(99 days)
The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures:
· Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.
· Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The Aevumed PHANTOM ™ Anchor with HS Fiber ™ suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM ™ Anchor with HS Fiber ™ are pre-loaded with or without needles. The Aevumed PHANTOM ™ Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only.
The provided text is a 510(k) Premarket Notification for a medical device (AEVUMED PHANTOM Suture Anchors). This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the provided text DOES NOT contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML-based medical devices. The document is for a traditional mechanical medical device (suture anchors) and the "NON-CLINICAL TESTS" section only mentions mechanical testing (Torsional Strength, Driving Torque, Pullout Strength) as the basis for substantial equivalence.
Therefore, I cannot extract the information required by your request, as the request pertains to the evaluation of an AI/ML device, and the provided document describes a non-AI/ML device.
Here's what I can tell you from the document regarding the "study" that proves the device meets the acceptance criteria, even though it's not an AI/ML study:
- Study Type: Non-clinical mechanical testing.
- Tests Conducted: Torsional Strength, Driving Torque, and Pullout Strength.
- Purpose: To demonstrate substantial equivalence to the predicate device (Arthrex Corkscrew FT) by showing comparable mechanical performance.
- Ground Truth: The mechanical properties of the predicate device serve as the de facto "ground truth" for comparison.
- Acceptance Criteria: While specific numerical acceptance criteria are not explicitly listed in this summary, the implication is that the Aevumed PHANTOM™ Suture Anchors must perform comparably to the predicate device in these mechanical tests to establish substantial equivalence.
To directly answer your numbered points based on the provided text, I must state that this information is not available for an AI/ML device study:
- A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML study. The document mentions mechanical tests (Torsional Strength, Driving Torque, Pullout Strength), but doesn't provide a table of acceptance criteria or specific numerical performance results for these non-clinical tests. It only states they were tested.
- Sample sized used for the test set and the data provenance: Not applicable for an AI/ML study. For the mechanical tests, the sample sizes and provenance of the test articles are not specified in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML study. Ground truth for mechanical testing is based on physical measurements, not expert consensus.
- Adjudication method for the test set: Not applicable for an AI/ML study.
- 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 mechanical device, not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
- The type of ground truth used: For this mechanical device, the "ground truth" is likely defined by the established mechanical standards and performance of the predicate device.
- The sample size for the training set: Not applicable. There is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.
§ 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.