(73 days)
The Biosteon™ 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 Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.
The Biosteon™ 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 Biosteon™ 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 Biosteon™ Screw is manufactured from a mixture of Hydroxyapatite (HA) and poly (L-lactide) (PLLA).
The provided 510(k) summary for the Biosteon™ Screw (K003641) does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific quantitative acceptance criteria in the way described in your request (e.g., sensitivity, specificity, or other performance metrics typically associated with AI/software-as-a-medical-device studies).
This document pertains to a physical medical device (an absorbable bone screw), not an AI/software device. Therefore, many of the requested fields, such as those related to AI model performance, expert ground truth, sample sizes for test/training sets, and MRMC studies, are not applicable in this context.
Here's an attempt to extract and interpret the available information according to your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Requisite strength for early and sustained graft fixation | Test results confirm this composite has the requisite strength. |
| Favorable pull-out test results compared to predicate devices | Pull out test results compare favourably with the predicate devices. |
| Equivalence in design, materials, and indications to predicate devices | Biosteon™ Screw is equivalent in design, materials and indications to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "Test results" but does not quantify the number of units tested.
- Data Provenance: Not applicable in the context of human data. The tests are laboratory-based mechanical performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device; ground truth for its mechanical properties is established through standardized engineering tests, not expert human assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication method is described or implied for the mechanical testing of the screw.
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. No MRMC study was conducted as this is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing Results / Engineering Standards: The ground truth for the device's performance (strength, pull-out force) would be derived from laboratory measurements against established engineering specifications or benchmarks set by predicate devices.
8. The sample size for the training set
- Not Applicable. This is not a machine learning/AI device, so there is no training set in the AI sense. The "training" for the device's design would come from materials science research and iterative design processes.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Device Performance Study (as described in the 510(k) summary):
The 510(k) summary indicates that the substantial equivalence of the Biosteon™ Screw to predicate devices (Bio Interference Screw, BioScrew, BioLok® Screw) was supported by performance data, specifically mechanical testing.
- Study Design (Implied): Comparative mechanical testing.
- Primary Outcome: Confirmation of "requisite strength to provide early and sustained fixation of the graft" and "favourable pull out test results" when compared to predicate devices.
- Test Method (Implied): Mechanical assays such as tensile strength, compression, and pull-out force tests, likely conducted in a laboratory setting using surrogate materials or cadaveric models that mimic the surgical environment.
- Results: The device demonstrated "requisite strength" and "favourable pull out test results" compared to its predicates. This satisfied the FDA's requirement for demonstrating substantial equivalence based on technological characteristics and performance.
Conclusion:
The provided document describes the safety and effectiveness of a physical bone fixation screw. The "study" mentioned refers to mechanical performance testing, which is common for such devices. It does not involve any AI components, human readers, or the complex validation methodologies associated with AI-driven medical devices. The acceptance criteria are implicitly met by demonstrating comparable mechanical performance to legally marketed predicate devices.
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510(K) Summary of Safety and Effectiveness
FEB = 8 2001
-
(1) Submitter's name: Submitter's address:
Submitter's telephone number: Contact person: Date summary prepared: -
(2) Trade or proprietary device name: Common or usual name: Classification name:
Legally marketed predicate device:
Biocomposites Ltd Etruscan Street, Etruria, Stoke-on-Trent, ST1 5PQ, England 44 (0) 1782 206500 Stephen Bratt 22 November 2000
Biosteon™ Screw Bone Fixation Screw Class II
Bio Interference Screw (Arthrex) BioScrew (Livatec) BioLok® Screw (Biocomposites)
(4) Subject device description:
(3)
The Biosteon™ 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 Biosteon™ Screw is manufactured from a mixture of Hydroxyapatite (HA) and poly (L-lactide) (PLLA).
(5) Subject device intended use:
The Biosteon™ 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 Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.
The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
(6) Technological characteristics:
The Biosteon™ 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 to provide early and sustained fixation of the graft. Pull out test results compare favourably with the predicate devices.
(8) Basis for substantial equivalence:
The Biosteon™ 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 & Human Services. The logo features a stylized eagle-like design with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
FEB - 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J. Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Etruria Stoke-on-Trent Staffordshire, ST1 5PQ United Kingdom
Re: K003641
Trade Name: Biosteon™ Screw Regulatory Class: II Product Code: HWC Dated: November 22, 2000 Received: November 27, 2000
Dear Mr. Bratt:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave 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 stated in the enorouse) to certice Amendments, or to devices that have been reclassified in enacinent ante of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provident to the general control provisions of the Act. The general therefore, market 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 ( Fenance . Ipple any 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 mspootions, the Food and may result in regulatory action. In addition, FDA may publish compy was and One over ing 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. J. Stephen Bratt
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the officing additionally 809.10 for in Villo diagnostic ac nows, promotion and advertising of your device, and device, and (301) 594-4659. Additionally, for questions on the presente the regulation please contact the Office of Comphance at (301) 977 Vestion" (21 CFR 807.97). Other general entitled, "Misbranding by telefice under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the 100 m information on your responsibilities under in Archile, 68 code 1 or (301) 443-6597 or at its
Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 Manufacturers "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L. Mark N. Mulkerson
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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Biosteon™ Screw
Indications For Use
The Biosteon™ 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 Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.
The Biosteon™ Screw is used to provide interference fixation during femoral and/or The Diostcon in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
L. Mark N. Millman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K003641
§ 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.