(32 days)
The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.
The provided text is a 510(k) summary for the Axis Charcot Fixation System, a medical device. It does not include information about AI/ML device performance, acceptance criteria, or studies involving human readers, as it describes a bone fixation system.
Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluation.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner typical for AI/ML performance. Instead, it refers to "engineering analyses evaluating mechanical strength" and "pullout strength". The performance determined was "substantially equivalent to the predicate devices for the intended use."
| Acceptance Criteria (Inferred from testing type) | Reported Device Performance |
|---|---|
| Mechanical strength of the smallest beam diameter (4.5mm) is substantially equivalent to predicate. | Demonstrated substantial equivalence to predicate devices. |
| Pullout strength of the shortest, smallest beam diameter is substantially equivalent to predicate. | Demonstrated substantial equivalence to predicate devices. |
| The largest beam diameter (8.5mm) is no worst case than the predicates. | No additional safety and effectiveness concerns presented. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The testing described is mechanical, not involving patient data or a "test set" in the context of an AI/ML device.
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)
This information is not applicable and not provided. The "ground truth" for this device would be established through engineering standards and physical measurements, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Mechanical testing does not involve adjudication.
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
No such study was performed or is relevant to this device. This device is a physical bone fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering standards and physical measurements of mechanical properties (strength, pullout force).
8. The sample size for the training set
This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.
In summary, the provided document describes a 510(k) submission for a physical medical device (bone fixation system) and does not contain information related to AI/Machine Learning device performance or ground truth establishment in the context of diagnostic or interventional AI.
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May 28, 2021
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Medical, LLC. Mary Hoffman Manager, Quality Assurance and Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K211261
Trade/Device Name: Axis Charcot Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: April 23, 2021 Received: April 26, 2021
Dear Mary Hoffman:
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
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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K211261
Device Name Axis Charcot Fixation System
Indications for Use (Describe)
The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
| 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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Special 510(k) Summary of Safety and Effectiveness:
| Submitter | Extremity Medical, LLC300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Mary Hoffman, MSManager, Quality Assurance and Regulatory AffairsPhone: (973) 588-8980Email: mhoffman@extremitymedical.com |
| Date Prepared | May 27, 2021 |
| Trade Name | Axis Charcot Fixation System |
| ClassificationName andNumber | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener (Primary)21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories |
| Product Code | HWC (screw, fixation, bone) (Primary)HTN (washer, bolt, nut) |
| PrimaryPredicates | K171018 - Axis Charcot Fixation System/ 4.5 to 8.5 Screw System |
| AdditionalPredicates | K190586 – Paragon 28 Monster Screw SystemK193366 – Stryker T2 ICF SystemK140741 - Wright Medical Salvation Beams and Bolts System |
| DeviceDescription | The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloyfixation beams and accessories used for midfoot reconstruction. The modified device addsadditional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previouslycleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizesoffer the surgeon options for placement based on patient anatomy. |
| Indications foruse | The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated forreconstruction procedures, non-unions and fusions of bones in the foot and ankle includingthe metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examplesinclude: medial and lateral column fusion resulting from neuropathic osteoarthropathy(Charcot). |
| Statement ofTechnologicalComparison | The Axis Charcot Fixation System consists of bone screws used for fixation in the foot forarthrodesis procedures. The sizes of screws offered in the Axis System (4.5 to 8.5mm) areequivalent to the predicate devices in terms of design and material mechanical properties,and in indications for use. |
| Non-clinicalTesting | Engineering analyses evaluating mechanical strength of the smallest beam diameter (4.5mm) and pullout strength of the shortest, smallest beam diameter demonstrated that the modified device is substantially equivalent to the predicate devices for the intended use.Additionally, the largest beam diameter (8.5mm) is no worst case than the predicates therefore no additional safety and effectiveness concerns are presented for the subject device in relation to the implant's size for the patient anatomy. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Axis Charcot Fixation System is substantially equivalent to its predicate device. This conclusion is based upon indications for use, principles of operation, design, engineering and mechanical test evaluation. |
Axis Charcot Fixation System
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§ 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.