(14 days)
The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone 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 Liqament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
The ExoShape™-XL Interference Fixation Device is a line extension offering additional sizes within the current cleared product line and is substantially equivalent to the ShapeLoc (original product name) Soft Tissue Fastener, cleared under K101808. The technological characteristics of the ExoShape™-XL and the ShapeLoc Interference Fixation Devices are equivalent.
The provided text describes a Special 510(k) submission for the MedShape Solutions ExoShape™-XL Interference Fixation Device, which is a line extension of an already cleared device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device.
Therefore, the requested information about acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document. This document is a regulatory submission for a device modification (line extension) based on substantial equivalence, not a detailed clinical or performance study report with explicit acceptance criteria and corresponding results as typically seen for entirely new devices or software.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list numerical acceptance criteria. Instead, it states that "Functional performance testing was conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength and other dimensional verification. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the listed devices."
This implies that the acceptance criterion was likely substantial equivalence in performance (particularly fixation strength and dimensional characteristics) compared to the predicate devices. The "reported device performance" is that it met this substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in: | Met. Analysis of results supports the conclusion that the proposed device is substantially equivalent to the listed devices. |
| - Monotonic soft tissue fixation strength | Demonstrated to be substantially equivalent to predicate devices. |
| - Dimensional characteristics | Demonstrated to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "functional performance testing" was conducted but does not provide details on the number of samples (devices, Sawbones, or porcine bones) used.
- Data Provenance: The testing was conducted in "Sawbone® and porcine bone analogues." This indicates that the data is from pre-clinical, in-vitro (Sawbone) and ex-vivo (porcine bone) testing. The document does not mention human data (prospective or retrospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of submission. This device is a physical medical implant, and the testing described is mechanical performance (fixation strength, dimensions), not diagnostic or interpretative. Thus, there is no "ground truth" established by human experts in the context of interpretation, nor are there experts involved in establishing a "ground truth" for mechanical testing in the way that there would be for, say, an AI-powered image analysis system.
4. Adjudication method for the test set:
- Not applicable. As described above, this is mechanical performance testing, not expert interpretation.
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. This is a physical medical device (implant) and not an AI-powered system designed to assist human readers or perform diagnostic tasks. Therefore, no MRMC study would be relevant or conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (implant), not an algorithm or AI system. Its performance is inherent in its mechanical properties.
7. The type of ground truth used:
- For the mechanical functional performance testing (e.g., monotonic soft tissue fixation strength, dimensional verification), the "ground truth" would be established by engineering measurements and biomechanical test standards/protocols. The performance of the predicate devices would serve as a benchmark against which the new device's performance is compared to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8).
§ 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.