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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.

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Healix Anchor is indicated for use in the following: 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; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

The Healix Anchor is a non-absorbable threaded suture anchor manufactured of polyetheretherketone (PEEK) 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 tissue. The Healix Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

Here's an analysis of the provided text regarding the Healix Anchor, focusing on acceptance criteria and supporting studies:

Based on the provided document, the Healix Anchor is a medical device, and the submission is a 510(k) premarket notification. This type of submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, quantitative acceptance criteria through a clinical study.

Therefore, the information you've requested about acceptance criteria and supporting studies, particularly those involving human readers, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, is not present and not applicable in this context. The document focuses on demonstrating substantial equivalence through technological characteristics and existing performance and safety testing.

Here's a breakdown of what can be extracted from the document in relation to your questions, and where information is inherently missing due to the nature of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Missing Information (Not applicable or not typically found in this type of 510(k) summary for a physical medical device)

1. Sample size used for the test set and the data provenance: This device is a physical bone anchor, not an AI or diagnostic imaging device that uses "test sets" of data as understood in that context. The "testing" referred to is likely mechanical, biocompatibility, and sterilization testing, not performance on data sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, refers to expert-validated data. For a physical implant, "ground truth" might relate to mechanical strength or biocompatibility standards, and would be established through engineering and biological testing, not expert consensus on images or outcomes.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 implant, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As stated above, "ground truth" for a physical device would relate to engineering specifications and biocompatibility standards. The document implicitly states that "performance and safety testing" was conducted, but doesn't detail the specific methodologies or "ground truths" used beyond establishing substantial equivalence to predicates.
7. The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires training data.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves Acceptance:

The "study" referenced in this 510(k) summary is not a single clinical trial or a data-driven performance study in the way one might think of for an AI diagnostic device. Instead, it refers to a submission demonstrating substantial equivalence to previously legally marketed devices (the predicate devices: Mitek Spiralok Anchor, Arthrex Corkscrew FT Anchor, and Arthrex Biocorkscrew Anchor).

The proof of acceptance rests on the assertion that:

• The indications for use of the Healix Anchor are clearly defined and substantially similar to the predicate devices.
• The technological characteristics (materials, design, sizes, suture options) are similar enough to the predicate devices that they do not raise new questions of safety or effectiveness.
• Performance and safety testing (not detailed in this summary, but typical for these devices includes mechanical strength, fatigue, biocompatibility, and sterilization validation) has been conducted and demonstrates that the device is substantially equivalent to the predicate devices.

The FDA's decision to clear the device (as indicated in the letter from Mark N. Melkerson) signifies their agreement that the device has met the criteria for substantial equivalence under 21 CFR 888.3040, thereby allowing it to be marketed.

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The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament /Tendon Repair, Bunionectomy . .
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex PushLock™, previously cleared under 510(k) K051219, is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction. soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull

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

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex Families which are part of this expanded indications submission are as follows: Arthrex Bio-Corkscrew and Corkscrew Arthrex Bio-Corkscrew FT and Corkscrew FT Arthrex PushLock Arthrex Tak Family

These implants are comprised of titanium alloy, poly (L-lactide) or PLLA, poly (Llactide-Co-D, L-lactide) or PLDLA, and Polyaryletherketone or (PEEK). They are offered in several different shapes and sizes. They are offered sterile.

This 510(k) premarket notification is for an expanded indication for the Arthrex PushLock, Tak, and Corkscrew products. Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices for the new indications rather than establishing new acceptance criteria and conducting studies against them.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance for the Arthrex PushLock, Tak, and Corkscrew products in the provided 510(k) summary (K061863). This submission is for an expanded indication for already cleared devices. The acceptance criteria for these devices would have been established during their original 510(k) clearances (K003817, K003227, K043337, K050358 for Corkscrew; K051219 for PushLock; K971723, K000506, K050749 for Tak Family).

The current submission hinges on demonstrating substantial equivalence to existing predicate devices for the new indications of hip capsular repair and acetabular labral repair. The performance criteria for these new indications are implicitly met by showing equivalence to the predicate devices, which are already deemed safe and effective for similar uses.

The predicate device for the hip labral repair indication is identified as K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants. The performance of the Arthrex devices for these new indications would be considered acceptable if they are deemed substantially equivalent to the Smith & Nephew devices.

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

The provided document does not mention any sample sizes used for a test set or data provenance because this is a 510(k) submission for new indications based on substantial equivalence to predicate devices, not a de novo submission requiring extensive new clinical trial data. Instead, the focus is on comparing the characteristics of the Arthrex devices to the predicate devices, particularly for the new hip indications. This typically involves:

• Dimensional comparisons: Ensuring the sizes and designs are comparable.
• Material comparisons: Confirming the materials (titanium alloy, PLLA, PLDLA, PEEK) are acceptable and similar to the predicate.
• Mechanical testing data (if any was submitted): To demonstrate comparable strength, pull-out strength, or other relevant biomechanical properties for the intended use, although the document does not explicitly detail such testing for this particular submission.

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

Not applicable. As this is a substantial equivalence submission, there is no "test set" in the context of clinical studies requiring expert ground truth establishment for performance evaluation. The "ground truth" for the predicate devices' safety and effectiveness has already been established through their prior clearances and clinical use.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is mentioned.

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

Not applicable. This is not a study involving human readers or AI assistance. It's a regulatory submission for expanded indications of medical devices based on substantial equivalence.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is not a study of an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Smith & Nephew BioRaptor and TwinFix Ti implants for hip labral repair), as determined by their previous 510(k) clearances and accepted clinical performance. The Arthrex devices are being presented as having sufficiently similar characteristics and intended use to the predicates for the new indications.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no training set.

In summary, the provided document K061863 is a 510(k) premarket notification seeking clearance for expanded indications for existing Arthrex medical devices (suture anchors). It operates on the principle of "substantial equivalence" to predicate devices already on the market. Therefore, it does not involve the type of acceptance criteria, clinical studies, or data provenance usually associated with proving performance for novel devices or AI algorithms. The "proof" is the detailed comparison of the new indications' intended use and the device characteristics to those of the legally marketed predicate devices.

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