Search Results

The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.

The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.

The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Elbow: Ulnar/Medial Collateral Ligament Repair
• Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.

The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis.
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

The VersaTap™ Suture Anchor is a self-tapping suture anchor. This anchor is designed to combine the advantages of both PEEK and Titanium. The titanium tip makes the product self-tapping, whilst the majority of the anchor is manufactured from PEEK to minimize post-operative imaging effects.

The VersaPEEK™ Suture Anchor is manufactured completely from PEEK. This material composition minimizes post-operative imaging effects. The suture anchor is designed for ultimate mechanical properties (pullout strength, tensile strength, etc). The VersaPEEK™ Suture Anchor also has a variety of suture/suture tape configurations.

The MicroTiTM Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.

The VersaLat™ Ti Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

The VersaLat™ Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

The provided document is a 510(k) Premarket Notification from the FDA for several suture anchor devices (VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. It does not involve AI/ML technology, imaging, or human reader studies.

Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of an AI/ML study, "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are not applicable to this type of submission.

The study described here is a mechanical and biocompatibility assessment of medical devices, not an AI/ML performance study.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Study for Suture Anchors (Non-AI/ML Medical Device)

The provided submission, K242296, for the VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors, is a 510(k) Premarket Notification. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance of an AI/ML algorithm or derive clinical effectiveness from human reader studies.

The acceptance criteria and supporting studies are based on non-clinical testing to ensure the new devices are as safe and effective as their predicates.

1. Table of Acceptance Criteria (for Non-Clinical Testing) and Reported Device Performance

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

This is not an AI/ML study with a "test set" of data in the traditional sense. It's a medical device submission based on non-clinical bench testing and comparison to predicates.

• Sample Size:
  • For mechanical testing (insertion torque, static pullout), specific sample sizes would have been used per test standards (e.g., ASTM, ISO). These exact numbers are not detailed in the summary document but are implied to be sufficient for demonstrating equivalence.
  • For biocompatibility, the assessment relies on the prior clearance of the same materials and processes in predicate devices. New testing (e.g., non-pyrogenic) would involve a sample size relevant to that specific test.
• Data Provenance: The data provenance is from bench laboratory testing conducted by Ortho-Design (Pty) Ltd in South Africa. It is prospective testing of the new devices and comparison to the known performance and characteristics of the already cleared predicate devices.

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

• This is not applicable as this is not an AI/ML study involving human interpretation of data where "ground truth" is established by experts in an annotation or diagnostic capacity.
• The "ground truth" in this context is established by engineering and biocompatibility standards and the documented performance of legally marketed predicate devices, as determined by mechanical and chemical testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no human interpretation or diagnostic "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to AI/ML software where the aim is to evaluate how AI assistance impacts human reader performance (e.g., in medical imaging diagnosis). This submission pertains to physical medical devices (suture anchors) and their mechanical/biocompatibility characteristics.

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

• Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for these suture anchors is established through:

• Engineering Standards: Adherence to recognized national and international standards for mechanical testing of bone anchors (e.g., those referenced in the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions').
• Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (cleared in K212381), which serve as the benchmark for equivalence.
• Material Biocompatibility Data: Established safety profiles of the materials (PEEK, Titanium) as used in previously cleared medical devices, and specific biocompatibility testing (e.g., pyrogenicity) performed on the subject devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML study involving a "training set" of data.

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

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

Ask a specific question about this device

The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.

This document, a 510(k) premarket notification from the FDA, pertains to a medical device (KATOR Suture Anchor) and does not describe or contain information about a study proving that a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Instead, this document is a Traditional 510(k) approval for a physical medical device (suture anchor). The "tests" mentioned are nonclinical (mechanical) tests to ensure the device's physical performance, not diagnostic performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI/SaMD product based on this document. The document lists:

• Device Name: KATOR Suture Anchor
• Regulation Name: Smooth or threaded metallic bone fixation fastener
• Regulatory Class: Class II (physical device)
• Product Code: MBI (physical device)
• Predicate Device: Arthrex Corkscrew FT (K061665) - also a physical device.

The "Nonclinical Testing" section states:
"The device performance was characterized through the following tests:

• Static and Dynamic Performance
• Suture Knot Strength"

These are mechanical tests, not performance studies for a diagnostic AI.

To answer your request about acceptance criteria and a study for an AI/SaMD, I would need a document that describes the clinical performance evaluation of an AI or software device, typically involving a test set, ground truth establishment, and statistical analysis of diagnostic metrics. This document does not contain that information.

Ask a specific question about this device

The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder
Bankart lesion repairs SLAP lesion repairs Acromioclavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid repairs

Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Elbow
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar realignment and tendon repairs: Vastus medialis obliquous advancement

Hip Abductor tendon repair

The TWINFIX Ultra Ti suture anchor is manufactured from titanium, the TWINFIX Ultra PK suture anchor manufactured from polyetheretherketone grade LT3 and the TWINFIX Ultra HA suture anchor is manufactured from poly 1lactide/hydroxylapatite. All anchors are offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with suture, preassembled onto a stainless steel inserter and offered with and without needles.

The provided text describes an Indication Expansion for a medical device (TWINFIX Ultra Ti, PK, and HA suture anchors), seeking to add "Abductor tendon repair" to its intended uses. The submission focuses on demonstrating substantial equivalence to predicate devices and does not describe a study to establish new acceptance criteria or device performance for the new indication alone.

Instead, the submission states that:

• "The performance testing conducted includes static loading, dynamic loading and in vitro degradation properties that are substantially equivalent to the indicated predicates." (Section H)
• "Testing also demonstrates that the differences in the TWINFIX Ultra Ti, PK and HA families and the predicate devices do not raise any new issues of safety and efficacy." (Section H)
• "Since there are no changes to the design the technological characteristics remain the same." (Section G)

Therefore, the acceptance criteria are implicitly those established for the predicate devices and for general suture anchors, with the new indication being supported by demonstrating that the device's performance characteristics (static loading, dynamic loading, degradation properties) are equivalent to those already accepted for similar devices with similar indications. No new, specific acceptance criteria for "Abductor tendon repair" or a dedicated study for it are detailed.

Given this, I cannot fill the requested table or answer most of the questions about a new study proving devices meet acceptance criteria as such a study is not described in the provided text. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than presenting new performance study data for novel acceptance criteria.

However, I can extract the following relevant information based on the premise of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The rest of the questions relate to a specific study demonstrating device performance against new acceptance criteria. Since this document focuses on substantial equivalence to existing devices and does not describe such a study for the indication expansion, I cannot answer them from the given text.

To reiterate, the provided text is a 510(k) summary for an indication expansion, which relies on demonstrating that the performance of the device (TWINFIX Ultra Ti, PK, and HA suture anchors) for the new indication (Abductor tendon repair) is substantially equivalent to that of already legally marketed predicate devices. It does not describe a de novo study to establish new performance criteria or a new study with the details requested in points 2-9 for the expanded indication.

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

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.

Ask a specific question about this device