(17 days)
a) General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques.
b) Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below.
- Primary total hip arthroplasty.
- Revision total hip arthroplasty.
- Any procedure using anterolateral or lateral approaches.
The Smith & Nephew Orthopaedic Cabling System consists of: a cable with or without clamps or swages; trochanteric grips with or without clamp plates.
The provided document is a 510(k) Premarket Notification for a medical device (Smith & Nephew Orthopaedic Cabling System) seeking substantial equivalence to legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, which would typically be found in an AI/algorithm-based device submission.
Instead, this document focuses on demonstrating substantial equivalence for a physical orthopedic cable system, which involves comparing its intended use, materials, design, and operational principles to existing devices. Therefore, the questions related to AI/algorithm performance, sample sizes for test/training sets, experts, and adjudication methods are not applicable to this type of submission.
Here's an attempt to answer the relevant aspects based on the provided text, while explicitly stating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
For a physical device like an orthopedic cable system, "acceptance criteria" and "reported device performance" are typically related to mechanical properties, biocompatibility, and manufacturing quality, rather than statistical performance metrics (e.g., accuracy, sensitivity) for an AI. These specific criteria and performance values are not detailed within this 510(k) summary. The summary focuses on establishing equivalence in:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use Equivalence | Intended uses are identical or very similar to predicate devices: general orthopaedic repair procedures and trochanteric reattachment. |
| Materials Equivalence | Uses materials similar to predicate devices (cables, clamps/swages, trochanteric grips). |
| Design Equivalence | Design is similar to predicate devices (features cables, clamps/swages, trochanteric grips). |
| Operational Principles Equivalence | Uses similar technology to achieve proper bone fracture fixation as predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical orthopedic implant, not an AI/algorithm. There is no "test set" in the context of evaluating an algorithm's performance on data. The evaluation is against predicate devices.
3. 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)
Not applicable. There is no 'ground truth' establishment in the context of an AI/algorithm test set for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for an AI/algorithm. For a physical device, the "ground truth" would implicitly be established through engineering specifications, biomechanical testing, and clinical experience with equivalent predicate devices to ensure safety and effectiveness. These specific studies are not detailed in this 510(k) summary but would be part of the full submission.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm device.
Summary of the study conducted (as implied by a 510(k) for a physical device):
The "study" or evaluation for this device is a demonstration of substantial equivalence to legally marketed predicate devices. This involves a comprehensive comparison of:
- Intended Use: The indications for use for the Smith & Nephew Orthopaedic Cabling System (general orthopaedic repair procedures, including specific fracture types and trochanteric reattachment) are presented and compared to those of existing, legally marketed predicate devices.
- Technological Characteristics: The device's design (cable with or without clamps/swages, trochanteric grips) and operational principles (similar technology for tension, compression, and locking) are described and asserted to be similar to predicate devices.
- Materials: While not explicitly detailed, it's implied that the materials used are common for such devices and comparable to those in predicate devices.
Predicate Devices Used:
The Smith & Nephew Orthopaedic Cabling System claims substantial equivalence to:
- Smith & Nephew's Orthopaedic Cable Systems (K842977, K875156, K924141)
- Biomet's BMP Cable System (K982545)
- Howmedica's Dall-Miles Cable System (K971741)
- Pioneer's Cerclage Cable with Hex Button (K974016)
- Zimmer's Cable-Ready Cable Grip System
The 510(k) process for a Class II device like this relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than requiring new clinical trials to prove efficacy from scratch.
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MAY - 1 2003
Smith & Nephew, Inc. Summary of Safety and Effectiveness: Orthopaedic Cable
Contact Person and Address
Date of Summary: April 11, 2003
Kanu Vadodaria Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc., Orthpopaedics Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6261
page 1 of 1
Name of Device: Smith & Nephew Orthopaedic Cable Common name: Orthopedic Cabling system
Device Classification name:
21 CFR 888.3010 Bone fixation cerclage - Class II
Substantially Equivalent Legally Marketed Devices
The substantial equivalence of the Smith & Nephew Orthopaedic Cabling System is based on the equivalence in intended use, materials, design, operational principles and indications to the following predicate devices - Smith & Nephew's Orthopaedic Cable Systems (K842977, K875156, K924141), Biomet's BMP Cable System (K982545), Howmedica's Dall-Miles Cable System (K971741), Pioneer's Cerclage Cable with Hex Button (K974016), and Zimmer's Cable-Ready Cable Grip System.
Device Description
The Smith & Nephew Orthopaedic Cabling System consists of: a cable with or without clamps or swages; trochanteric grips with or without clamp plates.
Indications for Use:
Cable Implants:
General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, fixation of spiral fractures in conjunction with intra-medullary nailing and screwing fixation techniques.
Trochanteric Grips:
Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below:
- Primary total hip arthroplasty. 1.
-
- Revision total hip arthroplasty.
-
- Any procedure using anterolateral or lateral approaches.
Technological and Performance Characteristics:
All predicate devices use cables, swages (clamps) and trochanteric grips as a system for bone fracture fixation. Each system uses accessory instruments to provide proper tension and compression to lock the cable. The Smith & Nephew Orthopaedic Cabling System uses similar technology to achieve proper bone fracture fixation.
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Image /page/1/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. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2003
Mr. Kanu Vadodaria Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K031162
Trade/Device Name: Smith & Nephew Orthopaedic Cabling System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: April 11, 2003 Received: April 14, 2003
Dear Mr. Vadodaria:
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 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.
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Page 2 - Mr. Kanu Vadodaria
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) 594-4659. 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 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,
Sincerely yours,
Mark A. Millan
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 Statement Smith & Nephew Orthopaedic Cabling System
510(k) Number (if known): K031162
Device Name: Smith & Nephew Orthopaedic Cabling System
Indications for Use:
- a) General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques.
- b) Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below.
-
- Primary total hip arthroplasty.
-
- Revision total hip arthroplasty.
-
- Any procedure using anterolateral or lateral approaches.
-
(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 (Optional Format 1-2-96)
Mark A. Milkerson
Division Sign-City Division of General, Restorative and Neurological Devices
510(k) Number 5/1/03
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.