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510(k) Data Aggregation
(263 days)
The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use 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, Anterior Shoulder Instability
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
The Responsive Arthroscopy (RA) Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polvether ether ketone (PEEK) per ASTM F2026 and Ti-6AI-4V ELI titanium alloy per ASTM F136, along with drivers, taps, and guide wires for screw insertion.
The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 20-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.
The RA Interference Screw System implants are provided sterile, and the RA Interference Screw System instruments are non-sterile and are to be sterilized by the end user. The RA PEEK Screws are sterilized with ethylene oxide (EO). The RA Titanium Interference Screws are sterilized with gamma radiation.
The provided text describes the 510(k) premarket notification for the "Responsive Arthroscopy Interference Screw System." This document is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It focuses on the device's design, materials, indications for use, and performance testing to support this claim.
However, the text does not contain the specific information requested about acceptance criteria and study details related to an AI/ML device. The document is about a mechanical surgical screw system, not an AI/ML-driven diagnostic or treatment device. Therefore, I cannot provide the requested details using the provided input.
The sections for acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not applicable to the submitted document.
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(105 days)
The BIOSURE HEALICOL PK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications: Knee (ACL repairs, PCL repairs, Extra-capsular repairs, Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquus advancement, Iliotibial band tenodesis), Shoulder (Acromioclavicular separation repairs, Biceps tenodesis), Foot and Ankle (Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Flexor hullucis longus (FHL), Tendon transfers), Elbow, Wrist, and Hand (Bicens tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers, Carpomedicarpal joint arthroplasty)
Smith & Nephew BIOSURE HEALICOIL PK interference screw is a non-absorbable, sterile, single-use, interference screw composed of Polyetheretherketone (PEEK). It has a fenestrated open design which allows for bone ingrowth. It is provided in size ranging from 6mm to 10 mm diameter. BIOSURE HEALICOIL interference screw minimizes the volume of material implanted into the body while providing equal fixation strength of a standard interference screw. The central channel of the screw can be packed with autologous bone.
The provided document describes the Smith & Nephew BIOSURE HEALICOIL PK Interference Screw, a non-absorbable, sterile, single-use interference screw made of PEEK. The document focuses on establishing substantial equivalence to legally marketed predicate devices rather than providing acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested points related to AI performance, ground truth establishment, expert review, and sample sizes for training/test sets are not applicable.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to predicate devices, meaning it does not define specific acceptance criteria in the traditional sense of a performance metric to be met by a new device against a predefined threshold. Instead, it aims to demonstrate that its performance is comparable to already cleared devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength (Pull-out and Insertion) | "Mechanical testing data for pull out and insertion testing demonstrates the BIOSURE HEALICOIL PK interference screw is substantially equivalent to the currently marketed predicate devices." |
| Bone Ingrowth (Qualitative) | "µCT demonstrated at twelve weeks that there was bone between the fenestrations and within the central cannulations. Histology and analysis demonstrated that new bone formed within the BIOSURE HEALICOIL PK interference screw and control in the fenestration between the threads into the central channel in all specimens." (Note: This was an animal study, and the document explicitly states: "Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having variety of bone quality based on specific disease states such as osteoporosis.") |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to mechanical testing and an animal study.
- Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out and insertion).
- Animal Study: The animal study used a sample size of n=11 for the BIOSURE HEALICOIL PK interference screw and n=11 for the control group. The provenance of this data (e.g., specific animal model, institution) is not detailed, but it is explicitly an animal study and not human data. It is a prospective study by nature of being conducted to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a physical medical implant, not an AI or diagnostic device that requires expert interpretation for establishing ground truth on a test set. The evaluation relies on mechanical and histological analysis.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" in the context of interpretation or diagnosis that would require an adjudication method like 2+1 or 3+1. The evaluation methods were mechanical testing and histological analysis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used:
- Mechanical Testing: The ground truth for mechanical performance (pull-out and insertion strength) would have been established by direct measurements using calibrated testing equipment, following established engineering standards.
- Animal Study (Bone Ingrowth): The ground truth for bone ingrowth was established through:
- Micro computed tomography (µCT): Provides detailed 3D imaging of bone structure.
- Histology: Microscopic examination of tissue samples to assess new bone formation.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning device that requires a training set. The device design and materials are based on established engineering principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set.
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