(80 days)
Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsulo repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications – Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications -- Medial collateral ligament repair, lateral collateral ligament repair, Ande indications - Medial Sollatora. neems. If intibial band tenodesis, and patellar ligament/tendon repair.
The Metal Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured out of theuile for ucasioning con is available in two sizes, 3.0 mm. The screw anchor consists of a screw portion and a head portion. The 3.0 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.0 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Metal Scrow Anchor will be packaged sterile and will be preloaded on a driver with suture.
The presented document is a 510(k) premarket notification for a medical device called the "Metal Screw Anchor." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance.
Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and how ground truth was established for training sets) are not applicable or not explicitly detailed in this type of regulatory document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Typically for Clinical Performance) | Reported Device Performance (from submission) |
|---|---|
| Not explicitly stated/defined in the K012503 submission | Substantially equivalent to predicate devices |
- Explanation: The 510(k) process for this device relies on demonstrating substantial equivalence, primarily through non-clinical testing comparing it to legally marketed predicate devices. The document explicitly states: "Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, there are no "acceptance criteria" for clinical performance in the sense of a clinical trial with pre-defined thresholds. The unstated "acceptance criterion" is that the device performs at least as well as the predicate in relevant mechanical tests and has similar technological characteristics.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No clinical "test set" was used as clinical testing was not performed for substantial equivalence. For non-clinical (mechanical) testing, sample sizes are not provided in this document.
- Data Provenance: Not applicable. Clinical data was not used. For non-clinical testing, the testing was performed by the applicant (Arthrotek, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No clinical "test set" requiring expert ground truth was used.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No clinical "test set" requiring adjudication was used.
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
- MRMC Comparative Effectiveness Study: No. This device is a physical medical implant (Metal Screw Anchor), not an AI-powered diagnostic or decision-support tool. It does not involve human readers interpreting output from the device, so MRMC studies are not relevant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical medical implant, not an algorithm. Standalone performance studies are not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for clinical performance. For the mechanical non-clinical testing, the "ground truth" would be the measured physical properties (e.g., pull-out strength, stiffness) of the device and the predicate devices, established through standard engineering/mechanical testing protocols.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. Clinical data was not used. No AI/machine learning model was trained for this device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. No training set was used.
Summary of Device Rationale from Document:
The Metal Screw Anchor establishes substantial equivalence based on:
- Similar Technological Characteristics: "The Metal Screw Anchor's technological characteristics (materials, design, sizes, and indications) are similar to the predicate device."
- Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
- No Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."
The predicate devices are the Harpoon Suture Anchor (Biomet, Inc., K943806/K973775). The regulatory pathway for this device (510(k)) focuses on demonstrating that the new device is as safe and effective as a legally marketed predecessor, primarily through comparison of design, materials, and mechanical performance, rather than new clinical trials with specified acceptance criteria on clinical outcomes.
§ 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.