(27 days)
The GRAVITY PEEK-OPTIMA® Suture Anchor System is indicated for use:
· In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
• In the repair of elbow instability secondary to biceps tendon detachment, temis elbow, or ulnar or radial collateral tear/ separation;
• In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, or radial collateral ligament;
• In the repair of knee instability secondary to tear or separation of the medial collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
• In the repair of foot/ankle instability secondary to tear or separation of the Achilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:
o Achilles reattachment/reconstruction
- o Flexor Digitorum Longus Transfer
- o Flexor Hallucis Longus Transfer
- o Extensor Hallucis Longus Transfer
- o Brostrom Procedures
- o Peroneal Tendon Relocation
- o Capsule Repair
- o Deltoid reconstruction / reattachment
- o Plantar Plate Repair
- o Spring Ligament Repair
The GRAVITY " PEEK-OPTIMA® Suture Anchor System is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The GRAVITY™ PEEK-OPTIMA® Suture Anchor System comes preloaded with non-absorbable polyethylene sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized sutures.
This document describes a 510(k) premarket notification for the GRAVITY PEEK-OPTIMA® Suture Anchor System, a medical device used to attach soft tissue to bone. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your request regarding acceptance criteria and study proving device performance:
1. A table of acceptance criteria and the reported device performance:
The document states: "Bench testing was used to demonstrate that the pullout strength characteristics of the GRAVITY™ PEEK-OPTIMA® Suture Anchor System are substantially equivalent to the predicate systems."
Unfortunately, the specific acceptance criteria (e.g., minimum pullout strength in Newtons) and the actual reported device performance (e.g., measured pullout strength values) are not provided in this summary. The document only states that bench testing was performed and that the results demonstrated substantial equivalence.
Therefore, a table cannot be constructed with the detailed numerical information you requested from this document. The table would conceptually look like this if the data were present:
| Performance Characteristic | Acceptance Criteria (e.g., vs. Predicate or Numeric) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Pullout Strength | Substantially equivalent to predicate systems | Specific data not provided | Not stated |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "bench testing" but does not specify the sample size used for this testing.
- Data Provenance: The document does not specify the country of origin for the data. Given it's a submission to the US FDA, it's highly likely the testing was conducted in the US or in a facility adhering to US standards. The testing is described as "bench testing," meaning it's in-vitro, controlled laboratory testing, not involving human or animal subjects in a clinical setting.
- Retrospective or Prospective: "Bench testing" is inherently a prospective activity, as experiments are designed and conducted to generate new data for the submission.
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 this type of device and study. The "test set" in this context refers to physical devices undergoing mechanical tests (pullout strength). The "ground truth" for such tests is established by calibrated laboratory equipment and standardized testing protocols, not by expert opinion or interpretation in the way, for example, a medical imaging AI would establish ground truth from radiologists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable for the same reasons as above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert consensus (e.g., multiple radiologists reviewing images) to resolve discrepancies. Bench testing relies on objective, measurable physical properties.
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, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to AI-powered medical imaging or diagnostic devices where human readers (e.g., radiologists) interact with an AI system. The GRAVITY PEEK-OPTIMA® Suture Anchor System is a mechanical implant device, and its performance is evaluated through material properties and mechanical testing, not through human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This concept applies to AI/software devices. The device described is a physical medical implant. The "performance" studies done were mechanical bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench testing would be established by the calibrated measurement of physical properties like force (e.g., in Newtons) and displacement using laboratory equipment according to recognized testing standards. It is not based on expert consensus, pathology, or clinical outcomes data, as these are primarily in-vitro mechanical tests.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant.
§ 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.