(86 days)
The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Shoulder
• Biceps tenodesis
· Rotator cuff tear repair
The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer. The anchor consists of the following components: a proximal implant (REGENESORB or PEEK), a non-absorbable distal implant (PEEK or Titanium), and a nonabsorbable PEEK plug. The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & Nephew ULTRABRAID, ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.
The provided text describes the 510(k) premarket notification for the "HEALICOIL Knotless Suture Anchor" device. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain detailed information about acceptance criteria or specific study results that would typically be found in a comprehensive clinical or performance study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- Multi reader multi case (MRMC) comparative effectiveness study information
- Standalone (algorithm only) performance information
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and performance data from bench testing (insertion strength, pull-out strength, cyclic loading, sterilization, shelf-life, biocompatibility, bacterial endotoxin testing).
Here's what the document does provide regarding performance data:
Summary Performance Data (as reported in the document):
| Performance Aspect | Reported Outcome |
|---|---|
| Sterilization | Compared to predicate HEALICOIL REGENESORB Suture Anchor (K123393). (Implies comparability, not specific acceptance criteria or quantitative results are provided). |
| Shelf-life | Based on configurations of predicate HEALICOIL REGENESORB Suture Anchor (K123393) and reference devices MICRORAPTOR Knotless Suture Anchor (K181746) and BIORAPTOR 2.3 PK Suture Anchor (K071586). (Implies comparability, not specific acceptance criteria or quantitative results are provided). |
| Bacterial Endotoxin | Testing completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011. (Specific acceptance criteria not provided, but compliance to a standard is stated). |
| Biocompatibility | Evaluated against requirements per ISO 10993-1:2018. All acceptance criteria were met. (Specific acceptance criteria not provided, but compliance to a standard is stated). |
| Insertion Strength | HEALICOIL Knotless Suture Anchor had met performance specifications. (Specific specifications not provided). |
| Pull-out Strength | HEALICOIL Knotless Suture Anchor had met performance specifications. (Specific specifications not provided). |
| Cyclic Loading | HEALICOIL Knotless Suture Anchor met performance specifications based on the primary predicate FOOTPRINT PK Suture Anchor (K073509). (Specific specifications not provided, but reliance on predicate's performance is stated). |
Study Information (based on the provided text):
The document describes bench testing rather than a "study" in the traditional sense of a clinical trial or a study involving human readers or algorithms. The performance data summarized relates to the physical and biological characteristics of the device and its components, primarily to establish substantial equivalence with existing devices.
- Data Provenance: The studies are described as "performance data" and "bench testing." The specific location or retrospective/prospective nature of the data collection is not detailed, but it's implied to be laboratory-based testing conducted by the manufacturer or a contracted lab.
- Ground Truth / Experts / Adjudication / MRMC / Standalone / Training Set: These concepts are typically associated with studies evaluating diagnostic or AI-driven devices, neither of which applies to this submission for a surgical suture anchor. Therefore, the document does not contain information on these aspects. The "ground truth" for this type of device is usually established by objective engineering specifications, materials science standards (e.g., ISO for biocompatibility), and mechanical testing protocols.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence through comparison of the device's design, materials, and bench-level performance data against predicate devices, rather than a clinical study report with detailed acceptance criteria for diagnostic performance or AI effectiveness.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.