(92 days)
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
The Rimclose Bone Anchor consists of one (1) bone anchor assembly, pre-loaded on a disposable delivery tool. The Bone Anchor is packaged with a disposable Bone Awl to facilitate placement of the device. The device is provided in one size only.
The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustable polyethylene terephthalate (PET) 2-0 braided suture loop, via an intermittent length of size 0 ultra high molecular weight polyethylene (UHMWPE) Force Fiber suture.
The device's titanium component conforms to ASTM F-136. The device's polyethylene terephthalate (PET) and ultra high molecular weight polyethylene (UHMWPE) suture components conform to USP requirements. The constructs are provided sterile and preloaded on disposable delivery instruments.
The provided text is a 510(k) summary for the Rimclose Bone Anchor. It describes the device, its intended use, and states that substantial equivalence to a predicate device was established through biocompatibility and bench testing. However, it does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML devices or diagnostic tools.
Therefore, many of the requested sections will be answered as "Not applicable" or "Information not provided in the document."
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional/Safety Bench Testing (details not specified) | "demonstrated equivalent fixation strength which greatly exceeded the tensile strength of the suture." |
| Material Conformance (implied) | Titanium component conforms to ASTM F-136. PET and UHMWPE suture components conform to USP requirements. |
| Biocompatibility (details not specified) | Testing completed and supports safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Information not provided in the document. The document refers to "bench testing," which typically involves mechanical tests rather than human patient data.
- Data Provenance: Information not provided. Since it's bench testing, country of origin or retrospective/prospective is not applicable in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information not provided. For a physical device undergoing bench testing, "ground truth" and "experts" in the context of clinical interpretation are not applicable. The performance is typically measured against engineering specifications or known material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or expert consensus. For bench testing of a bone anchor, performance metrics are typically quantitative and objective.
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
- MRMC Study: No, this is not an AI/ML device or an imaging/diagnostic tool, so MRMC studies are not applicable.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone anchor), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's testing would likely be based on:
- Engineering specifications/standards: For material properties, dimensions, and mechanical strength (e.g., tensile strength, fixation strength).
- Predicate device performance: For comparison of equivalent fixation strength.
- USP requirements and ASTM standards: For material conformance.
8. The sample size for the training set
- Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant in the context of its testing for 510(k) clearance, which relies on bench testing and biocompatibility.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.