(76 days)
The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the lateral canthoplasty and collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture. when used to approximate soft tissue to bone during a period of rehabilitation.
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter.
The provided text describes a medical device, the Mitek Micro Anchor, and its non-clinical and clinical testing for FDA 510(k) clearance. However, it does not describe an AI/ML powered device or a study involving an algorithm. Therefore, many of the requested categories in your prompt are not applicable to the given input.
I will provide the information that is available from the text, indicating where information is not present or not relevant to this type of device submission.
Here's the analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated in a quantitative manner as "If X, then Y." Instead, the submission implies acceptance by demonstrating superior strength compared to the predicate device (suture) and by referencing historical data for the identical surgical procedure in clinical tests. The "performance" is primarily shown through pull tests.
| Metric (Implicit Acceptance Criteria and Reference) | Reported Device Performance (Average Failure Load in lbs, SD) |
|---|---|
| Predicate Device (USP Class I knot pull synthetic sterilized #4/0 suture) | 2.64 lbs |
| Mitek Micro Anchor Performance Comparison: | |
| Anchor pull strength (cadaver hand) - Should be greater than predicate | 9.67 lbs, SD 1.32 |
| Anchor pull strength (cadaver skull) - Should be greater than predicate | 7.97 lbs, SD 1.92 |
| Anchor pull strength (pig metacarpals) - Should be greater than predicate | 7.28 lbs, SD 0.72 |
| Suture with bone tunnels - Compared as another fixation method | 5.73 lbs, SD 0.46 |
Note: The intent is to show that the Mitek Micro Anchor's pull strength in various tissues is significantly greater than the standard #4/0 suture's pull strength (2.64 lbs), thus demonstrating its effectiveness. The specific threshold for "acceptance" is not numerically defined beyond this comparative superiority.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical (Pull Tests): Specific sample sizes for each pull test (cadaver hand, skull, pig metacarpals, suture w/ bone tunnels) are not explicitly stated. The "average failure load" suggests multiple tests were performed for each category, but the number of samples per average is missing.
- Clinical Tests: "clinical trials" are mentioned, conducted in accordance with IDE #G880026. The number of patients or procedures in these trials is not provided.
- Data Provenance: Not specified (country of origin). The clinical tests were likely prospective as they refer to "clinical trials." The non-clinical tests are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a surgical implant (anchor), not an AI/ML diagnostic tool. Ground truth in the context of expert review for image interpretation or similar AI applications is not relevant here. The "ground truth" for non-clinical testing is the measured mechanical failure load, and for clinical testing, it's patient outcomes as assessed by the surgeons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 is not an AI/ML device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical: Mechanical failure loads measured directly.
- Clinical: "Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure." This implies a form of clinical outcomes data (e.g., success of reattachment, absence of complications) compared against historical benchmarks.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.