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The Smith & Nephew FOOTPRINT Ultra PK suture anchor family 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.

Hip: Distal row abductor tendon repair.

The FOOTPRINT Ultra PK is a suture anchor manufactured from 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 K113274 describes an indication expansion for the FOOTPRINT Ultra PK suture anchor. The main point of the submission is to justify the substantial equivalence of the device for "distal row abductor tendon repair" in the hip.

Here's an analysis of the provided information, specifically focusing on acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., a minimum pull-out strength in Newtons) nor does it provide detailed quantitative reported device performance data. Instead, it relies on a qualitative statement of "substantial equivalence" to predicate devices.

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

The document does not provide details on the sample size used for the performance testing. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

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

This information is not applicable and not provided. The study performed is a mechanical/physical performance test of a medical device, not a diagnostic or interpretation study requiring expert ground truth for a dataset.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As mentioned above, the study is a mechanical performance test.

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

No MRMC study was done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess the AI's impact on diagnostic accuracy. This submission is for a suture anchor, which is a physical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The FOOTPRINT Ultra PK suture anchor is a physical medical device, not an algorithm, so a "standalone" algorithmic performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this type of performance testing would be the actual physical properties (e.g., load to failure, displacement under load) measured in a laboratory setting. This is against established engineering and biomedical testing standards, not medical "ground truth" like pathology or outcomes data.

8. Sample Size for the Training Set

Not applicable. The FOOTPRINT Ultra PK suture anchor is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Summary of Device Performance Study Details:

The submission indicates that the basis for the indication expansion is performance testing focused on the mechanical properties of the suture anchor.

• Type of Study: Mechanical/physical performance testing (static and dynamic loading).
• Objective: To demonstrate "substantial equivalence" of the device's loading properties to predicate devices, and that any differences do not raise safety or efficacy concerns for the new indication (distal row abductor tendon repair).
• Key Assertion: "Clinical literature has shown equivalence between repair techniques for shoulder rotator cuff and hip abductor tendon repair." This statement implies that if the device performs equivalently for existing indications, and if the repair techniques are equivalent, then the device should also be suitable for the new indication.

Missing Information:

Crucially, the provided text lacks specific quantitative data for the performance testing. Details such as:

• The exact parameters measured (e.g., ultimate tensile strength, pull-out force, cyclic loading cycles to failure).
• The specific test protocols or standards followed.
• The actual numerical results from the tests for both the subject device and the predicate devices.
• The statistical methods used to compare the performance.

Without these quantitative details, a comprehensive description of the acceptance criteria and the proven performance is limited to the qualitative statements provided in the 510(k) summary.

Ask a specific question about this device

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