(132 days)
The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair. Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, 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. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
The proposed ShapeLoc™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The ShapeLoc™ Soft Tissue Fastener is designed to use the principles of interference fit to reattached soft tissue intended for attachment into a hole created in bone. The ShapeLoc™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue against the bone wall; fastening it into place.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ShapeLoc™ Soft Tissue Fastener:
The document provided is a 510(k) summary for a medical device called the "ShapeLoc™ Soft Tissue Fastener." This type of submission is for demonstrating substantial equivalence to a predicate device, not necessarily for proving the absolute safety and effectiveness of a novel device through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating equivalence in performance characteristics to a previously cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with specific numerical thresholds for success, as might be seen in a clinical trial protocol. Instead, the document frames the assessment around "substantial equivalence" to the predicate device, the Arthrex Interference Screw (K062466), across various functional performance tests. The performance goal is to be comparable to or better than the predicate device in relevant mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device in tissue fixation strength | "functional performance testing has been conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength (pull-to-failure), dynamic loosening testing for the deployed assembly." |
| Equivalence in dynamic loosening characteristics | "dynamic loosening testing for the deployed assembly" |
| Dimensional verification | "dimensional verification" |
| Material safety (biocompatibility) | "material safety testing (both bio... compatibility)" |
| Material safety (MRI compatibility) | "...and MRI compatibility)" |
| Substantial equivalence conclusion | "Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the functional performance testing. It mentions "Sawbone® and porcine bone analogues" as the materials for testing, implying an in-vitro or ex-vivo experimental setup. The data provenance is from this laboratory testing; there is no mention of human subject data, retrospective, or prospective studies in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is not applicable to the data presented in this 510(k) summary. The "ground truth" for the performance testing is based on objective measurements of mechanical properties (e.g., force required for pull-to-failure, displacement during dynamic loosening) from laboratory tests on bone analogues, not on expert interpretations of clinical data. Therefore, there were no experts establishing "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
This is not applicable to the data presented. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret medical images or clinical data to reach a consensus ground truth. The presented study involves objective mechanical testing, where the "truth" is derived from direct measurements and engineering analysis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The 510(k) summary describes laboratory-based mechanical performance testing for substantial equivalence, not a clinical diagnostic performance study. There is no AI component mentioned in the context of human reader improvement.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Study was Done
No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI algorithm. The performance evaluation is of the fastener's mechanical properties, not an algorithm's diagnostic or predictive capabilities.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this context is based on objective mechanical measurements obtained from testing the device in "Sawbone® and porcine bone analogues." This includes measurements like force (for pull-to-failure) and displacement (for dynamic loosening). This is an engineering ground truth, not a clinical ground truth like pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical implant, not an AI model that requires a training set. The term "training set" is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a physical implant 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.