(67 days)
reNOVO Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone.
The reNOVO™ Suture Anchor will be provided sterile for single use applications.
The sizes and materials are designed to address the indications cited.
This 510(k) submission for the reNOVO™ Suture Anchor System does not describe specific acceptance criteria and a study demonstrating the device meets those criteria in the way a performance study for, for example, an AI/ML device would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria or reported device performance metrics (e.g., tensile strength thresholds, pull-out force requirements) is provided in the document. The claim is one of substantial equivalence, meaning the device is considered to perform similarly to already legally marketed devices.
2. Sample size used for the test set and the data provenance
No test set or associated sample size is mentioned in the document. The submission is based on a comparison to existing devices, not a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no test set in the conventional sense, and thus no ground truth to be established by experts.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process described.
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
Not applicable. This is a medical device (suture anchor), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device submission, the "ground truth" for demonstrating safety and effectiveness is established by showing that its intended use, materials, operational principles, and indications are equivalent to those of predicate devices that have already been cleared by the FDA.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study (Basis for Substantial Equivalence):
The "study" that proves the device meets the "acceptance criteria" (which, in this context, is substantial equivalence) is a comparison to predicate devices.
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Acceptance Criteria (Implicit for Substantial Equivalence): The reNOVO™ Suture Anchor System must be shown to be substantially equivalent in intended use, materials, operational principles, and indications for use to legally marketed predicate devices. This implicitly means that its performance characteristics (e.g., mechanical properties, biocompatibility) are expected to be similar or equal to those of the predicate devices.
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Reported Device Performance (Implicit): The submission claims that "Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to the currently marked devices and present no substantial differences in design, material, intended use and function to the products on the table above." This statement serves as the "reported device performance" in the context of a 510(k) for a device like this.
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Predicate Devices Used for Comparison:
In essence, for this 510(k), the "study" is the analytical comparison of the reNOVO™ Suture Anchor System's characteristics (design, materials, indications, operational principles) against those of multiple already-cleared predicate suture anchors, rather than a separate clinical or bench performance study with specific metrics. The FDA's clearance (K071520) indicates they found this comparison sufficient to establish substantial equivalence.
§ 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.