When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal 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 imparment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, 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) tumor 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 a variety of modified TSRH® components (rods, screws and connectors) to the 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® 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. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, they may be fabricated from medical grade titanium alloy conforming to ASTM F-136 or ISO 5832-3 or medical grade titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the TSRH Spinal System, an orthopedic implant. It describes the device's indications for use and states that the components were declared substantially equivalent to previously cleared components.

However, the document specifically states that a "Failure Mode and Effects Criticality Analysis/Design Verification" was provided. It does not include information about specific acceptance criteria or a study proving that the device meets those criteria, especially in the context of device performance as one might expect for a digital health or AI-driven medical device. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against pre-defined acceptance criteria as would be required for a novel device or AI product.

Therefore, many of the requested fields cannot be answered from the provided text because they pertain to a type of device performance evaluation that is not detailed in this 510(k) summary for a spinal implant system.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not present:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document. The 510(k) focuses on substantial equivalence based on a "Failure Mode and Effects Criticality Analysis/Design Verification" for the physical components, not performance metrics like accuracy, sensitivity, or specificity.	Not specified in the document. No quantitative performance metrics are provided. The device's "performance" is implicitly tied to its substantial equivalence to predicate devices and being able to fulfill its stated indications for use as an adjunct to spinal fusion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not applicable and not mentioned. This type of information would be relevant for clinical performance studies, which are not detailed in this 510(k) summary. The "test set" for this type of substantial equivalence submission primarily involves engineering design verification/validation (e.g., mechanical testing, material characterization), not a clinical data set in the same way an AI product would.
Data provenance: Not applicable and not mentioned.

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)

Not applicable and not mentioned. This is typically relevant for clinical studies where expert consensus might define a ground truth for diagnostic accuracy, which is not the subject of this 510(k). The "ground truth" for the TSRH Spinal System would be its mechanical integrity and biocompatibility, as confirmed through design verification processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. This is relevant for AI-assisted diagnostic devices, which is not what the TSRH Spinal System is.

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

Not applicable and not mentioned. The TSRH Spinal System is a physical orthopedic implant, not an algorithm.

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

The document implies that the ground truth for the device's acceptable performance is its substantial equivalence to predicate devices and adherence to established material and mechanical standards (e.g., ASTM F-138, ISO 5832-1, ASTM F-136). The "Failure Mode and Effects Criticality Analysis/Design Verification" mentioned would likely involve engineering analyses and testing against established safety and performance benchmarks for spinal implants, rather than clinical ground truth as defined by pathology or outcomes data in a prospective study for a novel device.

8. The sample size for the training set

Not applicable and not mentioned. This applies to machine learning models, not physical orthopedic implants.

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

Not applicable and not mentioned.

Summary

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K U 22778 y p1/2

SEP 1 8 2002

TSRH® Spinal System 510(k) Summary August 2002

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

Proposed Proprietary Trade Name: TSRH® Spinal System II.

III. Description

The purpose of this 510(k) submission is to add a variety of modified TSRH® components (rods, screws and connectors) to the 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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K022778 p²/2

titanium conforming to ASTM F67. The TSRH® Spinal System may be sold sterile or non-sterile.

IV. Indications for Use:

When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal 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 tumor, 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.

V. The subject TSRH® components were declared substantially equivalent to previously cleared TSRH® Spinal System components. A Failure Mode and Effects Criticality Analysis/Design Verification was provided in this application.
© 2002 Medtronic Sofamor Danek

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Scnior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place SEP 1 8 2002 Memphis, Tennessee 38132

Re: K022778

Trade/Device Name: TSRH® Spinal System Regulatory Number: 21 CFR 888.3070(b)(1), 21 CFR 888.3050, 21CFR 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: III Product Code: MNI, MNH, KWP, KWQ Dated: August 21, 2002 Received: August 22, 2002

Dear Dr. Treharne:

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. Iisting 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 (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Richard W. Treharne

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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.

Celia 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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K022778 510(k) Number (if known):_

TSRH® Spinal System Device Name:

Indications for Use:

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 (1.5-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 (13 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, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor 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.

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

Concurrence of CDRH, Office of Evaluation (ODE)

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

OR
Over-the-counter Use __

ision Sign-Off) on of General, Restorative Neurological Devices 510(k) Number

Regulation Number and Section

N/A