(30 days)
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
PERI-LOC Ankle Fusion Bone Plates and the VLP Extra Large Percutaneous Calcaneus Plate are for single use only.
The subject devices are comprised of implantable, locking bone plates and a device specific instrument. All described implants are manufactured from implant grade stainless steel material. The subject implant devices are available in the following sizes:
| Device Type | Available Length |
|---|---|
| PERI-LOC 3.5mm Ankle Fusion Plates, Anterior Primary,LH/RH with Compression Slot, 3H | 67mm |
| PERI-LOC 3.5mm Ankle Fusion Plates, Anterior Primary,LH/RH with Compression Slot, 5H | 92mm |
| PERI-LOC 3.5mm Hindfoot Ankle Fusion Utility Plates,LH/RH with Compression Slot, 5H | 104mm |
| VLP 2.7mm Percutaneous Calcaneus Plates, Extra Large, LH/RH | 68mm |
A new device specific instrument is also described in this Special 510(k) premarket notification in select sections and exhibits.
The provided text [K120667](https://510k.innolitics.com/search/K120667) is a 510(k) summary for medical device clearance, specifically for orthopedic implants (bone plates). It does not contain information typically associated with the acceptance criteria and study results for AI/ML-based diagnostic or prognostic devices.
The acceptance criteria and study details requested in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are characteristic of studies evaluating the performance of AI algorithms.
The provided document refers to:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a performance study in the AI/ML sense.
- Pre-clinical evaluation: A pre-clinical evaluation was conducted, but the document only states "Results were compared against previously cleared PERI-LOC Ankle Fusion Plate predicate devices" without detailing the acceptance criteria, specific measures, or results. This is likely mechanical testing or similar engineering validation, not a clinical study to establish diagnostic performance.
- Intended Use: describes the medical purpose and patient population.
- Technological Characteristics: compares the device to predicates.
Therefore, I cannot extract the requested information as it is not present in the provided 510(k) summary.
Conclusion:
The provided document describes a medical device (bone plates) that is not an AI/ML-based diagnostic or prognostic device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., sensitivity, specificity, AUC, human reader improvement, ground truth methodology) are not applicable or detailed in this submission. The "study" mentioned is a "pre-clinical evaluation" to support substantial equivalence, likely involving mechanical or material testing, not the evaluation of an algorithm's diagnostic accuracy.
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510(k) Summary of Safety and Effectiveness
PERI-LOC Ankle Fusion Bone Plates. VLP 2.7mm Extra Large Percutaneous Calcaneus Plate and Device Specific Instrument
4 2012
Submitted By:
Date:
Smith & Nephew, Inc. Orthopaedics 1450 Brooks Road Memphis, TN 38116
March 2, 2012
David Henley, Regulatory Affairs Project Manager Tel: (901) 399-6487 Fax: (901) 566-7079
PERI-LOC Ankle Fusion Bone Plates, VLP 2.7mm Extra Large Percutaneous Calcaneus Plate and Device Specific Instrument
Common Name:
Contact Person:
Proprietary Name:
Classification Name and Reference:
Device Product Code and Panel Code:
Bone Plates
21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories - Class II
HRS / Orthopedics / 87
Device Description:
The subject devices are comprised of implantable, locking bone plates and a device specific instrument. All described implants are manufactured from implant grade stainless steel material. The subject implant devices are available in the following sizes:
| Device Type | Available Length |
|---|---|
| PERI-LOC 3.5mm Ankle Fusion Plates, Anterior Primary,LH/RH with Compression Slot, 3H | 67mm |
| PERI-LOC 3.5mm Ankle Fusion Plates, Anterior Primary,LH/RH with Compression Slot, 5H | 92mm |
| PERI-LOC 3.5mm Hindfoot Ankle Fusion Utility Plates,LH/RH with Compression Slot, 5H | 104mm |
| VLP 2.7mm Percutaneous Calcaneus Plates, Extra Large, LH/RH | 68mm |
A new device specific instrument is also described in this Special 510(k) premarket notification in select sections and exhibits.
Intended Use:
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic
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bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
Technological Characteristics:
The PERI-LOC Ankle Fusion Plates and VLP Extra Large Percutaneous Calcaneus Plate are very similar to legally marketed devices cleared under K110670. When compared to the predicates from K110670, the proposed devices share identical indications for use and intended use, are manufactured from identical materials, and incorporate identical or very similar technological design characteristics. The device specific instrument described in this premarket notification is also very similar to the predicate device specific instruments cleared under K110670.
Substantial Equivalence Information:
When compared to the predicate implant and device specific instrument devices cleared under the premarket notification listed below, substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.
- · VLP FOOT Plating System and PERI-LOC Ankle Fusion Plating System Locking Bone Plates and Screws and Device Specific Instruments - K110670
To further support a determination of substantial equivalence, a pre-clinical evaluation was conducted on the PERI-LOC Ankle Fusion Plates described in this premarket notification. Results were compared against previously cleared PERI-LOC Ankle Fusion Plate predicate devices described above and cleared under K110670.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, TN 38116
APR - 4 2012
Re: K120667
Trade/Device Name: PERI-LOC Ankle Fusion Bone Plates, VLP 2.7mm
Extra Large Percutaneous Calcaneus Plate and Device Specific Instrument
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: HRS Dated: March 2, 2012 Received: March 5, 2012
Dear Mr. Henley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. David Henley
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
~Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
PERI-LOC Ankle Fusion Plates and VLP Extra Large Percutaneous Calcaneus Plate
Indications for Use:
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in
the Smith & 10 mm (10 millional odsleenent (18,21 years) subpopular The Smith & Nepliew I LINECOO Allike Frasitional adolescent (18-21 years) subpopulations
adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations adolescent (12-10 years) and transitional anie boom. The PER-LOC Ankle Fusion
and adults, as well as patients with osteopend from the distal and adults, as well as patients with occopyine befores, including the distal tibia, talus and calcaneus.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18)
The Smith & Nepher (110-11-11) Start and outpanylations and edults, as well ine Smith & Nephew VEF | OO f 18-21 years) subpopulations and adults, as well years) and transitional adoloosins (10 ECP FOOT Plating System is indicated for as patients with Osteopenie bone. THE views of small bones, including those in the forefoot, midfoot and hindfoot.
PERI-LOC Ankle Fusion Bone Plates and the VLP Extra Large Percutaneous Calcaneus Plate are for single use only.
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122667
§ 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.