(148 days)
- The BioScrew is used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference fixation during posterior cruciate ligament reconstruction.
Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.
The BioScrew Absorbable Interference Screw is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
The provided text focuses on the 510(k) premarket notification for the BioScrew® Absorbable Interference Screw. It establishes substantial equivalence to predicate devices and describes the device's intended use and characteristics. However, it does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics (e.g., accuracy, sensitivity, specificity) typically associated with diagnostic or AI-driven medical devices.
Instead, the "acceptance criteria" for this device, as implied by the FDA 510(k) process, are met through demonstrating:
- Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device. This is the primary "acceptance criterion" for a 510(k) submission.
- Compliance with General Controls: Meeting requirements for annual registration, device listing, good manufacturing practices (GMP), labeling, and prohibitions against misbranding and adulteration.
The "study" that proves the device meets these generalized acceptance criteria for a 510(k) is the comparison to legally marketed predicate devices.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for an interference screw, the "performance" is primarily defined by its physical characteristics and intended use being substantially equivalent to existing devices. There are no quantitative performance metrics like accuracy, sensitivity, or specificity that would typically be reported for a diagnostic device.
| Acceptance Criterion (Implicit for 510(k) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Material Composition | BioScrew® Absorbable Interference Screw: Poly (L-lactic Acid) - Similar to predicate BioScrew® and bioabsorbable suture. Others (Arthrex, BioMet) use Titanium. |
| Intended Use | BioScrew® Absorbable Interference Screw: Provide interference fixation for patellar bone-tendon-bone grafts in ACL reconstruction, femoral/tibial fixation in ACL reconstruction using soft tissue graft, and PCL reconstruction. - Substantially equivalent to predicate devices. |
| Design | BioScrew® Absorbable Interference Screw: Cannulated, Headless & rounded head, Diameter: 7mm-11mm, Length: 20mm-30mm. - Similar to predicate devices, with slight variations in diameter range compared to some predicates, but within general range. |
| Single-Use/Reusable | BioScrew® Absorbable Interference Screw: Sterile Single-use - Similar to predicate devices. |
| Method of Sterilization | BioScrew® Absorbable Interference Screw: Ethylene Oxide, 24 month shelf life - Similar to predicate BioScrew®. |
| Safety and Effectiveness | Demonstrated through substantial equivalence to legally marketed predicate devices (Linvatec BioScrew Absorbable Interference Screw, Arthrex Interference Screws, Arthrotek Interference Screws). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" with a sample size for performance evaluation in the way one might for an AI algorithm or a diagnostic assay. The "test" here is the comparison of the new device's features and intended use against predicate devices based on existing regulatory clearances.
- Sample Size for Test Set: Not applicable in the context of device performance testing for this 510(k). The "test" is a qualitative comparison to existing devices.
- Data Provenance: Not applicable. The "data" primarily consists of the specifications of the new device and the predicate devices, as described in their respective 510(k) submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The assessment of substantial equivalence is conducted by FDA reviewers (e.g., in the Division of General and Restorative Devices) based on submitted documentation, not by external experts establishing "ground truth" for a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" and thus no adjudication method for establishing ground truth in the way described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a 510(k) submission for an absorbable interference screw, which is a physical implant. MRMC studies are typically used for evaluating diagnostic imaging systems or AI algorithms with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is not an algorithm or a diagnostic tool.
7. The Type of Ground Truth Used
The "ground truth" for a 510(k) is implicitly the regulatory clearance and established safety and effectiveness of the predicate devices. The new device is deemed "safe and effective enough" if it is substantially equivalent to these already-cleared devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI algorithm.
In summary, the provided document is a 510(k) premarket notification. The "acceptance criteria" and "study" for this type of submission revolve around demonstrating substantial equivalence to predicate devices, rather than meeting quantitative performance metrics derived from a specific test set, as would be the case for a new diagnostic or AI-powered solution. The document explicitly states: "Strength and degradation tests are planned to compare the BioScrew to the Arthrex and/or BioMet screws," indicating that future comparative testing was intended, but the 510(k) clearance itself was based on the substantial equivalence argument, not necessarily the results of those planned tests at the time of submission.
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11311 Concept Boulevard - Largo, Florida - 3773 - 813 399-5334 - Fax 813 399-5264
Carol A. Weideman, Ph.D.
Director Regulatory Affairs
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October 1, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
BioScrew® Absorbable Interference Screw
In accordance with the requirements of the Safe Medical In accordance #1ch and 21 CFR 807.92, Linvatec Corporation Device Hot of itting the 510(k) Summary of Safety and Absorbable Interference Effectiveness for the BioScrew® Screw.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Company Contact B.
