(29 days)
The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
Ankle: Achilles tendon repair/reconstruction.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893).
This document is a 510(k) summary for a medical device called "Super QuickAnchor Plus." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving acceptance criteria in the same way a new, high-risk device might. Instead, it focuses on demonstrating that the new device is as safe and effective as an existing one.
Based on the provided text, here's an analysis against your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical trial or performance study for a novel device. Instead, the core "acceptance criteria" here is demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Functional Equivalence: Performs the same intended use. | The "Super QuickAnchor Plus" is intended for "fixation of USP size #2 through #5 suture to bone" for shoulder, ankle, and knee indications, which aligns with the general function of bone fixation anchors. The predicate device (Mitek SuperAnchor QuickAnchor, K980893 and K930893) performs the same function. |
| Technological Equivalence: Similar technological characteristics. | The "Super QuickAnchor Plus" is described as an "upgrade of the current Super QuickAnchor." The anchor itself is "identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893)" in terms of materials (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs). The "improvements" are in "enhanced ergonomics, and improved visualization" through single-handed operation and increased inserter shaft length, which are considered design refinements, not fundamental technology changes. |
| Safety and Effectiveness Equivalence: No new questions of safety or effectiveness. | The document states: "Biocompatibility studies have demonstrated the Super Anchor QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic." This confirms that the materials used (which are the same as the predicate's anchor) meet biocompatibility standards. The functional and technological similarities, coupled with biocompatibility, are used to argue that the device is as safe and effective as the predicate. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k). |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable in the context of this 510(k) submission. This document does not describe a clinical performance study using a "test set" of patients or cases. The biocompatibility studies would typically involve in-vitro or in-vivo testing on material samples, not a patient "test set". The document does not specify their sample sizes.
- Data provenance: Not applicable for a clinical test set. The biocompatibility studies' provenance is not detailed (e.g., country of origin, retrospective/prospective). These are typically laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not present. A clinical ground truth for a test set is not established in this type of submission.
4. Adjudication method for the test set
- This information is not present, as no clinical test set 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
- This information is not present. This device is a bone fixation anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not present. This device is a surgical implant and delivery system, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the core claim of "substantial equivalence," the "ground truth" is established by the existing, legally marketed predicate device (Mitek SuperAnchor QuickAnchor K980893 and K930893). The new device is compared against the characteristics and performance of this predicate.
- For biocompatibility, the "ground truth" would be established by standard biological safety testing methods to determine non-toxicity, non-irritation, and non-cytotoxicity, as per ISO 10993 or equivalent standards. The results of these tests (stated as having "demonstrated" the device is safe) are the ground truth for that specific safety aspect.
8. The sample size for the training set
- This information is not present. There is no "training set" in the context of this medical device submission, as it is a physical implant and not a machine learning model.
9. How the ground truth for the training set was established
- This information is not present, as there is no "training set" for this 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.