(90 days)
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures
Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction
The EXTREMITY MEDICAL Suture Anchor
The provided text is a 510(k) summary for the EXTREMITY MEDICAL Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for meeting specific acceptance criteria derived from device performance.
Therefore, the requested information regarding acceptance criteria, device performance testing, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be found in the provided document.
This type of 510(k) submission generally relies on a comparison of design, materials, and intended use to existing legally marketed devices, rather than extensive clinical performance studies with specific statistical acceptance criteria. The "study" here is essentially the comparison to predicate devices, and the "acceptance criterion" is substantial equivalence.
Here's what can be extracted based on the nature of the document:
While the document doesn't present traditional "acceptance criteria" and a "study" to meet them in the context of device performance metrics (like sensitivity, specificity, accuracy for an AI device, or specific mechanical thresholds for a medical device), it does present the implicit acceptance criteria for its regulatory pathway: Substantial Equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for 510(k) Pathway) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Same indications for use
- Similar design
- Similar materials
- Similar principles of operation | The EXTREMITY MEDICAL Suture Anchor is substantially equivalent to its predicate devices (TwinFix Ti 2.8 Suture Anchor K972326, TwinFix PK FP Suture Anchor K073509) based on:
- Same indications for use
- Similar design
- Similar materials
- Similar principles of operation |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This 510(k) summary does not describe a performance study with a "test set" in the traditional sense of clinical or technical data. The "test set" here is conceptually the comparison of the new device's characteristics against the predicate devices.
- Data Provenance: Not applicable. The data is descriptive of the device itself and its comparison to existing devices, not empirical performance data from patients or laboratory tests for this specific device in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts for a test set is not described in this 510(k) summary, as it's not a performance study.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is 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 device is a physical suture anchor, not an AI or imaging device, and therefore an MRMC study with human readers assisting AI is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of a performance study. The "ground truth" for the 510(k) substantial equivalence claim is the established legal marketing status and characteristics of the predicate devices.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not a study involving machine learning or statistical modeling.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory submission for substantial equivalence of a physical medical device, not a report on a performance study with quantitative acceptance criteria and a test 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.