When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (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) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and (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: (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 (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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral/anterior 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and into anterior vertebral bodies of the cervical spine.

Device Description

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 PLUSTM 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

Here's an analysis of the provided text regarding the TSRH® Spinal System 510(k) Summary, focusing on acceptance criteria and the supporting study:

Important Note: The provided document is a 510(k) summary for a medical device (spinal system components), specifically concerning the incorporation of additional screw sizes. This type of submission does not typically include detailed performance studies with human subjects or AI algorithms in the way you might expect for an AI/ML medical device. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device through mechanical testing and comparison of design and materials.

Therefore, many of your requested fields related to AI/ML device studies (such as MRMC studies, sample sizes for training/test sets, ground truth establishment for AI, etc.) are not applicable to this document. I will fill in what can be gleaned from the text and explicitly state when information is not available or not relevant to this type of device submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Substantial Equivalence (General)	Device is substantially equivalent to a legally marketed predicate device.	The TSRH®-3D screws were declared substantially equivalent to: - CD® Spinal System 4.0mm screws - TSRH® Spinal System (manufactured by Medtronic Sofamor Danek)
Mechanical Performance	(Implied: Mechanical performance comparable to predicate device for safety and effectiveness.)	"Mechanical test data was provided in this application."
Materials	Conformance to specified ASTM/ISO standards for medical grade materials.	Components fabricated from: - Stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9 - Medical grade titanium alloy conforming to ASTM F-136 or ISO 5832-3 - Medical grade titanium conforming to ASTM F67
Indications for Use (Scope)	Indications for Use for the new components are consistent with or equivalent to predicate.	Indications for Use cover pedicle screw fixation, posterior non-pedicle screw fixation, and anterolateral/anterior systems for various spinal conditions, consistent with the TSRH® Spinal System.

Study Details (Based on available information in the 510(k) Summary)

Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This 510(k) summary pertains to mechanical testing for substantial equivalence, not a clinical study on human subjects with a "test set" in the context of AI/ML. The "test set" would refer to the mechanical specimens tested.
- Data Provenance: The mechanical test data would have been generated internally by Medtronic Sofamor Danek, likely in a controlled laboratory setting. The country of origin for such data is typically the country where the manufacturer performs its testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical testing of medical device components, "ground truth" is established through engineering specifications, validated test methods (e.g., ASTM standards), and material properties, rather than expert consensus on medical images or patient outcomes. The "experts" would be materials scientists, mechanical engineers, and quality assurance personnel.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical data (e.g., radiology reads) to establish a consensus ground truth. This is not relevant to mechanical testing.
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. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images with or without AI-assistance). This is not applicable to a spinal implant system like the TSRH® Spinal System.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a physical spinal implant; it does not involve any algorithms or AI for standalone performance evaluation in the way an AI/ML diagnostic device would.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the purpose of this 510(k), the "ground truth" for demonstrating substantial equivalence for the new screw sizes relies on mechanical performance data (e.g., strength, fatigue resistance) meeting established engineering standards and being comparable to the predicate devices. It is also based on material specifications (conformance to ASTM/ISO standards).
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.

Summary of the Study (as implied by the 510(k) submission):

The "study" for this 510(k) submission was primarily a mechanical testing and comparative analysis study. The objective was to demonstrate that the new TSRH®-3D screw sizes are substantially equivalent to established predicate devices (CD® Spinal System 4.0mm screws and the existing TSRH® Spinal System manufactured by Medtronic Sofamor Danek).

This involved:

Design and Material Comparison: Detailed analysis of the design (e.g., geometry, screw thread patterns, dimensions) and materials used for the new screws compared to the predicates.
Mechanical Testing: Performance of various mechanical tests on the new screw sizes to ensure they meet the same or equivalent biomechanical performance standards (e.g., pull-out strength, bending fatigue, torsional strength) as the predicate devices. The document explicitly states "Mechanical test data was provided in this application." This data would serve as the primary evidence for meeting the implicit "acceptance criteria" of comparable mechanical performance.
Indications for Use Comparison: Ensuring the proposed Indications for Use for the new screws were consistent with those already cleared for the predicate devices.

Conclusion: The 510(k) process for a device like the TSRH® Spinal System fundamentally relies on comparing a new device (or modification) to an already legally marketed "predicate" device. The acceptance criteria are largely met by demonstrating that the new device is as safe and effective as the predicate, which for a spinal implant primarily involves material conformance and mechanical performance testing. It does not involve AI/ML performance metrics or human reader studies.

Summary

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K021170

TSRH® Spinal System 510(k) Summary June 2002

JUL 9 2002

Medtronic Sofamor Danek USA, Inc. I. Company: 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 incorporate additional TSRH®-3D screw sizes into the system.

IV. Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is intended for immobilization and

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stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (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) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and (8) failed previous fusion (pseudarthrosis).

The TSRH®-3D screws were declared substantially equivalent to the CD® Spinal V. System 4.0mm screws and to the TSRH® Spinal System manufactured by Medtronic Sofamor Danek. Mechanical test data was provided in this application.
© 2002 Medtronic Sofamor Danek

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered in the image. The words are stacked on one line.

Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

ப்பட 9 2002

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

Re: K021170

TSRH® Spinal System - 3D Screws 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 Regulatory Class: II Product Codes: KWP; KWQ; MNI; and MNH Dated: April 10, 2002 Received: April 12, 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, 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 (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

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

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.

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 vou 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,

Neil R P Ogden

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): KO21170

TSRH® Spinal System Device Name:

Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (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) degenerative spondylolisthesis with objective evidence of neurologic impairment. (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and (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: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst 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 (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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral/anterior 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis. (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and into anterior vertebral bodies of the cervical spine.

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

Concurrence of CDRH, Office of Evaluation (ODE)

NKo for cmw

Jivision Sign=C vision of General, Restorative and Neurological Devices

510(k) Number K021170
OR Over-the-counter Use

Prescription Use X (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.