(60 days)
The ORTHOLOC™ 2 Lapidus with Rotation System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
The ORTHOLOC™ 2 Lapidus with Rotation System is designed to facilitate arthrodesis of the first metatarsal-cuneiform joint, or Lapidus fusion. The system achieves its intended effect through the use of plates of various designs and both locking and non-locking screw configurations.
The provided text is a 510(k) summary for the ORTHOLOC™ 2 Lapidus with Rotation System, a bone fixation device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets acceptance criteria defined by performance metrics like sensitivity or specificity.
Therefore, this document does not contain the requested information regarding acceptance criteria, reported device performance (in terms of clinical metrics), sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML device.
Instead, the submission relies on non-clinical evidence to demonstrate substantial equivalence to a legally marketed predicate device.
Here's what can be extracted from the document regarding the "study" that proves the device meets acceptance criteria (in the context of a 510(k) for a traditional medical device):
Acceptance Criteria and Device Performance (in the context of a traditional device):
The "acceptance criteria" here are implicitly related to the performance of the predicate device and established standards for metallic bone fixation appliances. The device is deemed to meet these criteria if its performance is comparable and safe.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength as per ASTM F382 (Static Four-Point Bend) | Testing conducted; results indicate performance comparable to predicate. |
| Absence of pyrogens (Pyrogenicity Analysis per ANSI/AAMI ST72:2011) | Testing conducted; results indicate the device is non-pyrogenic. |
| Material composition (Titanium Alloy) | Identical materials as the legally marketed predicate device. |
| Sterilization methods | Identical sterilization methods as the legally marketed predicate device. |
Detailed breakdown of your requested information based on the provided text:
-
A table of acceptance criteria and the reported device performance
See the table above. The "acceptance criteria" for a 510(k) are typically that the new device performs at least as well as the predicate and meets relevant safety standards and performance specifications from recognized standards. Specific numerical performance metrics (like sensitivity/specificity for AI) are not provided for this type of device. -
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 traditional medical device (bone plate) and the "testing" refers to benchtop engineering tests, not a clinical study with patient data in the way an AI/ML device would. No patient data or clinical test sets are mentioned. -
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. Ground truth for clinical data is not relevant here as no clinical data studies are presented. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical data test set. -
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. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be the established physical and chemical properties of the materials and the performance standards defined by ASTM and ANSI/AAMI. -
The sample size for the training set
Not applicable. No training set for an AI/ML algorithm is mentioned. -
How the ground truth for the training set was established
Not applicable. No training set for an AI/ML algorithm.
In summary, the provided document is a 510(k) submission for a non-AI bone fixation device. The "studies" conducted are non-clinical engineering tests (static four-point bend, pyrogenicity analysis) to demonstrate its physical performance and safety characteristics are substantially equivalent to a predicate device and meet established standards. It does not contain the type of AI/ML-specific performance metrics or study details you requested.
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Image /page/0/Picture/0 description: The image shows the date May 14, 2019. The month is spelled out, followed by the day and year. The text is in a clear, sans-serif font and is easy to read. The date is likely extracted from a document or image.
FDA U.S. FOOD & DRUG
ADMINISTRATION
Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K190670
Trade/Device Name: ORTHOLOC 2 Lapidus with Rotation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: March 11, 2019 Received: March 15, 2019
Dear Alayne Melancon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Assistant Director THT6C2: Fracture Fixation and Stereotaxic Devices Team DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190670
Device Name ORTHOLOC™ 2 Lapidus with Rotation System
Indications for Use (Describe)
The ORTHOLOC™ 2 Lapidus with Rotation System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side. To the right of the trapezoids is the word "WRIGHT" in red, with a small trademark symbol next to it. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
1023 Cherry Road Memphis, TN 38117 wright.com
510(k) SUMMARY
In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC™ 2 Lapidus with Rotation System.
(a)(1) MANUFACTURER IDENTIFICATION
| Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|
| Date: | May 13, 2019 |
| Contact Person: | Alayne MelanconRegulatory Affairs SpecialistOffice: (901)290-5986Fax: (901)867-4190 |
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | ORTHOLOC™ 2 Lapidus with Rotation System |
|---|---|
| Common Name: | Bone Plate |
| Classification Name & Reference: | Single/multiple component metallic bone fixationappliances and accessories - 21 CFR 888.3030 – Class II |
| Device Product Code & Panel: | HRS - Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
ORTHOLOC™ 3Di Hallux System K120359
(a)(4) DEVICE DESCRIPTON
The ORTHOLOC™ 2 Lapidus with Rotation System is designed to facilitate arthrodesis of the first metatarsal-cuneiform joint, or Lapidus fusion. The system achieves its intended effect through the use of plates of various designs and both locking and non-locking screw configurations.
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(a)(5) INTENDED USE
The ORTHOLOC™ 2 Lapidus with Rotation System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The ORTHOLOC™ 2 Lapidus with Rotation System is manufactured from identical materials (i.e. Titanium Alloy) and has identical sterilization methods as the legally marketed predicate device. The subject plates of the system are available in both large and standard, left and right orientations, and are designed with plantar steps to maintain an anatomical fit across the joint for varying amounts of correction.
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The following evaluations were conducted to support the safety and efficacy of the ORTHOLOC™ 2 Lapidus with Rotation System
- Static Four-Point Bend Testing per ASTM F382 l
- -Pyrogencity Analysis per ANSI/AAMI ST72:2011
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.
§ 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.