(18 days)
The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
The Modified BioRCI® Screw is an interference screw in the range of 7-12mm in diameter and 20-35mm in length.
The provided document is a 510(k) summary for the BioRCI® Screw Modification, a bone fixation screw. It does not describe an AI/ML powered device or a study involving human readers and AI assistance.
Therefore, I cannot provide details on acceptance criteria and a study proving device performance in the context of AI/ML, human readers, or related metrics.
The document discusses the substantial equivalence of the modified device to a predicate device based on traditional medical device manufacturing and performance testing.
Here's an analysis of what is provided, framed by your request, showing why AI/ML specific information is absent:
-
A table of acceptance criteria and the reported device performance:
The document states: "In vitro performance testing, material biocompatibility and sterilization validation demonstrate the modified device is safe, substantially equivalent and performs as intended."
It does not provide a table with specific quantitative acceptance criteria (e.g., tensile strength thresholds, biocompatibility indices) or the exact numerical results from these tests. It only makes a summary statement that these tests demonstrate "safe, substantially equivalent and performs as intended." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "in vitro performance testing," but does not specify the sample sizes (e.g., number of screws tested) for these tests, nor the data provenance beyond "in vitro." It's highly likely these were laboratory tests conducted by the manufacturer. -
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 to traditional in-vitro performance testing of a bone fixation screw. "Ground truth" in this context would be defined by engineering specifications and material science standards, not expert medical opinion on an output. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in image interpretation or diagnostic studies involving human consensus, not for mechanical testing of a screw. -
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:
No, a MRMC comparative effectiveness study was not done. This device is a physical bone fixation screw, not an AI diagnostic or assistive tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For "in vitro performance testing," the ground truth would be established by engineering specifications, material properties, and relevant ASTM or ISO standards for medical devices (e.g., strength requirements, material composition standards). For "biocompatibility," ground truth is established by ISO 10993 standards and related testing for biological response. For "sterilization validation," ground truth is established by standards like ISO 11135 or 11137. -
The sample size for the training set:
This is not applicable. The device is a physical screw, not an AI/ML model that requires a training set. -
How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical medical device.
In summary, the provided information relates to the regulatory submission for a physical medical device (a bone fixation screw) and, as such, does not contain the AI/ML specific information requested.
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AUG 0 8 2003
K03 2224
page 1 of 2
EXHIBIT C
Endoscopv Division
Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810 U.S.A. Telephone: (978) 749-1000 Fax: (978) 749-1443
Smith - Nephew
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as
equired by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon vhich the substantial equivalence is based.
BioRCI® Screw Modification
Date Prepared: 18 July 2003
4. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Marion W. Gordon, RAC Regulatory Affairs Specialist Phone: 978-749-1371 Fax: 978-749-1443
C. Device Name
Trade Name: Common Name: Classification Name: BioRCI® Screw Bone fixation screw Smooth or metallic bone fixation fastener per 21 CFR § 888.3040
D. Predicate Devices
The Smith & Nephew Modified BioRCI® Screw is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution: BioRCI® Screw, K992396.
E. Description of Device
The Modified BioRCI® Screw is an interference screw in the range of 7-12mm in diameter and 20-35mm in length.
BioRCI® Screw Page 34 of 35
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032224
page 2 of 2
F. Intended Use
The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
G. Comparison of Technological Characteristics
The Modified BioRCI® Screw incorporates a substantially equivalent design, using the same material, manufacturing, fundamental scientific technology, packaging, labeling, sterilization, and intended use as those featured in the currently commercialized BioRCI® Screw line.
H. Summary Performance Data
In vitro performance testing, material biocompatibility and sterilization validation demonstrate the modified device is safe, substantially equivalent and performs as intended.
BioRCI® Screw Page 35 of 35
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird.
Public Health Service
AUG - 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marion W. Gordon, RAC Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, MA 01810
Re: K032224
Trade/Device Name: BioRCI® Screw Modification Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 18, 2003 Received: July 21, 2003
Dear Ms. Gordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Marion W. Gordon, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
( 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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Indications for Use
510(k) Number (if known):
Ko32224
Device Name: ___ BioRCI® Screw Modification
Indications For Use:
The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032224
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
BioRCI® Screw Page 10 of 35
§ 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.