(120 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent static loading properties to predicates | "static loading properties that are substantially equivalent" |
| Substantially equivalent dynamic loading properties to predicates | "dynamic loading properties that are substantially equivalent" |
| No new safety or efficacy issues for distal row abductor tendon repair due to differences from predicates | "Testing also demonstrates that the differences in the FOOTPRINT Ultra PK suture anchor and the predicate does not raise any issues of safety and efficacy for distal row abductor tendon repair." |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.