Carol A. Weideman, Ph.D. Director, Regulatory Affairs
Device Name C.
BioScrew® Absorbable Interference Screw Trade Name : Bone Screw Common Name: Smooth or threaded metallic bone Classification Name: fixation fastener
Predicate/Legally Marketed Devices D.
Linvatec BioScrew Absorbable Interference Screw Arthrex Interference Screws Arthrotek Interference Screw
Device Description E .
The BioScrew Absorbable Interference Screw is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
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Summary of Safety and Effectiveness BioScrew® Absorbable Interference Screw 510 (k) # _ K973758 October 1, 1997 Page 2 of 3
Intended Use F.
- The BioScrew is used to provide interference 1. fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference 2. fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference 3. fixation during posterior cruciate ligament reconstruction.
Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.
Substantial Equivalence G.
The BioScrew Absorbable Interference Screw is substantially equivalent in design, function and intended use to Linvatec BioScrew Absorbable Interference Screw, Arthrex Interference Screws and Arthrotek Interference Screws.
Strength and degradation tests are planned to compare the BioScrew to the Arthrex and/or BioMet screws.
The similarities/dissimilarities to the predicate are shown in the attached table.
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CHART OF SIMILARITIES AND DISSIMILARITIES
(
| Company Name | Device Name | Intended Use | Material | Single-UseReusable | Method ofSterilization | Design |
|---|---|---|---|---|---|---|
| New ProductInvatec | BioScrew®AbsorbableInterferenceScrew | Provide interference fixation:1. Patellar bone-tendon-bonegrafts in ACL reconstruction2. Femoral and/or tibialfixation in ACLreconstruction using a softtissue graft3. PCL reconstruction | Poly(L-lactic Acid) | SterileSingle-use | EthyleneOxide24 monthshelf life | CannulatedHeadless & roundedheadDiameter: 7mm-11mmLength: 20mm-30mm |
| PredicateInvatec | BioScrew®AbsorbableInterferenceScrew510(k) #K960652#K960940 | Provide interference fixation:1. Patellar bone-tendon-bonegrafts in ACL reconstruction2. Femoral and/or tibialfixation in ACLreconstruction using a softtissue graft3. PCL reconstruction | Poly(L-lactic Acid) | SterileSingle-use | EthyleneOxide24 monthshelf life | CannulatedHeadless and roundedheadDiameter: 7mm-9mmLength: 20mm-30mm |
| PredicateArthrex,Inc. | Non-sheathedInterferenceScrewsFull ThreadedScrews510(k) #K915424 | Tibial ACL fixation, PCLfemoral and tibial fixation andstandard two incision type ACLprocedures | Titanium | SterileSingle-use | Unknown | CannulatedHeadless and roundedheadDiameter: 6mm-10mmLength: 20mm-30mm |
| PredicateBioMet,Inc. | ArthrotekInterferenceScrew510(k) #K934469 | Interference fixation ACL andPCL reconstruction | Titanium | Sterile ornon-sterileSingle-use | Unknown | Rounded headDiameter: 7mm-10mmLength: 20mm-30mm |
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB < 7 1998
Carol A. Weideman, Ph.D. Director, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K973758 BioScrew® Absorbable interference Screw Regulatory Class: II Product Codes: HWC and MAI Dated: January 19, 1998 Received: January 20, 1998
Dear Dr. Weideman:
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 (OS) 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 - Carol A. Weideman, Ph.D.
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,
Cella 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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LINVATEC/HALL SUSGICAL PHOPRIETARY INFORMATION
This information is exempt from
disclosure under Exemptions 3 and 4 11311 Concept Boulevard Largo, Florida 737734908 8139264665 11:5 Freedom of Information Act
October 1, 1997 Date:
Page 1 of 1
510(k) Number (if known): K973758
BioScrew® Absorbable Interference Screw Device Name:
Indications for Use:
- The BioScrew is used to provide interference fixation 1. of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference fixation 2. during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference fixation 3. during posterior cruciate ligament reconstruction.
Implantation of the interference screw is accomplished This device is a singlethrough arthroscopy or arthrotomy. use device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED }
Concurrence of CDRH, Office of Device Evaluation (ODB)
Prescription Use \$\times$_
OR
Over-the-Counter Use _
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973758(Optional Format 1-2-96)
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A Bristol-Myers Squibb Company
§ 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.