(147 days)
The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder (Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis), Elbow (Lateral Epicondylitis Repair), Wrist (Scapholunate Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
The proposed TransTend Anchors are suture anchors offered in three different materials, namely Biocryl Rapide, Titanium or Peek. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The TransTend Anchors are provided as size 3.4 mm in Biocryl Rapide, 3.4mm in Peek and 2.9 mm in Titanium. Each TransTend Anchor is provided sterile and is for single patient use only. The TranTend anchors will also be offered in a convenience kit and be packaged with a cannula assembly along with one or two TransTend Anchor(s).
The provided 510(k) summary for the TransTend Anchors does not include explicit acceptance criteria with numerical thresholds, nor a specific study demonstrating compliance to such criteria in the manner typically seen for diagnostic AI/ML devices.
Instead, this submission is for a medical device (surgical suture anchors) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicates and general safety and performance standards for such devices.
Here's an breakdown based on the information provided, framed as closely as possible to your request, but acknowledging the difference in device type:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Implied by Submission) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence | Materials (Biocryl Rapide, Titanium, Peek) are the same as predicates. |
| Design Equivalence | Design characteristics (e.g., preloaded on disposable inserter, intended for fixation of #2 suture) are similar to predicates. |
| Packaging Equivalence | Packaging is the same as predicates. |
| Functional Performance (Mechanical) | Pull-out testing and insertion torque testing were performed. Results deemed suitable for intended use. |
| Biocompatibility | Biocompatibility testing was performed. Results deemed suitable for intended use. |
| Sterilization | Sterilization testing was performed. Results deemed suitable for intended use. |
| Safety and Performance | "Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the mechanical, biocompatibility, or sterilization tests. It describes "Verification activities" and "Testing," but no detailed protocols or sample numbers are provided for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and testing described. The "ground truth" for a bone anchor is its physical and biological performance, which is assessed through engineering and biological tests, not expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies where expert consensus is needed. For mechanical and biological testing of a physical device, the "truth" is determined by the objective measurements of the tests themselves, against established standards or predicate performance.
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
This question is not applicable. MRMC studies are specific to diagnostic AI/ML devices where human readers interpret cases, and the AI's impact on their performance is evaluated. This submission is for a surgical implant (bone anchor), not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The TransTend Anchors are a physical surgical device, not an algorithm, so there is no "standalone" algorithm performance to assess.
7. The type of ground truth used
For this device, the "ground truth" is established through:
- Engineering Test Results: Objective measurements from mechanical tests (pull-out strength, insertion torque) compared against functional requirements and predicate device performance.
- Biological Test Results: Objective measurements from biocompatibility tests, following established standards (e.g., ISO 10993).
- Sterilization Validation: Objective verification of sterility assurance levels.
8. The sample size for the training set
This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning algorithms. The design and manufacturing process are informed by general engineering principles, material science, and the performance characteristics of predicate devices, rather than a data-driven training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #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.