not a diagnostic device involving human readers or AI assistance. It is a surgical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence for this device is based on engineering specifications, material compatibility, and mechanical performance standards outlined in the FDA Guidance Document for Testing Bone Anchors.

8. The Sample Size for the Training Set:

• Not applicable. This device does not utilize a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

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The Opus SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

The Opus SpeedLock Knotless Fixation Device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

The provided text is a 510(k) summary for the Opus SpeedLock Knotless Fixation Device. It asserts substantial equivalence to a predicate device (Opus LabraLock P Knotless Fixation Device, K061349). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the submission focuses on:

• Description of the new device and its intended use.
• Identification of an existing predicate device the new device is substantially equivalent to.
• A statement of substantial equivalence, asserting that the differences do not raise new questions of safety or effectiveness.
• Regulatory information such as classification, product code, and contact details.

Therefore, I cannot populate the table or answer most of your detailed questions because the necessary information about performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement is not present in the provided document. The 510(k) process for this type of device typically relies on demonstrating equivalence to a legally marketed predicate, rather than extensive de novo clinical studies with specific performance metrics.

Here's what I can extract based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: Not specified. The submission relies on substantial equivalence to a predicate device, implying that the safety and effectiveness are inferred from the predicate's known performance, rather than new performance data specific to the Opus SpeedLock device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new test set or ground truth establishment is described in this 510(k) summary.

4. Adjudication method for the test set:

• Not applicable. No new test set or adjudication process is described.

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 device is a bone anchor, not an AI-assisted diagnostic tool or imaging device that would involve human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a bone anchor, not an algorithm.

7. The type of ground truth used:

• Not applicable. No new ground truth is described. The basis for clearance is substantial equivalence to a predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI device, and no training set is mentioned.

9. How the ground truth for the training set was established:

• Not applicable.

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