(149 days)
To hold a Semi Tendonosus ST (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstrution surgery.
Femoral fixation of autograft or allograft ACL soft tissue grafts
The Cross Pin is 1.654 " long by 0.132" dia. with a conical tip by 0.180" long. The Cross Pin is molded from Purac PLA.
The provided text describes a submission for a medical device (Mitek 3.3mm ST Cross Pin) seeking 510(k) clearance. The document focuses on comparing the new device to a predicate device (Acufex EndoButton) to establish substantial equivalence based on non-clinical tests.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fixation Strength (Bench Tests) | Statistical equivalence (in both strength and stiffness) to the Acufex EndoButton. |
| Bending (Bench Tests) | Statistical equivalence to the Acufex EndoButton. |
| Shear (Bench Tests) | Statistical equivalence to the Acufex EndoButton. |
| Effect of Cross Pin Orientation on Ultimate Strength of Hamstring Grafts | In-vitro evaluation tests were conducted to show this effect. (No specific performance metric or "acceptance" is stated for this; it's a descriptive test.) |
2. Sample size used for the test set and the data provenance
The text mentions "Bench fixation strength tests, bending and shear" and "In-Vitro evaluation tests." However, it does not specify the sample size used for these tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective, as these were bench and in-vitro tests, not human trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The "tests" performed were non-clinical bench and in-vitro evaluations of mechanical properties, not diagnostic or clinical assessments requiring expert ground truth establishment in the traditional sense for medical imaging or clinical outcome studies.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews where there's a need to resolve discrepancies in observations or diagnoses. Since these were bench tests, an adjudication method for a test set is not relevant.
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
No MRMC study was done. The document explicitly states: "No clinical tests were done." This device is a mechanical implant, and the study was focused on its mechanical properties compared to a predicate device, not on diagnostic accuracy or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical medical implant (a cross pin), not an algorithm or AI system. Therefore, standalone performance in the context of an algorithm is irrelevant.
7. The type of ground truth used
For the bench fixation strength, bending, and shear tests, the "ground truth" was established by direct measurement of physical properties (strength, stiffness) of the devices under controlled experimental conditions. For the in-vitro evaluation tests, the "ground truth" was the directly measured ultimate strength of the hamstring grafts under various cross pin orientations. This is based on objective, quantifiable physical properties rather than expert consensus or pathology in a biological sense.
8. The sample size for the training set
This information is not applicable and not provided. The assessment was a direct comparison of physical properties of two medical devices. There was no "training set" in the context of machine learning or predictive modeling.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8. There was no training set.
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Image /page/0/Picture/0 description: The image shows the logo for Mitek Products. The word "mitek" is in bold, black letters, with a registered trademark symbol next to the "k". Below the word "mitek" is the word "PRODUCTS" in smaller, black letters. The logo is simple and easy to read.
ETHICON,INC.
a Johnson Johnson company
PHONE (781) 251-2700 • TOLL-FREE (800) 356-4835 • FAX (781) 461-9166
APR 1 6 1998
510k SUMMARY FOR K974341
Page 1 of 2
SUBMITTER
NAME ADDRESS Tel No. CONTACT DATE
Mitek Products 60 Glacier Drive, Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs October 20, 1997
NAME OF DEVICE
CLASSIFICATION NAME COMMON NAME PROPRIETARY NAME
Staple, fixation, bone and soft tissue A device for holding soft tissue in apposition Mitek 3.3mm ST Cross Pin
PREDICATE DEVICE
Acufex EndoButton (K) 933948
DESCRIPTIION OF DEVICE
FUNCTION
Hold a Semi Tendonosus soft tissue graft in position during healing in the femoral bone tunnel.
DEVICE DESIGN
The Cross Pin is 1.654 " long by 0.132" dia. with a conical tip by 0.180" long.
MATERIALS USED
The Cross Pin is molded from Purac PLA
INTENDED USE
To hold a Semi Tendonosus ST (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstrution surgery.
COMPARISON TO PREDICATE DEVICE
The PLA 3.3mm ST Cross Pin compares to the Acufex EndoButton in that the indication for use is the same and the function of the device(s) are similar. They hold a soft tissue graft in position in the femoral tunnel during the healing process after ACL reconstructive surgery. The Cross Pin holds the device by having passed through the graft within the bone tunnel, facilitated by use of the Mitek ACL guide system, and into the opposite bone tunnel wall of the femur. The EndoButton holds the soft tissue graft in place with suture/tape which is then anchored over the EndoButton which is placed onto the anterior lateral femoral cortex.
DESCRIPTION OF NON CLINICAL TESTS
Bench fixation strength tests, bending and shear, were done comparing the Acufex EndoButton and the Mitek 3.3mm ST Cross Pins. These tests showed statistical equivalence between the two devices, in both strength and in stiffness. Also, In-Vitro evaluation tests were conducted to show the effect of cross pin orientation on the ultimate strength of the hamstring grafts in ACL reconstruction.
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DESCRIPTION OF CLINICAL TESTS No clinical tests were done.
CONCLUSIONS FROM TESTS
The bench test data and the overall graft delivery and bone tunnel preparation work show that the devices are applied in a similar manner and perform equally.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1998
Mr. Edward F. Kent · Vice President, Regulatory Affairs Mitek® Products 60 Glacier Drive Westwood, Massachusetts 02090
Re: K974341 Trade Name: 3.3mm ST Cross Pin Regulatory Class: II Product Codes: HTY and MAI Dated: February 25, 1998 Received: February 27, 1998
Dear Mr. Kent:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Edward F. Kent
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
- Stephen Plurchie
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of_f -Page
510(k) Number (if known): _ K974341
Device Name: Mitek 3.3mm (ST) Cross Pin
Indications For Use:
- 1
Femoral fixation of autograft or allograft ACL soft tissue grafts
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stiphan Edwards
(Division Sigh-Off) Division of General Restorative Devices K974341 510(k) Number _
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.