When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) turnor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

Device Description

The purpose of this 510(k) submission is to add modified TSRH® Spinal System Screws to the TSRH® Spinal System.

The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNALOK PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only.

The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The TSRH® Spinal System may be sold sterile or non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (TSRH® Spinal System) and the FDA's clearance letter. This type of document is a premarket notification for devices that are "substantially equivalent" to an already legally marketed device. It does not typically contain information about formal acceptance criteria or detailed studies proving device performance against such criteria in the same way a new, high-risk device might.

Instead, the primary "study" and "acceptance criteria" here revolve around demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting what is and isn't present:

Acceptance Criteria and Device Performance Study (TSRH® Spinal System)

The regulatory pathway for the TSRH® Spinal System, as described in the 510(k) summary, is based on demonstrating substantial equivalence to a previously cleared predicate device. This means the "acceptance criteria" are intrinsically tied to showing that the new device shares similar technological characteristics and/or indications for use with the predicate, without raising new questions of safety or effectiveness.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance
Technological Characteristics: Demonstrate similar materials, design, and operating principles to a legally marketed predicate device.	The TSRH® Spinal System consists of rods, hooks, screws, cross connectors, and connecting components, fabricated from stainless steel, medical grade titanium alloy, or medical grade titanium. These components are described as similar to the previously cleared TSRH® Spinal System screws. The 510(k) specifically adds "modified TSRH® Spinal System Screws" to the existing system, implying a direct comparison of these modifications to the predicate.
Indications for Use: Demonstrate similar intended uses as a legally marketed predicate device.	The indications for use for the modified TSRH® screws are identical to the previously cleared TSRH® Spinal System. These include:
	As a pedicle screw fixation system (non-cervical, mature patients): Degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
	Additional pedicle screw indications (skeletally mature, L5-S1): Severe spondylolisthesis (Grades 3 and 4), fusions with autogenous bone graft only, device fixed to L3 and below, device removal after solid fusion mass.
	As a posterior, non-cervical, non-pedicle screw fixation system: Degenerative disc disease, spondylolisthesis, fracture, spinal deformities (scoliosis, kyphosis, lordosis), spinal stenosis, pseudarthrosis, tumor resection, unsuccessful previous attempts at spinal fusion.
	For anterior use only: Spinal stenosis, spondylolysis.
Safety and Effectiveness: Demonstrate that the device is as safe and effective as the predicate device and does not raise new questions of safety or effectiveness.	The document explicitly states: "The subject TSRH® screws were demonstrated to be substantially equivalent to previously cleared TSRH® Spinal System screws manufactured by Medtronic Sofamor Danek. A risk analysis was provided in support of this application." This statement serves as the primary "proof" of meeting safety and effectiveness criteria relative to the predicate device within the 510(k) framework. No specific performance metrics (e.g., strength, fatigue life, biological response) are detailed in this summary, but these would have been part of the risk analysis and comparison to the predicate.

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

The provided text does not include information about a "test set" in the context of clinical or performance data for the modified screws. For a 510(k) submission focused on substantial equivalence, the "test set" is often the comparison of the new device's specifications (design, materials, indications) against the predicate device's specifications.

Sample Size for Test Set: Not applicable/not provided for a clinical or performance study. The "sample" here refers to the specific modified TSRH® screws being compared to the predicate.
Data Provenance: Not applicable/not provided for a clinical or performance study. Comparisons would be based on internal design and testing data against predicate data.

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

This information is not provided in the 510(k) summary. For substantial equivalence, the "ground truth" is largely established by regulatory precedent (the predicate device's clearance) and engineering/risk analysis rather than expert clinical consensus on a new test set.

4. Adjudication method

Not applicable/not provided. There is no mention of a human-reviewed test set or an adjudication process in this summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. MRMC studies are typically for evaluating the diagnostic performance of software or imaging devices, not for surgical implants like spinal systems.

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

Not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the predicate device. The modified TSRH® screws are deemed safe and effective if they are "substantially equivalent" to this predicate, meaning they share the same fundamental characteristics and indications for use without raising new safety concerns.

8. The sample size for the training set

Not applicable. There is no training set in the context of an AI/algorithm. For a medical device implant, the "training" would be the development and testing data that led to the original TSRH® Spinal System, but this specific information is not in the summary for the modified screws.

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

Not applicable. There is no training set mentioned. The "ground truth" for the predicate device would have been established through its own 510(k) clearance or other regulatory pathways, which would have involved demonstrating its safety and effectiveness (e.g., through performance testing, biocompatibility, and potentially clinical data, although often not required for 510(k)). This information is not detailed for the predicate in this document.

Summary

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K041282
page 1 of 2

TSRH® Spinal System 510(k) Summary May 2004

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: TSRH® Spinal System II.

Regulation Numbers: 888.3050, 888.3060 and 888.3070

Regulation Names: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System, and Pedicle Screw Spinal System.

Codes: NKB, KWP, MNH and MNI

III. Description

The purpose of this 510(k) submission is to add modified TSRH® Spinal System Screws to the TSRH® Spinal System.

The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

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IV. Indications for Use:

041282
page 2 of 2

When used as a pedicle screw fixation system in the non-cervical mature patients, the TSRH® System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) turnor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

The subject TSRH® screws were demonstrated to be substantially equivalent to previously cleared TSRH® Spinal System screws manufactured by Medtronic Sofamor Danek. A risk analysis was provided in support of this application.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a river or stream.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

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

Re: K041282

Trade/Device Name: TSRH® Spinal System Trade/Device Name: "FBRT" 8px.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWP, MNI, MNH, NKB Dated: May 11, 2004 Received: May 13, 2004

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegally to tegally the Medical Device Amendments, or to connineres proct to may 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices marc Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette (110) the (110) that the device, subject to the general controls provisions of the Act. The r via may, merclore, market of the Act include requirements for annual registration, listing of general controls proficions of tactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clusined (500 abor 0) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may oc subject to such additions, 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 I lease be advised that I Dr i risean that your device complies with other requirements of the Act that i Dri has intates and regulations administered by other Federal agencies. You must or any I cacal statutes and regulations, including, but not limited to: registration and listing (21 Comply with an the Precessories, on and 801); good manufacturing practice requirements as set CI K Fart 6077, noomig (21 CFR Part 820); and if applicable, the electronic form in the quand by bystel provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to begin marketing your antial equivalence of your device to a legally premaired 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), please in you atent office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general s. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N. Millkenso

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K041282

Device Name:

TSRH® Spinal System

Indications for Use:

Indications for Use.
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Melhusen

Division of General, Restorative, and Neurological Devices

510(k) Number K041282

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.