(20 days)
The NEXXT MATRIXX® Stand Alone Cervical-TL System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical-TL System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical-TL System is intended to be used with the bone screw fixation provided and requires no additional fixation.
NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical-TL System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7 µm). The intervening geometric lattices have 300-700um pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with a turn lock mechanism which secures the screw to the spacer component.
The provided text describes a 510(k) premarket notification for the NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System, a Class II intervertebral body fusion device. The submission focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and performance metrics for an AI/ML device.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving device performance, as the document does not contain this information. The document pertains to a medical device clearance for an implant, not an AI/ML diagnostic or assistive technology.
Here's a breakdown of why the requested information is not available in the provided document:
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A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics in terms of sensitivity, specificity, accuracy, or other related metrics. It states, "The modified Stand Alone Cervical-TL device components were evaluated via dimensional analyses. The results demonstrated the performance of the modified Stand Alone Cervical-TL device is substantially equivalent to the predicate. In addition, the screw pushout properties for the modified Stand Alone Cervical-TL construct were evaluated." This refers to mechanical and physical properties of the implant, not diagnostic performance.
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Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/ML system tested on a dataset.
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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" in the context of an AI/ML device (e.g., expert-labeled images) is not relevant for this physical device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 type of study is relevant for AI-assisted diagnostic tools, not for an intervertebral body fusion device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter for a spinal implant, which confirms its substantial equivalence to a predicate device based on mechanical and material characteristics. It does not address AI/ML system performance or related study details.
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March 23, 2020
Nexxt Spine, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026
Re: K200543
Trade/Device Name: NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: March 2, 2020 Received: March 3, 2020
Dear Dr. Warden:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 mediation-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,
for Brent Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System
Indications for Use (Describe)
The NEXXT MATRIXX® Stand Alone Cervical-TL System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical-TL System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical-TL System is intended to be used with the bone screw fixation provided and requires no additional fixation.
| 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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Section 7 – 510(k) Summary
| Date: | 2 March 2020 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc.PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System |
| Common Name: | Cervical spacer with integrated fixation |
| Device Classification: | Class II |
| Regulation Name,Regulation Number,Product Code: | Intervertebral fusion device with integrated fixation, cervical, 888.3080, OVE |
| Submission Purpose: | The subject 510(k) adds an line of implants having an alternative screwretention feature to the NEXXT MATRIXX® Stand Alone Cervical System. |
| Device Description: | NEXXT MATRIXX® is a collection of additively manufactured implants. TheStand Alone Cervical-TL System includes additively manufactured spacerand traditionally machined fixation screw implants. The spacer and screwcomponents are available in an assortment of dimensional combinations toaccommodate the individual anatomic and clinical circumstances of eachpatient.The basic shape of the spacer is a structural column to provide surgicalstabilization of the spine. Each device comprises an external structural |
| frame having a roughened surface (~7 µm). The intervening geometriclattices have 300-700um pores. The inferior/superior aspects of the spacerincorporates a vertical cavity which can be packed with bone graft material.Each interbody is preassembled with a turn lock mechanism which securesthe screw to the spacer component. | |
| Indications for Use: | The NEXXT MATRIXX® Stand Alone Cervical-TL System is a stand-aloneanterior cervical interbody fusion system intended for use as an adjunct tofusion at one or two contiguous levels (C2-T1) in skeletally mature patientsfor the treatment of degenerative disc disease (defined as discogenic neckpain with degeneration of the disc confirmed by history and radiographicstudies). These patients should have received at least six weeks ofnonoperative treatment prior to treatment with the device. The NEXXTMATRIXX® Stand Alone Cervical-TL System is to be used with autograftbone graft and/or allogeneic bone graft composed of cancellous and/orcorticocancellous bone and implanted via an open, anterior approach. TheNEXXT MATRIXX® Stand Alone Cervical-TL System is intended to be usedwith the bone screw fixation provided and requires no additional fixation |
| Materials: | NEXXT MATRIXX® Stand Alone Cervical System spacers are manufacturedfrom Ti-6Al-4V ELI titanium alloy per ASTM F3001. The fixation screws andturn lock components are manufactured from Ti-6AI-4V ELI titanium alloyper ASTM F136. |
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| Primary Predicate: | NEXXT MATRIXX® Stand Alone Cervical System (Nexxt Spine, LLC – K190546) |
|---|---|
| Performance Data: | The modified Stand Alone Cervical-TL device components were evaluated via dimensional analyses. The results demonstrated the performance of the modified Stand Alone Cervical-TL device is substantially equivalent to the predicate. In addition, the screw pushout properties for the modified Stand Alone Cervical-TL construct were evaluated. |
| Technological Characteristics: | The modified Stand Alone Cervical-TL device possesses the same technological characteristics as one or more of the predicate devices. These include: performance (as described above), basic design (additively manufactured structure and integrated fixation), material (titanium alloy) and size (dimensions are comparable to those offered by the cleared devices). Therefore the fundamental scientific technology of the modified Stand Alone Cervical-TL device is the same as previously cleared devices. |
| Conclusion: | The modified Stand Alone Cervical-TL System possesses the same intended use and technological characteristics as the predicate devices. Therefore the modified Stand Alone Cervical-TL System is substantially equivalent for its intended use. |
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.