(24 days)
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
- Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
- Primary arthritis (e.g. degenerative disease)
- Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
Provided sufficient bone stock is present.
Note - In the United States, this device is intended for cemented use only.
Note - Outside the United States, this device is intended for cemented or cementless use.
The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talar dome and an insert. The tibial tray and talar dome are secured to patient anatomy. The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint. Each of the three components is available in a variety of sizes and design configurations intended for both primary and revision surgery applications. The Cadence System also consists of various instrumentation to allow for appropriate implantation of the Cadence Prosthesis.
The scope of the Cadence System is being extended to include additional options for the talar domes. The new talar dome option features a flat cut design in comparison to the currently commercialized talar dome chamfer cut design. New instrumentation will also be introduced to aid in the implantation of the new flat cut talar dome design.
The provided document is a 510(k) premarket notification for a medical device called the "Cadence Total Ankle System". This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate.
Crucially, this document describes a comparative study for substantial equivalence, not a study proving an AI/software device meets specific performance acceptance criteria for a novel functionality. Therefore, the information requested in the prompt, such as acceptance criteria for reported device performance (e.g., accuracy, sensitivity, specificity for an algorithm), sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this type of medical device submission.
The document states:
- "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device." (Page 5)
- The substantial equivalence conclusion is based on:
- The modified and predicate device having exactly the same intended use.
- Both devices operating using the same fundamental scientific technology.
- Both devices sharing the same functional and technological characteristics via the same operational principles.
- No new issues or concerns related to safety or effectiveness raised by the modified device.
Instead of clinical performance data, the submission relies on nonclinical performance data to show that the modified device (Cadence Total Ankle System) is substantially equivalent to the unmodified device (Integra Total Ankle Replacement System, K151459).
Here's an analysis of the provided information, addressing the prompt's points where applicable, and clarifying why others are not relevant given the document's nature:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Nonclinical Equivalence) | Reported Device Performance (Nonclinical Testing) |
|---|---|
| Demonstrate substantial equivalence to the unmodified device in: | The modified device was subjected to and passed verification testing/analyses in comparison to the unmodified device for: |
| - Constraint | (Implicitly met, as stated in the conclusion of substantial equivalence) |
| - Bone Stability | (Implicitly met) |
| - Range of Motion | (Implicitly met) |
| - Fatigue Strength | (Implicitly met) |
| - Contact Area and Pressure Distribution | (Implicitly met) |
| - Wear | (Implicitly met) |
Explanation: The "acceptance criteria" here are not performance metrics like accuracy or sensitivity for an algorithm, but rather engineering and biomechanical equivalence to the predicate device. The document states these tests were performed and imply they met the necessary thresholds to demonstrate substantial equivalence. Specific quantitative results are not provided in this summary.
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 document describes non-clinical (mechanical/materials) testing for a physical implant, not a study involving patient data or test sets in the context of an algorithm. The "data" refers to engineering test results, not clinical patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective studies are not relevant.
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. No human experts (like radiologists) were involved in establishing "ground truth" for the non-clinical tests described. The "ground truth" for these tests would be established by engineering standards and measurement techniques.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no expert review or human interpretation of a "test set" (like medical images) was performed, no adjudication method was needed.
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/software device, so MRMC studies and human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's testing is based on engineering and biomechanical standards and measurements. For example, force applied, displacement, material properties, and wear rates would be measured against established benchmarks and the performance of the predicate device.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set."
Summary of the Study Proving the Device Meets Substantial Equivalence Criteria:
The "study" in this context is a series of nonclinical verification tests and analyses designed to demonstrate that the modified Cadence Total Ankle System is as safe and effective as its predicate device (Integra Total Ankle Replacement System, K151459). These tests focus on the physical and mechanical properties of the implant.
-
Nonclinical Performance Data: The device was subjected to testing and/or analyses related to:
- Constraint
- Bone Stability
- Range of Motion
- Fatigue Strength
- Contact Area and Pressure Distribution
- Wear
-
Conclusion: The submission concludes that "substantial equivalence of the modified device and predicate device is based on" the factors listed above, and that "After evaluation of the risks and performance data, the modified device does not raise any new issues or concerns related to safety or effectiveness." This implies that the device met the implicit acceptance criteria for these nonclinical tests by performing comparably to the predicate or within acceptable engineering limits.
