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Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The design enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.

The provided text describes a 510(k) premarket notification for a medical device called the Hitch™ LactoSorb® Suture Anchor. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and a device's performance against those criteria is measured using a test set with corresponding ground truth.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, and expert adjudication cannot be extracted from this document as it does not contain information about a clinical or standalone performance study.

Here's an attempt to address the points based on the provided text, heavily indicating when the information is not present:

1. A table of acceptance criteria and the reported device performance

Explanation: The document does not define specific, quantifiable acceptance criteria for the device's performance (e.g., a certain pull-out strength, a specific failure rate, or a particular clinical outcome threshold). Instead, the basis for approval is "substantial equivalence" to a legally marketed predicate device. The performance is reported as meeting this substantial equivalence through non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size used for the test set: Not applicable. No clinical or standalone device performance test set is described.
• Data provenance: Not applicable. The "Non-Clinical Testing" mentioned likely refers to bench-top or mechanical tests, not human data. No country of origin is specified for these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. No ground truth was established for a test set as no such clinical or performance study involving human data or expert assessment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is mentioned as there is no human-involved test set requiring expert consensus.

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

• No. This device is a suture anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and not mentioned.

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

• No. This device is an implantable medical device, not an algorithm. The "Non-Clinical Testing" could be considered a form of standalone performance assessment in a mechanical sense, but it's not "algorithm only" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For the non-clinical testing, the "ground truth" would likely be engineering specifications, material properties, and mechanical test standards, rather than clinical or expert-derived ground truth.

8. The sample size for the training set

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

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

• Not applicable. As there is no training set mentioned, no ground truth for it was established.

Summary:

The provided 510(k) summary is for a traditional medical device (a suture anchor) and primarily relies on demonstrating "substantial equivalence" to a predicate device through non-clinical laboratory testing. It does not involve AI, clinical studies with human participants, expert adjudication, or the establishment of ground truth in the manner that would be relevant for a diagnostic or AI-powered medical device. The information requested regarding acceptance criteria and study methodology is largely absent because the regulatory pathway chosen (510(k) for a device like this) typically focuses on comparative technological characteristics and function rather than detailed clinical performance studies with defined acceptance criteria for novel outcomes.

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Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.

The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.

The provided document is a 510(k) summary for the ALLthread™ LactoSorb® Suture Anchor. It details the device's characteristics and its substantial equivalence to a legally marketed predicate device. However, it explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."

This means that a study proving the device meets specific acceptance criteria based on clinical performance was not performed for this submission. The substantial equivalence was determined through non-clinical laboratory testing.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document.

If this were a document that included such a study, the information would typically be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: [Number of devices/tests]
• Data Provenance: [e.g., In vitro laboratory testing, Animal study in X species, etc. (Since clinical testing was not done, this would describe the non-clinical test set)].

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable for this type of submission. For clinical studies involving human interpretation or diagnosis, this would usually involve physicians, radiologists, or other specialists.

4. Adjudication Method for the Test Set:

• Not applicable for this type of submission. Adjudication is typically used in clinical trials involving human assessment to resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC study was not done. These are highly specific to AI/software performance studies involving human readers.

6. Standalone (Algorithm Only) Performance:

• No, standalone performance was not assessed. This is also specific to AI/software.

7. Type of Ground Truth Used:

• For this submission, the "ground truth" for non-clinical testing would be the established scientific and engineering principles and standards used to evaluate the device's physical and mechanical properties, as well as its biocompatibility. For instance, tensile strength measurements have an objective "ground truth" based on physics.

8. Sample Size for the Training Set:

• Not applicable. This relates to machine learning models, which are not described in this submission.

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

• Not applicable. This also relates to machine learning models.

In summary, based on the provided text, the ALLthread™ LactoSorb® Suture Anchor received its 510(k) clearance based on non-clinical laboratory testing demonstrating substantial equivalence to a predicate device, without the need for clinical testing or establishing specific clinical acceptance criteria.

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Ask a specific question about this device