(38 days)
Retrograde suture through soft tissue
The suture retrograder is used to retrograde (pass) suture through soft tissue.
The provided text contains information about a 510(k) premarket notification for the MITEK Suture Retrograder, submitted in 1997. It describes the device, its intended use, and a comparison to predicate devices, but does not include any information about acceptance criteria, clinical studies, or performance metrics from such studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only states: "Bench tests were done to demonstrate performance equivalence to predicate devices on the market." This is a very general statement and does not provide the specific details you've requested about acceptance criteria or study methodologies.
Without more detailed information from the submission regarding the bench tests, their specific protocols, and the criteria used to demonstrate equivalence, it is impossible to answer your questions.
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January 10, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK SUTURE RETROGRADER
MAR 1 0 1997
SUBMITTER
| NAMEADDRESS | Mitek Products60 Glacier Drive, Westwood, MA 02090 |
|---|---|
| TEL # | 617-461-9700 |
| CONTACT | Edward F. Kent Vice PresidentRegulatory Affairs |
DATE
NAME OF DEVICE
| CLASSIFICATION NAME | SUTURE PASSER, 87HWQ |
|---|---|
| COMMON NAME | Instrument to retrograde suture throughtissue |
| PROPRIETARY NAME | MITEK Suture Retrograder |
PREDICATE DEVICE
Acufex suture retrograder, and Innovasive suture passer
DESCRIPTION OF DEVICE FUNCTION The suture retrograder is used to retrograde (pass) suture through soft tissue.
MATERIALS USED
The handle is molded from gamma stable Lexan with the remaining materials being made from stainless steel.
INTENDED USE
Retrograde suture through soft tissue
COMPARISON TO PREDICATE DEVICE(S)
Same function, hand held suture retrograde instrument to pass or retrograde suture through tissue in either open or arthroscopic procedures.
DESCRIPTION OF NON CLINICAL TESTS
Bench tests were done to demonstrate performance equivalence to predicate devices on the market.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.