(203 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 expand the indications to include the browlift procedure. 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 Threaded Anchor is a threaded design, 2.0 mm in diameter and 3.6 mm in length. It is manufactured from Titanium 6Al 4V. It is similar in design to the 3.0mm, 4.0mm and the 5.2mm Mitek Threaded Anchor. These designs were cleared to market in K945203.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Anchor pull strength greater than USP #2/0 suture (6.34 lbs) | Average failure load: 32.7 lbs (SD 1.9, N=30) |
| Anchor pull strength greater than tendinous tissue failure (15.75 lbs) | Average failure load: 32.7 lbs (SD 1.9, N=30) |
| Anchor pull strength greater than capsular tissue failure (21.80 lbs) | Average failure load: 32.7 lbs (SD 1.9, N=30) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: N=30 (for the Mitek Threaded Anchor pull tests).
- Data Provenance: Cadaveric locations (tissue type not specified beyond "cadaveric locations," but likely human). The study itself is an in vitro non-clinical test, not a clinical study on live subjects.
3. Number of Experts and their Qualifications for Ground Truth
This submission does not describe a process involving experts to establish ground truth for the in vitro pull tests. The "ground truth" for the acceptance criteria (suture strength, tissue failure strength) comes from a referenced publication, "Soft Tissue Fixation to Bone, Daniel B. Robertson, M.D. et al. The American Journal of Sports Medicine, Vol. 14, No. 5, 1986." The qualifications of the authors of this reference are not provided in the 510(k) summary.
4. Adjudication Method for Test Set
Not applicable. The non-clinical test involves physical pull tests, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission mainly presents results from non-clinical mechanical testing and a comparison to a predicate device.
6. Standalone Performance Study
Yes, a standalone study (non-clinical test) was performed to assess the device's mechanical strength independent of human interaction during the test. The "Mitek Threaded Anchor pull tests" represent this standalone performance.
7. Type of Ground Truth Used
For the non-clinical pull tests, the "ground truth" for comparison was established from:
- Standardized values for suture strength (USP #2/0 suture).
- Published data on the pull-out strength of various soft tissues (tendinous tissue, capsular tissue) as referenced from a scientific journal.
8. Sample Size for the Training Set
Not applicable. This submission describes a non-clinical test and a 510(k) for a device with a predicate. There is no mention of a "training set" in the context of an algorithm or machine learning. Clinical tests were performed as part of IDE #G880026, but the sample size for those clinical trials is not provided in this summary.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set for an algorithm is mentioned. For the IDE clinical tests, the safety and effectiveness were based on "results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure," suggesting a comparison against established clinical outcomes for the procedure. However, the details of how ground truth was established for those clinical trials (e.g., specific outcome measures, gold standards) are not provided in this summary.
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K961094
Oct. 3, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK THREADED 2.0mm ANCHOR
SUBMITTER:
NAME: Mitek Surgical Products, Inc. ADDRESS: 60 Glacier Drive, Westwood, MA 02090 TEL#: 617-461-9700 CONTACT: Edward F. Kent, Vice President, Regulatory Affairs DATE: March 12 . 1996
NAME OF DEVICE
CLASSIFICATION NAME: Staple, Fixation, Bone COMMON NAME: Appliance for reconstruction of bone to soft tissue PROPRIETARY NAME: MITEK THREADED ANCHOR
PREDICATE DEVICE: MITEK THREADED ANCHOR
DESCRIPTION OF DEVICE
FUNCTION
Fixation of USP #2/0 suture below bone surface.
DEVICE DESIGN
The Mitek Threaded Anchor is a threaded design, 2.0 mm in diameter and 3.6 mm in length. It is manufactured from Titanium 6Al 4V. It is similar in design to the 3.0mm, 4.0mm and the 5.2mm Mitek Threaded Anchor. These designs were cleared to market in K945203.
MATERIALS USED
The Mitek Threaded Anchor delivery system consists of a Mitek Threaded Anchor Tab, a drill bit ,and an Inserter.
INTENDED USE
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 expand the indications to include the browlift procedure. 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.
COMPARISON TO PREDICATE DEVICE
It has greater strength than USP #2/0 suture, and is the same design as the Mitek 3.0mm, 4.0mm and 5.2mm Mitek Threaded Anchors.
DESCRIPTION OF NON CLINICAL TESTS
The Mitek Threaded Anchor pull tests from cadaveric locations produced an average failure load of 32.7 Ibs, SD 1.9, N=30.
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USP knot pull synthetic sterilized suture, double strand, is 6.34 Ibs.
Suture tissue failure tendinous tissue is 15.75 lbs, and capsular tissue is 21.80 Ibs. Reference: Soft Tissue Fixation to Bone, Daniel B. Robertson, M.D. et al. The American Journal of Sports Medicine, Vol. 14, No. 5, 1986.
DESCRIPTION OF CLINICAL TESTS
The clinical tests were done in accordance with IDE #G880026. Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure.
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§ 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.