The TENORTM Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection.

Device Description

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross connectors, nuts, and screws made of medical grade titanium alloy. The TENOR™ Spinal System is used in conjunction with GDLH™ 5.5mm titanium alloy rods. Additionally, the TENOR™ Spinal System may be used with titanium alloy TSRH® hooks, TSRH® Low Profile CROSSLINK® plates, and MULTI AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

AI/ML Overview

The provided text is a 510(k) summary for the TENOR™ Spinal System. It details the device's description, indications for use, and a claim of substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or specific studies proving the device meets acceptance criteria.

The 510(k) process for devices like the TENOR™ Spinal System primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance metrics as might be seen for novel or high-risk devices.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and studies from the provided text.

Here's what I can infer from the document regarding the "proof" of the device:

Substantial Equivalence: The primary "proof" mentioned is the claim of substantial equivalence (Section V) to the CD™ Horizon, TSRH®, and DYNA-LOK® Spinal Systems. This is a regulatory pathway, not a clinical study demonstrating performance against a specific set of acceptance criteria.
Mechanical Testing: The document states, "Mechanical testing and other information were provided to demonstrate substantial equivalence." While mechanical testing is a type of study, the document does not elaborate on its details, such as specific tests performed, acceptance criteria for those tests, or the results.

To answer your questions, if this were a document that contained the requested information, it would typically appear in a "Performance Data," "Clinical Studies," or "Non-Clinical Studies" section, detailing the methodology, results, and comparison against pre-defined acceptance criteria. This information is absent in the provided 510(k) summary.

Summary

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OCT 5 1998

TENOR™ Spinal System 510(k) Summary K982490

I. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: II. TENOR™ Spinal System

III. Product Description

IV. Indications

The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

The TENORTM Spinal System, when used as a non-pedicle screw fixation system, is intended for the following indications: 1.) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2.)Pseudarthrosis, 3.) Stenosis, 4.) Spondylolisthesis, 5.) Spinal deformities: scoliosis, kyphosis, lordosis, 6.) Fracture, 7.) Unsuccessful previous attempts at spinal fusion, 8.) Tumor resection.

V. Substantial Equivalence

The TENOR™ Spinal System is substantially equivalent to the CD™ Horizon, TSRH®, and DYNA-LOK® Spinal Systems manufactured by Sofamor Danek. Mechanical testing and other information were provided to demonstrate substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1998

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K982490 TENOR™ Spinal System Requlatory Class: II Product Codes: MNH and KWP Dated: July 13, 1998 Received: July 17, 1998

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will werify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling. regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

M. Witten, Ph.D., M.D. Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K982490

TENOR™ Spinal System Device Name:

Indications for Use:

The TENORTM Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE

Evaluation (ODE)

Division Sion-Off ivision of General Restorative Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.