eCarbon IBDs by Back 2 Basics Direct, LLC

The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

Device Description

The eCarbon IBDs are a collection of interbody devices. The cervical implants (eCarbon-C) have basic keystone shape in a columnar form while the lumbar devices (eCarbon-P) are essentially rectangular. All have a central cavity for bone graft and are offered in a variety of height, length, width and lordotic angulation combinations are available to accommodate the anatomic requirements of individual patients.

AI/ML Overview

The provided text is a 510(k) Summary for the eCarbon IBDs, which are intervertebral body fusion devices. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance reporting as one might find for novel AI/imaging devices.

Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an algorithm's performance.

Instead, the "Performance Data" section describes mechanical testing performed to demonstrate that the eCarbon IBDs are mechanically equivalent to their predicate devices.

Here's the information that can be extracted related to performance and testing:

1. Table of acceptance criteria and reported device performance:

The document does not specify quantitative acceptance criteria in terms of a pass/fail threshold. Instead, it states that the test results "demonstrated equivalent mechanical performance... compared to the cited predicate devices under the same test conditions." This implies that the performance of the eCarbon IBDs was expected to be comparable to or better than the predicate devices in the specific tests.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance	Demonstrated equivalent mechanical performance compared to cited predicate devices under the same test conditions.
	Worst-case eCarbon cervical implant: Tested for static and dynamic compression, and static and dynamic torsion according to ASTM F2077.
	Worst-case eCarbon lumbar implant: Tested for static and dynamic compression according to ASTM F2077.
	Both worst-case eCarbon implants: Evaluated for subsidence according to ASTM F2267 and expulsion testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for each test, but refers to "worst case eCarbon cervical implant" and "worst case eCarbon lumbar implant," implying a limited number of samples representing the most challenging configurations. These would be physical samples for mechanical testing, not data samples in the context of an AI study.
Data Provenance: Not applicable in the context of clinical data provenance (e.g., country, retrospective/prospective). This refers to laboratory mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. "Ground truth" in this context would refer to established mechanical testing standards (ASTM F2077, ASTM F2267) which define how the performance is measured, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. Mechanical tests follow predefined protocols, and the results are quantitative measurements, not subjective interpretations requiring 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:

Not applicable. This is a medical device (intervertebral body fusion devices) for which mechanical performance, not AI-assisted image interpretation, is being evaluated.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is not an algorithm, but a physical implant.

7. The type of ground truth used:

The "ground truth" for mechanical testing is established by recognized industry standards (ASTM F2077, ASTM F2267) and the physical properties and behavior of the identical predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI device.

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" as this is not an AI device.

Summary

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September 26, 2019

Back 2 Basics Direct, LLC % Karen Warden, PhD President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026

Re: K191537

Trade/Device Name: eCarbon IBDs Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 2, 2019 Received: September 4, 2019

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 Ronald P. Jean, PhD Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191537

Device Name eCarbon IBDs

Indications for Use (Describe)

The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

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

Date:	7 June 2019
Sponsor:	Back 2 Basics Direct, LLC6701 Rockside Road, Suite 200Independence, OH 44131Office: 216.447.5205Fax: 216.447.6071
Sponsor Contact:	Scot Miller, DO, Principal
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Proposed Trade Name:	eCarbon IBDs (eCarbon-C and eCarbon-P)
Common Name:	Cervical and lumbar interbody fusion devices
Device Classification:	Class II
Regulation Names,Regulation Numbers,Product Codes:	Intervertebral fusion device with bone graft, 888.3080, cervical, ODPIntervertebral fusion device with bone graft, 888.3080, lumbar, MAX
Device Description:	The eCarbon IBDs are a collection of interbody devices. The cervicalimplants (eCarbon-C) have basic keystone shape in a columnar form whilethe lumbar devices (eCarbon-P) are essentially rectangular. All have acentral cavity for bone graft and are offered in a variety of height, length,width and lordotic angulation combinations are available to accommodatethe anatomic requirements of individual patients.
Indications for Use:	The eCarbon-C is intended for anterior intervertebral body fusion inskeletally mature patients who have had at least six weeks of non-operativetreatment. The eCarbon-C is indicated to treat cervical disc degenerationand/or cervical spinal instability, as confirmed by imaging studies(radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/orpain at one level or two contiguous levels from C2 - T1. The eCarbon-C is tobe used with supplemental fixation. The implants are designed for use withautogenous and/or allogeneic bone graft comprised of cancellous and/orcorticocancellous bone to facilitate fusion.The eCarbon-P is intended for spinal fusion procedures in skeletally maturepatients with degenerative disc disease (defined as discogenic back painwith degeneration of the disc confirmed by history and radiographic studies)at one or two contiguous spinal levels from L2-S1. These patients shouldhave had six months of nonoperative treatment. These patients may havehad a previous non-fusion spinal surgery and/or may have up to Grade 1spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally,the eCarbon-P can be used as an adjunct to fusion in patients diagnosedwith degenerative scoliosis. The eCarbon-P is to be used with autograftand/or allograft comprised of cancellous and/or corticocancellous bone graftand with supplemental fixation indicated for lumbar spinal fusionprocedures.
Materials:	The eCarbon IBDs are manufactured from PEEK-OPTIMA Ultra Reinforcedpolymer (PEEK-OPTIMA per ASTM F2026 and carbon fibers). Integralmarkers are manufactured from gold wire (per ASTM B562).
Primary Predicate:	Cascadia Interbody System (K2M Inc. - K160125)
Additional Predicates:	KIMBA® and KIMBA® Mini (SIGNUS Medizintechnik GmbH – K111792),MC+ (LDR Holding – K043479/K091088)
Performance Data:	Mechanical testing of the worst case eCarbon cervical implant includedstatic and dynamic compression and static and dynamic torsion accordingto ASTM F2077. Mechanical testing of the worst case eCarbon lumbarimplant included static and dynamic compression according to ASTMF2077. In addition, both worst case eCarbon implants were evaluated forsubsidence according to ASTM F2267 and expulsion testing.The test results demonstrated equivalent mechanical performance of theeCarbon cervical and lumbar IBDs compared to the cited predicatedevices under the same test conditions.
TechnologicalCharacteristics:	The eCarbon IBDs possess the same technological characteristics as oneor more of the predicate devices. These include:• intended use (as described above)• basic design (structural column),• material (reinforced polymer) and• sizes (dimensions are comparable to those offered by the predicatesystems)Therefore the fundamental scientific technology of the eCarbon IBDs is thesame as previously cleared devices.
Conclusion:	The eCarbon IBDs possess the same intended use and technologicalcharacteristics as the predicate devices. Therefore the eCarbon IBDs aresubstantially equivalent for their intended use.

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Regulation Number and Section

§ 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.