(167 days)
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by pairent history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
The Camber Spine Technologies ENZA™-A Titanium ALIF is an Interbody Fusion Device that has a hollow chamber to permit packing with autogenous graft material to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior and inferior anchoring plates. These implants may be implanted via a laparoscopic or an open anterior approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The provided text describes a 510(k) premarket notification for a medical device called the ENZA™-A Titanium ALIF, an intervertebral body fusion device. The focus of this document is to demonstrate "substantial equivalence" to predicate devices, rather than providing a performance study to prove the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy.
Therefore, the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria (especially points 2-9 which are highly relevant to AI/ML device testing) cannot be fully answered as presented in this document. This document details the mechanical testing performed, but not clinical performance or diagnostic accuracy.
However, I can extract information related to the mechanical performance testing that was done to support substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document states: "Testing performed indicate that the ENZA™-A Titanium ALIF is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met."
While the specific numerical acceptance criteria and reported device performance (e.g., actual force values or displacement) are not provided in this summary, the key statement is that the acceptance criteria defined by predicate device performance were met. This implies that the new device's performance in mechanical testing was comparable to or better than the predicate devices against the standards ASTM F2077-14 and F2267-04.
| Acceptance Criterion (Type of Testing) | Reported Device Performance |
|---|---|
| Static Compression (per ASTM F2077-14) | Met predicate device performance standards |
| Static Compression-Shear (per ASTM F2077-14) | Met predicate device performance standards |
| Dynamic Compression (per ASTM F2077-14) | Met predicate device performance standards |
| Dynamic Compression-Shear (per ASTM F2077-14) | Met predicate device performance standards |
| Expulsion (per ASTM F2267-04) | Met predicate device performance standards |
| Subsidence (per ASTM F2267-04) | Met predicate device performance standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document details mechanical testing of a medical implant, not a test set for an AI/ML algorithm. Therefore, information regarding "sample size for the test set" in the context of patients or data provenance is not applicable here. The "sample size" would refer to the number of physical devices tested. This information is not provided in the document.
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 is not applicable as the study involves mechanical testing of a physical device, not an AI/ML algorithm requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study involves mechanical testing of a physical device.
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
This is not applicable as the study involves mechanical testing of a physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the study involves mechanical testing of a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be established by the standardized methods outlined in ASTM F2077-14 and F2267-04. These standards define the test setup, loading conditions, and measurement techniques to objectively assess the mechanical performance characteristics (e.g., compression strength, shear stiffness, resistance to expulsion, and subsidence). The acceptance criteria are derived from the performance of the predicate devices against these objective measurements.
8. The sample size for the training set
This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the study involves mechanical testing of a physical device.
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Camber Spine Technologies % Paul Speidel Lead Regulatory Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913 April 18, 2018
Re: K173432
Trade/Device Name: ENZA™-A Titanium ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 6, 2018 Received: March 16, 2018
Dear Mr. Speidel:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173432
Device Name
ENZATM-A Titanium ALIF
Indications for Use (Describe)
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by pairent history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
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
Camber Spine Technologies ENZA™-A Titanium ALIF
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087 Phone: 484.318.8031
Contact Person: Mr. Damian Heinz Engineering Support Manager The Institute for Musculoskeletal Science and Education 418 E. LancasterAve. Wayne, PA 19087 Phone: 484.420.4286 Fax: 484.318.8031 Email: dheinz@imseinstitute.org
Date Prepared: April 18, 2018
Name of Device and Name/Address of Sponsor
Trade Name: ENZA™-A Titanium ALIF Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087
Common or Usual Name
Device Type: Intervertebral Fusion Device with Bone Graft, Lumbar
Classification Name
Intervertebral body fusion device (21 CFR 888.3080) (Product Code: OVD)
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Predicate Devices
The subject ENZA™-A Titanium ALIF device was demonstrated to be substantially equivalent to predicates Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device (K153720) and Camber Spine SPIRA Open Matrix ALIF Device (K162986) with respect to indications, design, materials, function, manufacturing, and/or performance.
The primary predicate device is ENZAZero-Profile Anterior Interbody Fusion Device (K153720).
Device Description
The Camber Spine Technologies ENZA™-A Titanium ALIF is an Interbody Fusion Device that has a hollow chamber to permit packing with autogenous graft material to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior and inferior anchoring plates. These implants may be implanted via a laparoscopic or an open anterior approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.
Intended Use / Indications for Use
The Camber Spine Technologies ENZA™-A Titanium ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discoqenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies ENZA™-A Titanium ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies ENZA™-A Titanium ALIF system must be used with autogenous graft material.
Technological Characteristics
The Camber Spine Technologies ENZA™-A Titanium ALIF is an Interbody Fusion Device that has spiral supportarches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.
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Performance Data
Testing performed indicate that the ENZA ™ - A Titanium ALIF is as mechanically soundas predicate devices. Testing included static compression, static compression-shear, dynamiccompression, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Substantial Equivalence
The ENZA ™-A Titanium ALIF is as safe and effective as the Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device (K153720) and Camber Spine SPIRA Open Matrix ALIF Device (K162986). The ENZA™-A Titanium ALIF has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technologicaldifferencesbetweentheENZA™-A Titanium ALIF anditspredicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that ENZA™-A Titanium ALIF is as safe and effective as Camber Spine ENZA Zero-Profile Anterior Interbody Fusion Device (K153720)and Camber Spine SPIRA Open Matrix ALIF Device (K162986). The ENZA™-A Titanium ALIF is substantially equivalent.
§ 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.