Search Results

The HEALIX TiTM Anchors with DYNACORD™ is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction:

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, Acetabular Labral Repair.

The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

This document is a 510(k) premarket notification for a medical device called the HEALIX Ti™ ANCHOR with DYNACORD™. It establishes substantial equivalence to a predicate device, meaning it does not require a new study to prove its safety and effectiveness in the same way a novel device would. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not applicable here.

The provided text focuses on the non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate, rather than a clinical study evaluating the performance of an AI/SaMD.

Here's an analysis based on the provided document:

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

The document describes non-clinical testing, not performance against specific clinical acceptance criteria of an AI/SaMD. The "acceptance criteria" here relate to engineering and material performance for a physical implant.

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

• Sample Size: Not specified in terms of number of anchors tested, but general non-clinical testing was conducted.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. This refers to lab-based testing of physical properties.

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

• Not applicable as this is not an AI/SaMD and does not involve human expert labeling of data. The "ground truth" for these tests would be the established engineering and materials science standards.

4. Adjudication method for the test set:

• Not applicable for non-clinical engineering tests.

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 a physical medical device, not an AI/SaMD.

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

• Not applicable. This is a physical medical device, not an AI/SaMD.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is defined by established engineering standards, USP specifications for suture materials, and biological safety standards (e.g., ISO standards for biocompatibility, endotoxin limits).

8. The sample size for the training set:

• Not applicable. This is not an AI/SaMD.

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

• Not applicable. This is not an AI/SaMD.

In summary, the provided document is a regulatory submission for a physical medical device (suture anchor) based on demonstrating substantial equivalence to an existing predicate device through non-clinical performance and safety testing, not through clinical trials or evaluations of an AI/SaMD.

Ask a specific question about this device

The Healix Ti Anchor is intended for:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

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

The document mentions "Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." However, it does not provide any details regarding the sample size used for these tests, nor the data provenance (country of origin, retrospective or prospective). Given the nature of a 510(k) summary, these granular details are often found in the full submission, not the publicly available summary.

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

This type of information is not applicable to this document. The device in question is a medical implant (suture anchor), not an AI or diagnostic device that requires expert review for ground truth establishment. The "ground truth" for this device would be its physical and mechanical performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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

This is not applicable as the device is a medical implant, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and mechanical testing data, primarily "pull out testing" to demonstrate its fixation strength in bone. It also relies on the established performance and safety record of its predicate devices.

8. The Sample Size for the Training Set

This is not applicable as the device is hardware (medical implant) and not an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as the device is hardware and does not have a training set or associated ground truth in the context of machine learning.

Ask a specific question about this device

Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair and secondary fixation in ACL / PCL reconstruction repair. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

The Healix Ti Anchor is a non-absorbable threaded suture anchor manufactured of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through The Healix Anchors are currently offered with absorbable tissue. Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

The provided text is a 510(k) summary for the Healix Ti Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or performance testing that would generate the kind of data requested in your prompt. This type of submission relies on comparisons to already approved devices.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size, ground truth, MRMC study, training set information) are not applicable or available within this document.

Here's an assessment based on the provided text:

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

• Not applicable / Not provided. The 510(k) summary states, "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." It does not list specific acceptance criteria (e.g., pull-out strength, fatigue life) or provide quantitative performance data for such criteria directly within this document. The "tests" performed are implicit in demonstrating substantial equivalence, likely through mechanical bench testing, but the details are not given here.

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

• Not applicable / Not provided. No specific 'test set' in the context of clinical or performance data is described in this summary. The substantial equivalence argument relies on comparison to predicate devices and likely bench testing, not a clinical test set.

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 / Not provided. Ground truth, in the context of expert consensus or clinical outcomes, is not relevant to this 510(k) submission, which is for a mechanical bone anchor and focused on substantial equivalence to existing devices.

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

• Not applicable / Not provided. Adjudication methods are typically for clinical studies or image interpretation, which are not detailed here.

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 mechanical bone anchor, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

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

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

• Not applicable / Not provided. Ground truth in the sense of clinical outcomes or expert labels is not part of this 510(k) summary for a mechanical device. The "ground truth" for substantial equivalence for such a device is typically established through a combination of engineering analysis, material properties testing, and mechanical performance tests (e.g., pull-out strength, fatigue) compared against the predicate devices. These specific tests and their "ground truth" values (e.g., meeting a certain strength threshold) are not detailed in this high-level summary.

8. The sample size for the training set

• Not applicable. This document describes a mechanical medical device, not a machine learning model, so there is no 'training set'.

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

• Not applicable. As above, there is no training set for this type of device.

Summary based on the document:

The provided document is a 510(k) summary for the Healix Ti Anchor. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present performance data against specific acceptance criteria from a primary clinical study. The "study that proves the device meets the acceptance criteria" is implicitly the "performance and safety testing" mentioned, but the details of these tests, specific criteria, and quantitative results are not included in this summary. Such details would typically be found in the comprehensive 510(k) submission itself, but not in this summary section.

Ask a specific question about this device