(83 days)
The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).
The SmartScrew ACL™ a fully threaded, cannulated interference screw with slightly tapered head and tip. SmartScrew ACL™ is provided with three different diameter, 7.0, 8.0 and 9.0mm and with three lengths, 20, 25 and 30mm and it is made of poly-L/D-lactide copolymer.
This document, K993073 for the SmartScrew ACL™, is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed studies proving specific acceptance criteria. Therefore, the requested information about acceptance criteria and detailed study results is largely not present within this document.
Here's what can be inferred and what is missing based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. The summary indicates that the SmartScrew ACL™ "has the same intended use, principles of operation and technological characteristics than predicate devices," implying that it is expected to perform similarly to those already approved devices. However, explicit acceptance criteria (e.g., specific tensile strength, degradation rates, biocompatibility metrics) and the SmartScrew ACL™'s performance against those criteria are not detailed.
2. Sample size used for the test set and the data provenance:
This information is not provided. 510(k) summaries for devices cleared based on substantial equivalence to predicates often do not include specific test set sizes or details about data provenance if no new clinical or performance studies were required. The focus is on comparing the new device's characteristics to the predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. This level of detail would typically be found in a detailed study report, which is not part of this 510(k) summary.
4. Adjudication method for the test set:
This information is not provided. Adjudication methods are relevant for studies involving subjective assessments, usually in clinical trials, which are not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The SmartScrew ACL™ is a medical device (an interference screw for ligament reconstructions), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As mentioned above, this is a physical medical device, not an algorithm.
7. The type of ground truth used:
This information is not explicitly stated. For a device like an interference screw, "ground truth" might refer to in-vitro biomechanical testing results (e.g., pull-out strength, stiffness), material characterization (e.g., degradation profiles), and biocompatibility testing. The summary mentions "minor technological differences... do not raise any new issues of safety or effectiveness," suggesting that standard testing (likely non-clinical) was performed to ensure safety and equivalence, but specific details about what this "ground truth" entailed are absent.
8. The sample size for the training set:
This information is not provided. This concept is typically relevant for machine learning algorithms, which is not the case for this device.
9. How the ground truth for the training set was established:
This information is not provided. Again, this concept is primarily relevant for machine learning algorithms.
In summary of the provided document (K993073):
The 510(k) summary for the SmartScrew ACL™ primarily relies on demonstrating substantial equivalence to existing predicate devices (Phantom PLLA Interference Screw, Resorbable Interference Screw, BioScrew Fixation System, etc.) rather than presenting detailed data from studies designed to prove specific acceptance criteria for the new device in isolation. The document states:
- "The SmartScrew ACL™ has the same intended use, principles of operation and technological characteristics than predicate devices."
- "Furthermore, the minor technological differences between the SmartScrew ACL™ and the predicate devices do not raise any new issues of safety or effectiveness."
This means that the "acceptance criteria" are implicitly met by demonstrating that the device is fundamentally similar to other devices already deemed safe and effective by the FDA. Specific performance metrics and study designs are not elaborated upon in this type of submission summary.
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DEC - 6 1999
510(k) Summary Bionx Implants Inc. SmartScrew ACL™
Submitter´s Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422
| Contacts: | Gerard S. CarlozziPresident and Chief Operating Officer |
|---|---|
| Phone: (215) 643-5000 | |
| Facsimile: (215) 653-0984 | |
| Bionx Implants Ltd. | |
| Tuija AnnalaRegulatory Affairs Assistant | |
| P.O.Box 3 | |
| FIN-33721 Tampere | |
| Finland | |
| Phone: 358-3-316 5679 | |
| Facsimile: 358-3-316 5688 | |
| Date prepared: | August 24th, 1999 |
| Name of the device: | |
| A. Trade or Proprietary Name: | SmartScrew ACLTM |
| B. Common Name: | Bioabsorbable Interference Screw |
| C. Classification Name: | Biodegradable fixation fastener, bone and soft tissue |
| D. Device Product Code: | HWC and MAI |
| Predicate Devices: | |
| DePuy, Inc. | Phantom PLLA Interference Screw (K955733)Resorbable Interference Screw (K981670)Phantom Resorbable Interference Screw (K982662) |
| Linvatec Corporation | BioScrew Fixation System (K933719, K952831, K973758) |
| Instrument Makar, | Biologically Quiet Interference Screw (K943249) |
| Biomet, Inc. | Arthrotek Interference Screw (K982496) |
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K095073
2 of 2
| Arthrex, Inc. | The Arthrex Bio-Interference Screw (K971358) |
|---|---|
| Tornier S.A | Phusis Absorbable Interference Screw (K970829) |
| Acufex Microsurgical,Inc | Acufex Endofix Absorbable Interference Screw(K954246) |
| Smith and Nephew, Inc. | Bioabsorbable Interference Screw (K984320) |
| Sulzer Orthopedics, Inc. | Sysorb Interference Screw (983592) |
Intended Use:
The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
Device Description:
The SmartScrew ACL™ a fully threaded, cannulated interference screw with slightly tapered head and tip. SmartScrew ACL™ is provided with three different diameter, 7.0, 8.0 and 9.0mm and with three lengths, 20, 25 and 30mm and it is made of poly-L/D-lactide copolymer.
Substantial Equivalence:
The SmartScrew ACL™ has the same intended use, principles of operation and technological characteristics than predicate devices.
In summary, the SmartScrew ACL™ is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the SmartScrew ACL™ and the predicate devices do not raise any new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC -6 1999
Mrs. Tuija Annala Regulatory Affairs Assistant Bionx Implants Limited P.O. Box 3 FIN-33721 Tampere Finland
Re: K993073 SmartScrew ACL™ Bioabsorbable Trade Name: Interference Screw Requlatory Class: II Product Codes: MAI and HWC Dated: August 23, 1999 Received: September 14, 1999
Dear Mrs. Annala:
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 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 Requlations, 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 Requlation (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.
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Page 2 - Mrs. Tuija Annala
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 RP Ogden
Jámes E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number (if known): _ K993073
Device Name:
SmartScrew ACLTM
Indications for Use:
The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
Neo for
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.