Search Results

The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

The FOOTPRINT Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone). The tap-in anchor incorporates an anchor and plug and is pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.

This document describes a 510(k) premarket notification for the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, a medical device for reattaching soft tissue to bone. However, it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for performance studies involving AI or diagnostic evaluations.

The provided text is a regulatory submission for a physical medical device, specifically a suture anchor. The "performance data" referred to in the document relates to mechanical properties and comparison to predicate devices, not to statistical performance metrics like sensitivity, specificity, or F1-score derived from a dataset with a defined ground truth.

Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not include the type of information you are asking for (e.g., test set, training set, expert adjudication, MRMC studies, ground truth types, etc.). This information is typically found in the context of AI/ML or diagnostic device submissions, which involve analyzing data to establish performance characteristics.

Here's what I can extract from the provided text regarding performance, along with why other sections cannot be completed:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary. The performance testing is mentioned in a general sense ("performance testing conducted") but details about the sample size, type of test specimens (e.g., cadaveric bone, synthetic bone), or provenance are not included.

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):
This is not applicable as the study described is not a diagnostic or AI-based study requiring expert ground truth establishment from medical images or clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for the type of device and study 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 is a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical testing of a suture anchor, "ground truth" would typically refer to measured physical properties validated against engineering standards or established methods for assessing mechanical integrity. The document states "performance testing," which implies laboratory-based mechanical tests, but doesn't detail the specific "ground truth" (e.g., ultimate pull-out strength, fatigue life).

8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided text is a 510(k) summary for a physical medical implant (suture anchor), focusing on its substantial equivalence to predicate devices based on intended use and technological characteristics, including performance testing of its insertion and fixation properties. It does not provide the detailed study design, sample sizes for datasets, expert involvement, or statistical performance metrics that would be found in a submission for an AI/ML-based diagnostic device.

Ask a specific question about this device

The MedShape Solutions, Inc., WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair

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

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

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures

This document, K091202, is a Special 510(k) summary for the MedShape Solutions WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures. It asserts substantial equivalence to a previously cleared device (K083792) and other predicate devices, rather than detailing a new study with specific acceptance criteria and performance data for the 180X model itself.

Therefore, many of the requested categories for a new clinical study are not directly applicable or available in this submission. This 510(k) is primarily focused on demonstrating that the minor changes to the WedgeLoc™ suture anchor (the "180X" designation) do not raise new questions of safety and effectiveness, and thus do not require new acceptance criteria or a dedicated study for the device's performance against such criteria.

Here's the breakdown of what can be extracted from the provided text, and what cannot:

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

No explicit acceptance criteria or reported device performance against such criteria are provided for the WedgeLoc™ 180X Suture Anchor in this document. The submission argues for substantial equivalence based on the predicate device's established performance and the minor nature of the changes.

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

Not applicable. This 510(k) does not describe a new clinical study with a 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. This 510(k) does not describe a new clinical study with a test set and ground truth establishment.

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

Not applicable. This 510(k) does not describe a new clinical study with a test set and 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 device is a medical implant (suture anchor), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant (suture anchor), not an algorithm.

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

Not applicable. This 510(k) does not describe a new study that required ground truth establishment. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This 510(k) does not describe a machine learning model or a training set.

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

Not applicable. This 510(k) does not describe a machine learning model or a training set.

Summary of the document's content relevant to acceptance criteria and study:

The core of this Special 510(k) is the assertion that the WedgeLoc™ 180X Suture Anchor is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K083792) and the Arthrex PushLock™ Suture Anchor (K051219).

• Acceptance Criteria: The implied "acceptance criteria" for this Special 510(k) are that the minor differences between the new device and its predicates do not raise new questions concerning safety and effectiveness. This is a regulatory acceptance criterion for the submission itself, not a performance criterion for the device in a clinical study.
• Study That Proves the Device Meets Acceptance Criteria: The "study" isn't a new clinical trial but rather a comparative analysis of the technological characteristics of the WedgeLoc™ 180X Suture Anchor against its predicate devices. The document states:
  • "The proposed WedgeLoc™ 180X Suture Anchor is is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K08379) and the Arthrex PushLock™ Suture Anchor (K051219) in which the basic features and intended uses are the same."
  • "In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ Suture Anchors are equivalent."
  • "Any differences between the WedgeLoc™ 180X Suture Anchor and the predicate WedgeLoc™ or Arthrex PushLock™ Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness."

In essence, the "proof" is the argument of substantial equivalence based on a comparison of features, intended use, and technological characteristics, rather than new device-specific performance data. The device's performance is accepted as equivalent to the already cleared predicate devices.

Ask a specific question about this device

The Smith & Nephew TWINFIX PK FP Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair. Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illoiotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

The TWINFIX PK FP Anchor is a suture anchor manufactured from PEEK polymer. The pound in anchor is not preloaded with suture, incorporates a two piece anchor body and faciliates arthroscopic repair of soft tissue to bone. The design allows the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.

The provided text is a 510(k) summary for a medical device (Smith & Nephew TWINFIX PK FP Suture Anchor) and a clearance letter from the FDA. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as requested.

The document states that "The performance testing conducted demonstrates substantial equivalence to the Arthrex® PushLock™ suture anchor, cleared in K051219. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy." However, it does not provide details about what that performance testing was, what acceptance criteria were used, or the results of those tests.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided text. The requested information regarding specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not present in this document.

Ask a specific question about this device

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.

Ask a specific question about this device