(29 days)
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
CarboClear® Lumbar Cage System is composed of implants of various sizes and lordotic angles, and instruments.
The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.
The provided text is a 510(k) summary for the CarboClear® Lumbar Cage System, a medical device for intervertebral body fusion. It describes the product, its intended use, and claims substantial equivalence to predicate devices, but it does NOT contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study for an AI/ML device would.
Therefore, I cannot provide the requested table or specific points related to acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document. The 510(k) process for this type of device (an intervertebral body fusion device) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than novel clinical performance studies with acceptance criteria in the sense typically applied to diagnostic AI.
Here's what I can extract based on the provided information, but it won't fulfill all your requested points:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate mechanical performance. | "Performance characteristics included finite element analysis with supportive testing according to ASTM F2077 and expulsion test. The results of the analysis/tests are comparable to those of the predicate devices, demonstrating substantially equivalent mechanical performance of the subject device." |
| Intended Use/Indications for Use matching predicates. | The intended use and indications for use for the CarboClear® Lumbar Cage System are described and implicitly accepted as equivalent to predicate devices to demonstrate substantial equivalence. (e.g., "intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD)... at one or two contiguous levels from L2 to S1... with supplemental fixation cleared for use in the lumbosacral spine.") |
| Material, design, dimensions, technological characteristics, and principles of operation are substantially equivalent to predicates. | "The intended use, design, material, dimensions, technological characteristics, and principles of operation of the subject CarboClear® Lumbar Cage System are substantially equivalent to those of the predicate devices." |
Explanation of Limitations:
- No explicit "acceptance criteria" for clinical performance: This document is a 510(k) summary for a physical implant, not an AI/ML diagnostic. The "acceptance criteria" here are geared towards demonstrating safety and effectiveness based on equivalence to existing devices, primarily through mechanical testing and comparison of features, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI clearances.
- No "study" in the sense of AI/ML clinical validation: The "study" mentioned is primarily focused on mechanical performance (finite element analysis, ASTM F2077 testing, expulsion test) to ensure the device is physically robust and performs similarly to predicate devices. There is no mention of a human-in-the-loop study, a standalone algorithm performance study, or a study involving human readers or expert radiologists to establish ground truth for clinical diagnostic performance.
Regarding your specific points where information is not available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable in this context. The "test set" here refers to mechanical testing, not a clinical data set for performance evaluation in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical performance, the ground truth would be the established engineering standards (e.g., ASTM F2077) and physical measurements. For the overall device, the ground truth for safety and effectiveness is established by comparison to legally marketed predicate devices that have a history of safe and effective use.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (not an AI/ML device).
In summary, the provided document details the regulatory clearance of a physical medical implant based on substantial equivalence to predicate devices, supported by mechanical testing. It does not provide the type of performance evaluation details typically associated with AI/ML diagnostic software.
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January 15, 2020
CarboFix Orthpedics Ltd. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'Hoshlim Street Herzeliya, 4672411 Israel
Re: K203683
Trade/Device Name: CarboClear® Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 14, 2020 Received: December 17, 2020
Dear Hila Wachsler-Avrahami:
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 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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Indications for Use
510(k) Number (if known)
Device Name
CarboClear® Lumbar Cage System
Indications for Use (Describe)
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine .
Patients should have at least six months of non-operative treatment prior to surgery.
| 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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510(k) Summary
CarboFix Orthopedics Ltd. CarboClear® Lumbar Cage System
Applicant Name
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Hila Wachsler-Avrahami CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
December 14, 2020
Trade/Proprietary Name
CarboClear® Lumbar Cage System
Common Name
Intervertebral Body Fusion Device
Regulation Number and Device Class
21 CFR §888.3080; Class II
Product Code and Review Panel
MAX; Orthopedic
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Predicate Devices
Primary Predicate Device:
CarboClear® Lumbar Cage System (CarboFix Orthopedics Ltd.; K193378)
Additional Predicate Devices:
- " CONCORDE® Bullet Lumbar Interbody System (DePuy Spine, Inc .; K151773)
- FORZA® PTC Spacer System (Orthofix Inc.; K152475)
- icotec Interbody Cage System (icotec ag: K172480)
- eCarbon-P IBD (Back 2 Basics Direct, LLC; K191537)
- Tritanium® PL Posterior Lumbar Cage (Striker; K152304)
Intended Use/Indications for Use
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
System Description
CarboClear® Lumbar Cage System is composed of implants of various sizes and lordotic angles, and instruments.
The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.
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Purpose of Submission
The purpose of this Special 510(k) Premarket Notification is to add lordotic lumbar cages to the CarboClear® Lumbar Cage System.
Performance Data and Substantial Equivalence
The intended use, design, material, dimensions, technological characteristics, and principles of operation of the subject CarboClear® Lumbar Cage System are substantially equivalent to those of the predicate devices.
Performance characteristics included finite element analysis with supportive testing according to ASTM F2077 and expulsion test. The results of the analysis/tests are comparable to those of the predicate devices, demonstrating substantially equivalent mechanical performance of the subject device.
Conclusion
Based on the information provided in this Premarket Notification, the subject CarboClear® Lumbar Cage System is substantially equivalent to its predicate devices.
§ 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.