In essence, this document is a regulatory submission for a physical medical device, not an AI/software device, and thus the prompt's questions related to AI/software performance validation are not answered because they are not relevant to this type of submission.
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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 29, 2020
Integra Lifesciences Corporation Ascension Orthopedics, Inc. Cassidy Lemkau Regulatory Affairs Specialist 11101 Metric Blvd Austin, Texas 78758
Re: K201507
Trade/Device Name: Cadence Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: June 4, 2020 Received: June 5, 2020
Dear Cassidy Lemkau:
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.
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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); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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) K201507
Device Name Cadence Total Ankle System
Indications for Use (Describe)
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
| - Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis) |
|---|
| - Primary arthritis (e.g. degenerative disease) |
| - Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved) |
Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
Provided sufficient bone stock is present.
Note - In the United States, this device is intended for cemented use only.
Note - Outside the United States, this device is intended for cemented or cementless use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | 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 Integra logo. The word "INTEGRA" is written in gray, and below it, the phrase "LIMIT UNCERTAINTY" is written in green. To the right of the word "INTEGRA" are four green squares of varying sizes.
510(k) Summary
| Sponsor | Integra Lifesciences Corp.Ascension Orthopedics, Inc.11101 Metric Blvd.Austin, TX 78758 |
|---|---|
| EstablishmentNumber | 3014207283 |
| Point of Contact | Cassidy LemkauRegulatory Affairs Specialist11101 Metric Blvd.Austin, TX 78758402-990-4239 |
| Date | 06/06/2020 |
| Trade Name | Cadence Total Ankle System |
| Common Name | Ankle Implant |
| ClassificationPanel | Orthopedic |
| Classification | Class II |
| Regulation No. | 21 CFR 888.3110 |
| Regulation Name | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| Product Code | HSN |
| Predicate Device | K151459Integra Total Ankle Replacement System |
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| Reference Device | K182878Integra Salto Total Ankle System |
|---|---|
| DeviceDescription | The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talardome and an insert. The tibial tray and talar dome are secured to patient anatomy.The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as abearing along the talar dome, enabling flexion and extension movement at thereplaced joint. Each of the three components is available in a variety of sizes anddesign configurations intended for both primary and revision surgeryapplications. The Cadence System also consists of various instrumentation toallow for appropriate implantation of the Cadence Prosthesis. |
| The scope of the Cadence System is being extended to include additional optionsfor the talar domes. The new talar dome option features a flat cut design incomparison to the currently commercialized talar dome chamfer cut design. Newinstrumentation will also be introduced to aid in the implantation of the new flatcut talar dome design. | |
| Intended Use/Indications for Use | The Cadence Total Ankle System is designed to treat ankle arthritis throughreplacement of the ankle joint with a prosthesis, thereby reducing pain, restoringalignment, and allowing for movement at the replaced joint.The Cadence Total Ankle System is indicated for use to treat:- Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)- Primary arthritis (e.g. degenerative disease)- Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3of the talus is preserved)Cadence Total Ankle System is also indicated for revision surgeries followingfailed total ankle replacement and non-union/mal-union of ankle arthrodesis.Provided sufficient bone stock is present. |
| Note - In the United States, this device is intended for cemented use only.Note - Outside the United States, this device is intended for cemented orcementless use. |
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| NonclinicalPerformance Data | The modified device was subjected to the following verification testing and/oranalyses to establish substantial equivalence in comparison to the unmodifieddevice.1. Constraint2. Bone Stability3. Range of Motion4. Fatigue Strength5. Contact Area and Pressure Distribution6. Wear |
|---|---|
| ClinicalPerformance Data | Clinical performance data is not required to demonstrate substantial equivalenceto the predicate device. |
| SubstantialEquivalenceConclusion | Substantial equivalence of the modified device and predicate device is based onthe following:• The modified and predicate device have exactly the same intended use.• Both devices operate using the same fundamental scientific technology.• Both devices share the same functional and technological characteristicsvia the same operational principles.After evaluation of the risks and performance data, the modified device does notraise any new issues or concerns related to safety or effectiveness. |
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.