(73 days)
The Smith & Nephew HEALICOIL PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs, Slap lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis. Knee: Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament. Patellar realignment and tendon repairs: Vastus medialis obliquous advancement, Iliotibial band tenodesis. Foot & Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstruction, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions. Elbow: Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment. Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair.
The HEALICOIL PK Suture Anchor is manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5mm and 5.5mm sizes. The screw-in anchor is preassembled onto a stainless steel inserter and pre-loaded with up to three strands of suture.
The Smith & Nephew HEALICOIL PK Suture Anchor is intended for the reattachment of soft tissue to bone. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that the provided documentation is a 510(k) summary, which often relies on equivalence to predicate devices and provides summary data, not full study protocols or raw data.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Bone Growth within Anchor | Demonstrates new bone formation within the HEALICOIL PK Suture Anchor in the fenestrations between threads and into the central channel. | Micro-CT and histology analysis demonstrated that new bone formed within the HEALICOIL PK suture anchor in the fenestrations between the threads and into the central channel in all specimens (12 weeks post implantation). This supports the claim that "The open architecture of the HEALICOIL PK Suture Anchor allows for new bone to fill the fenestrations between threads and into the central channel." |
| Bone Volume Percentage | The HEALICOIL PK Suture Anchor should contain a measurable percentage of new bone volume comparable to intact bone by 12 weeks post-implantation. | Micro-CT analysis of new bone formed within the HEALICOIL PK suture anchor demonstrated that 21.9% of the implant volume was new bone by 12 weeks post-implantation (n=12). This was measured against a control of intact bone from the same anatomical site, which had an average bone volume of 34.5% (n=12). The stated acceptance criterion is that the anchor contained "63% of the bone volume of control bone by 12 weeks post-implantation in sheep" (21.9% / 34.5% ≈ 63.5%). The data supports this claim. |
| Substantial Equivalence | Device is substantially equivalent in intended use and fundamental scientific technology to the predicate device: Smith & Nephew Next Generation Fully Threaded PK Suture Anchor (K110545). | The K113294 submission states: "The Smith & Nephew HEALICOIL PK Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Smith & Nephew Next Generation Fully Threaded PK Suture Anchor (K110545)." And further: "The Smith & Nephew HEALICOIL PK Suture Anchor is substantially equivalent in design, materials, technological characteristics, intended use, and indications for use to its currently marketed predicate device..." This general statement of equivalence by the manufacturer and accepted by the FDA implies that performance in general, beyond the specific animal study, is considered equivalent. |
| Mechanical Performance | No change in performance characteristics from the predicate device due to design modifications. | "There have been no design modifications that required additional mechanical testing. Performance characteristics of the anchors have not changed from those described in K110545." This indicates that previous mechanical testing data for the predicate device is considered applicable and sufficient. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 12 ovine (sheep) cancellous bones were implanted with HEALICOIL PK Suture Anchors. Additionally, 12 control intact bone samples from the same anatomical site were used for comparison of bone volume.
- Data Provenance: The study was an animal study conducted using ovine cancellous bone. The specific country of origin is not specified but is a prospective animal study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used for establishing ground truth for the animal study. The analysis involved micro-CT and histology, which would typically be interpreted by veterinary pathologists or imaging specialists, but no details are provided about their expertise or roles.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for interpreting the micro-CT or histology results. It simply states that analysis "demonstrated" specific findings.
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
No MRMC comparative effectiveness study was conducted or mentioned. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical suture anchor, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the animal study, the ground truth was established through:
- Micro Computed Tomography (micro-CT) analysis: This provides quantitative data on bone volume and structure.
- Histology analysis: This provides microscopic examination of tissue, confirming the presence and nature of new bone formation.
8. The Sample Size for the Training Set
The document does not describe a "training set" as this is not an AI/ML device. The study described is a single animal study to evaluate specific biological responses to the implant.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.