(179 days)
The Implex Screw and Washer System is indicated for use in the attachment of ligaments, tendons and other soft tissue to bone.
The Implex Screw and Washer System consists of the Implex Continuum Bone Screw configured with a Hedrocel®/CP titanium Washer. The Implex Continuum Bone Screw has a 5 mm diameter and is offered in lengths from 15 to 65 mm, in 5 mm increments. The Washer is offered in two versions. Washer-A and Washer-A has a flat tissue-contacting Washer-B. surface and Washer-B has a flat tissue-contacting surface with recessed grooves. Both versions are round, and offered in three outer diameters, 14 mm, 17 mm, and 20 mm.
The provided text is a 510(k) summary for the Implex Screw and Washer System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to material and structural properties, rather than clinical studies involving human readers or AI.
Therefore, many of the requested elements for describing an acceptance criteria study, particularly those related to AI and human reader performance, are not applicable to this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for various performance metrics in a readily quantifiable format. Instead, it refers to a Material Approval File (MAF) and mechanical testing.
Acceptance Criteria (Inferred from Performance Data Section):
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material and Structural Properties of Washer | Suitable for the intended use of the device (MAF#920) | Demonstrated suitability in MAF#920 |
| Strength of CP Titanium/Hedrocel® Interface | Sufficient for the intended use (implied, demonstrated through mechanical testing) | Mechanical testing included in 510(k) demonstrated sufficient strength |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The term "test set" in the context of device performance usually refers to the specimens used for mechanical or material testing. The document states "Mechanical testing demonstrating the strength of the CP Titanium/Hedrocel® interface is included in this 510(k) Premarket Notification," but does not detail the sample size or provenance of these tests.
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)
This is not applicable as the study described is a mechanical/material performance study, not a study requiring expert interpretation of results to establish ground truth in the way clinical or AI studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for clinical studies or those involving human interpretation, not mechanical testing.
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 device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the direct physical measurement of material properties and interface strength against established engineering standards or internal specifications for safety and performance in its intended use. It is based on direct physical measurement and engineering principles.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm requiring a training set.
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FEB
510(k) SUMMARY Implex Screw and Washer System
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | John Schalago, RAC or Robert Poggie, Ph.D. |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | January 27, 1999 |
| Device Trade Name: | Implex Screw and Washer System |
| Device Common Name: | Washer, bolt, nut |
| Classification Number | 21 CFR § 878.3030 |
| SubstantialEquivalence: | The term "substantial equivalence" as used in this510(k) notification is limited to the definition ofsubstantial equivalence found in the Federal Food,Drug and Cosmetic Act, as amended and as appliedunder 21 CFR 807, Subpart E under which a devicecan be marketed without premarket approval orreclassification. A determination of substantialequivalency under this notification is not intendedto have any bearing whatsoever on the resolution ofpatent infringement suits or any other patentmatters. No statements related to, or in support ofsubstantial equivalence herein shall be construedas an admission against interest under the USPatent Laws or their application by the courts. |
|---|---|
| ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Device Description: The Implex Screw and Washer System consists of the Implex Continuum Bone Screw configured with a Hedrocel®/CP titanium Washer. The Implex Continuum Bone Screw has a 5 mm diameter and is offered in lengths from 15 to 65 mm, in 5 mm increments. The Washer is offered in two versions. Washer-A and Washer-A has a flat tissue-contacting Washer-B. surface and Washer-B has a flat tissue-contacting surface with recessed grooves. Both versions are round, and offered in three outer diameters, 14 mm, 17 mm, and 20 mm.
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510(k) Summary of Safety and Effectiveness (continued)
,
| Indications for Use: | The Implex Screw and Washer System is indicatedfor use in the attachment of ligaments, tendons andother soft tissue to bone. |
|---|---|
| Device TechnologicalCharacteristics andComparison toPredicate Device: | The Hedrocel® Screw and Washer System has thesame intended use and indications for use, and isoffered in equivalent geometries and sizes as thepredicate devices. |
| Performance Data: | Performance data provided in MAF#920demonstrates that material and structural propertiesof the washer component of the Implex Screw andWasher System are suitable for the intended use ofthe device. The screw is a currently legally marketedbone screw. Mechanical testing demonstrating thestrength of the CP Titanium/Hedrocel® interface isincluded in this 510(k) Premarket Notification. |
| Predicate DeviceInformation: | The predicate device cited in this premarketnotification to support a determination of substantialequivalence are the Implex Continuum® Bone Screw,the MDLI Soft Tissue Screw and Washer System, andthe Mitek Screw and Washer System. |
| Conclusion: | The Implex Screw and Washer System issubstantially equivalent to the identified predicatedevices. |
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | 1 1999
John A. Schalago, RAC Requlatory Affairs Manager Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey
Re: K982751 Implex Corporation Screw and Washer System Trade Name: Regulatory Class: II Product Codes: MBI and HWC Dated: November 3, 1998 November 4, 1998 Received:
Dear Mr. Schalago:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations.
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Page 2 - John A. Schalago, RAC
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.
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden for
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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510(k) Number (if known): 2 1 5 1
Implex Screw and Washer System Device Name:
Indications For Use:
The Implex Screw and Washer System is indicated for use in the ligaments, tendons and other soft tissue to attachment of bone .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
OR...
Over-The-Counter Use
(Optional Format 1-2-96)
fo
(Division Sign-Off) Division of Ceneral Restorative Devices 982 510(k) Number_ ﮨﮯ۔ 5
N/A