(182 days)
The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:
- places the graft in tibial and/or femoral tunnels; and .
- inserts screws between the tunnel wall and graft to hold the graft in place. .
The BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
The BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP and poly (L-lactide) (PLLA).
The provided document is a 510(k) summary for the BioLok® Screw, a medical device. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not typically include information about clinical trials, extensive performance studies, or AI-related aspects like multi-reader multi-case studies, ground truth establishment for training data, or sample sizes related to AI model development.
Based on the provided information, I can answer the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the format typically seen for rigorous performance metrics (e.g., specific thresholds for strength, pull-out force, etc.). Instead, the performance data provided is comparative.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Requisite strength over time for early and sustained graft fixation. | Test results confirm this. |
| Favorable pull-out test results compared to predicate devices. | Pull-out test results compare favorably with predicate devices. |
| Equivalence in design, materials, and indications to predicate devices. | The BioLok® Screw is equivalent in design, materials, and indications to the predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any mechanical or performance tests. It also does not mention data provenance (e.g., country of origin, retrospective/prospective) for any test data.
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. The device is a bone fixation screw; its performance is evaluated through mechanical testing, not by expert interpretation of images or data requiring ground truth establishment in the way an AI diagnostic device would.
4. Adjudication method for the test set
This information is not applicable and not provided. The evaluation of mechanical test results does not typically involve adjudication methods like those used for expert consensus in clinical trials or diagnostic studies.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. The BioLok® Screw is a physical surgical implant, not an AI diagnostic tool.
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 BioLok® Screw is a physical device, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data, expert consensus on images) is not directly applicable here. The "ground truth" for a mechanical device like the BioLok® Screw would be the objective measurements of its physical and mechanical properties and its performance in specific tests (e.g., force required for pull-out, material degradation rates). The document states "Test results confirm that this composite has the requisite strength over time" and "Pull out test results compare favorably with the predicate devices," implying these mechanical test outcomes are the basis for evaluation.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" as the device is not an AI model.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for an AI model.
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510(k) Summary of Safety and Effectiveness
| (1) | Submitter's name: | Encore Orthopedics, Inc. |
|---|---|---|
| Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 | |
| Submitter's telephone number: | 512) 834-6237 | |
| Contact person: | Debbie De Los Santos | |
| Date summary prepared: | October 14, 1999 | |
| (2) | Trade or proprietary device name: | BioLok® Screw |
| Common or usual name: | Bone Fixation Screw | |
| Classification name: | Class II | |
| (3) | Legally marketed predicate device: | Bio Interference Screw (Arthrex) |
| BioScrew (Linvatec) |
Subject device description: (4)
The BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP and poly (L-lactide) (PLLA).
(ર) Subject device intended use:
The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:
- places the graft in tibial and/or femoral tunnels; and .
- inserts screws between the tunnel wall and graft to hold the graft in place. .
The BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
Technological characteristics: (6)
The BioLok® Screw has the same technological characteristics (i.e., design and material) when compared to the predicate devices.
(7) Performance data:
Test results confirm that this composite has the requisite strength over time to provide early and sustained fixation of the graft. Pull out test results compare favorably with the predicate devices.
Basis for substantial equivalence: (8)
The BioLok® Screw is equivalent in design, materials and indications to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2000
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758
Re: K993630
Trade Name: BioLok® Screw Regulatory Class: II Product Code: HWC Dated: February 4, 2000 Received: February 7, 2000
Dear Ms. Los Santos:
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 control provisions of the Act. The general control 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 - Ms. Debbie De Los Santos
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,
ymne R. lichner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ______________________________________________________________________________________________________
Indications For Use:
BioLok® Screw
Indications For Use
The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:
- places the graft in tibial and/or femoral tunnels; and .
- inserts screws between the tunnel wall and graft to hold the graft in place. ●
The BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dams R. Lochner.
(Division S
Restorative Devices
number K993630
Prescription Use _ V (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.