(129 days)
Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior 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 or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair
The NanovaTM Suture Anchor is comprised of two types: Screw-In and Push-In. Nanova™ Screw-In Suture Anchor is a cannulated, threaded, tapered anchor with integral eyelet for suturing soft tissue to bone. Nanova™ Push-In Suture Anchor is a cannulated anchor with integral evelet for suture soft tissue to bone. In addition the Push-In anchor can use a knotless technique by capturing suture. Suture anchors are preloaded with suture on a handled inserter with a hex driver. The device is made from a copolymer of absorbable 70-30 Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanoval Screw-In Suture Anchors are single use, prescription, long term implant, no drug.
The provided document is a 510(k) premarket notification for two medical devices: the Nanova Screw-in Suture Anchor and the Nanova Push-in Suture Anchor. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or not provided in this type of submission. The information below reflects what can be extracted from the document within the context of a 510(k) submission.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are generally based on demonstrating "similar performance" to the predicate devices through non-clinical testing. The document states that the mechanical and performance testing resulted in "similar mechanical and performance to the predicate." No specific numerical acceptance criteria or detailed device performance metrics (e.g., in a table with target values) are provided beyond this general statement.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass ISO 10993 standards | All testing passed (based on risk assessment) |
| Mechanical & Performance | Similar to predicated devices | All testing passed, similar strength to predicates |
| NANOVA™ SCREW-IN SUTURE ANCHOR | ||
| Axial Pullout Strength | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| Axial Fatigue Strength | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| Max Torque | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| Insertion Torque | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| Immersion Pullout Strength | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| NANOVA™ PUSH-IN SUTURE ANCHOR | ||
| Axial Pullout Strength | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| Axial Fatigue Strength | (Implied: Similar to predicate) | Tested, results were similar to predicate |
| Immersion Pullout Strength | (Implied: Similar to predicate) | Tested, results were similar to predicate |
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: This information is not provided in the document. The document mentions "non-clinical performance testing" which includes mechanical and performance testing, but the specific number of units tested is not disclosed.
- Data Provenance: The document does not specify the country of origin of the data or whether the testing was retrospective or prospective. Given it's non-clinical benchtop testing, these distinctions are less relevant than for clinical studies.
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)
This information is not applicable for this 510(k) submission. Ground truth establishment by experts (e.g., radiologists) is typically associated with clinical studies, especially those involving diagnostic devices or image interpretation. This submission focuses on the mechanical and biocompatibility properties of a physical implant (suture anchor), where "ground truth" would be determined by objective measurements and standardized testing protocols, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for this 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when multiple readers provide conflicting interpretations (e.g., in radiology studies). The non-clinical testing described involves objective mechanical measurements where adjudication by multiple experts is not relevant.
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 information is not applicable for this 510(k) submission. MRMC studies, especially those focusing on AI assistance, are relevant for diagnostic devices or software that assist human readers in interpreting medical data. The Nanova Suture Anchor is a physical surgical implant, not a diagnostic or AI-enabled device, so an MRMC study would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable for this 510(k) submission. "Standalone performance" refers to the performance of an algorithm or software operating independently without human intervention, which is relevant for AI-powered diagnostic tools. As mentioned, the Nanova Suture Anchor is a physical surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would be derived from objective measurements obtained through standardized laboratory testing methods and equipment (e.g., force gauges for pullout strength, torque wrenches for insertion torque, etc.). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests, as they are not clinical studies. The biocompatibility testing followed ISO 10993 standards, where "ground truth" is defined by the results meeting specific criteria or thresholds outlined in those standards.
8. The sample size for the training set
This information is not applicable for this 510(k) submission. "Training set" refers to data used to train machine learning algorithms. The Nanova Suture Anchor is a physical medical device, not an AI or software device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for this 510(k) submission, as there is no training set for a physical hardware device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.