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 (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.

TENOR™ Plates are intended for the LS-S I pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc discase (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. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (TI - Sacrum) fixation only.

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, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORTM Spinal System may be used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and/or MULTI AXIAL Low Profile MULTI-SPANTM 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. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The statement "Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself" is a very unusual and likely erroneous statement within the context of a 510(k). Typically, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. This implies that the device is either (a) a re-submission of a previously cleared device with minor changes, or (b) the sentence is a typo and refers to a known predicate device that is not explicitly named here. Without further documentation, it's impossible to determine the true basis for substantial equivalence.

Therefore, I cannot fulfill your request for the detailed breakdowns of acceptance criteria, study methodologies, and performance metrics as this information is not present in the provided text.

Here's a breakdown of what is and is not available in the provided document, in relation to your request:

1. Table of acceptance criteria and the reported device performance:

Not provided. The document states that the system is "substantially equivalent" but does not offer specific performance metrics or acceptance criteria for those metrics.

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

Not provided. No information about a test set, its sample size, or data provenance is present.

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

Not provided. There is no mention of a test set, ground truth, or experts establishing it.

4. Adjudication method for the test set:

Not provided. No information about a test set or adjudication method is present.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not provided. This device is a mechanical spinal system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human-AI collaboration is irrelevant. No information about any comparative effectiveness study is provided.

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

Not applicable/Not provided. As stated above, this is a mechanical device, not an algorithm. No standalone performance data is provided for the device in general.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not provided. No information about ground truth is present.

8. The sample size for the training set:

Not applicable/Not provided. As a mechanical device, there wouldn't typically be a "training set" in the sense of machine learning. There is no information about any study sample sizes.

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

Not applicable/Not provided. There is no mention of a training set or its ground truth.

In summary, the provided 510(k) pertains to regulatory clearance based on substantial equivalence, and it does not include the detailed study results or performance data that would typically be found in a clinical study report or a more comprehensive technical document.

Summary

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MAY 19 1125

TENOR™ Spinal System - K991364 510(k) Summary May 13th, 1999

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

TENOR™ Spinal System Proposed Proprietary Trade Name: II.

Product Description III.

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.

TENOR™ Plates are intended for the LS-S1 pedicle screw indication described above only.

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, lordosis, 6.) Fracture, 7.) Unsuccessful previous attempts at spinal fusion, 8.) Turnor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.

Substantial Equivalence V.

Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1999

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

K991364 Re: TENOR™ Spinal System Trade Name: K991460 ZPlate-ATL™ Anterior Fixation System Trade Name: Requlatory Class: II Product Codes: MNH and KWP Dated: April 19 and 26, 1999 Received: April 20 and 27, 1999

Dear Dr. Treharne:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Reqister. Please note: this response to your premarket notification submission does

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

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.

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

If you desire specific advice for your devices on our labeling requlation (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 devices, 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 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,

Celia M. Witten, Ph.D., M.

Cella M. Witten, Bh.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Page 1 of 1 May 13th, 1999

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K991364

TENORTM Spinal System Device Name:_

Indications for Use:

TENOR™ Plates are intended for the LS-S I pedicle screw indication described above only.

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

Concurrence of CDRH, Office of Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K991960
510(k) Number.

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

ver-the-counter Use

Regulation Number and Section

N/A