When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spina! 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).

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) vertebral 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 TSRH® Spinal System is intended to help provide immobilization 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

This document is a 510(k) summary for the TSRH® Spinal System, outlining its re-submission to add modified connectors. It does not contain information about acceptance criteria or specific studies demonstrating device performance against such criteria. Instead, it focuses on arguing for "substantial equivalence" to previously cleared devices without requiring new clinical testing.

Therefore, most of your requested information cannot be extracted from this document, as it explicitly states "This submission reflects merely a wording change and therefore no additional testing is required."

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document states "no additional testing is required" because the submission is for a "wording change" and modified connectors, which do not "alter the safety and effectiveness of the device." Therefore, no new performance data or acceptance criteria are presented for this specific submission. The established performance and safety are implicitly linked to the predicate devices.

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

Cannot be provided. No new test set data was generated or used for this submission.

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)

Cannot be provided. No new test set data was generated or used for this submission, and therefore no ground truth establishment exercise is described.

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

Cannot be provided. No new test set data was generated or used for this submission.

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

Cannot be provided. This document concerns a spinal implant system, not an AI-assisted diagnostic tool.

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

Cannot be provided. This document concerns a spinal implant system, not an algorithm.

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

Cannot be provided. No new ground truth was established for this submission. The safety and effectiveness are established through substantial equivalence to predicate devices, which would have had prior clinical data or engineering tests.

8. The sample size for the training set

Cannot be provided. No "training set" in the context of an algorithm or machine learning is relevant to this device submission.

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

Cannot be provided. No "training set" in the context of an algorithm or machine learning is relevant to this device submission.

Summary of the document's relevance to your questions:

The document clearly states that "no additional testing is required" for this specific 510(k) submission (K062807). The basis for clearance is "wording change" in the indications for use and modified connectors, and the assertion that these changes "do not alter the safety and effectiveness of the device." The submission relies on "substantial equivalence" to previously cleared predicate devices (K030033 and K052151). Therefore, the information you're requesting regarding new studies, acceptance criteria, sample sizes, and expert adjudications is not present in this document because such studies were explicitly deemed unnecessary for this submission.

Summary

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Image /page/0/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K062807". The characters are written in a bold, somewhat stylized font, with some characters connected.

TSRH® Spinal System 510(k) Summary September 2006

NOV - 6 2006

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Edward S. Chin, D. Ph, MBA Contact: Group Director, Regulatory and Clinical Affairs
Proposed Proprietary Trade Name: TSRH® Spinal System II.

Classification Name(s)/Product Code(s): 111.

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

Regulation Numbers: 888.3050, 888.3060 and 888.3070

Product Codes: NKB, KWP, MNH and MNI

IV. Description

The purpose of this 510(k) submission is to add modified connectors to the TSRH® Spinal System. The TSRH® Spinal System is intended to help provide immobilization 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.

V. 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).

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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 frankly hus her System is intended for the following indications: (1) degenerative disc disease (as defined by back System is intended for the forlowing millettions. (1) assnfirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyposis, and/or studies), (2) spondylonstilesis, (5) fracture, (7) sphar determines (7) ", "1) unsuccessful previous attempts at spinal fusion.

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

Substantial Equivalence VI.

Substantial Equivalence
This submission reflects merely a wording change and therefore no additional testing is required. The This Submission reneces insert and to the wording of the indications of use do not alter the safety modifications to the package insert and to the werening of the patient. Wording for and enectiveliess of the device, nor do they inflood any in package inserts for similar spinal device and the modified communications is equivalent to that 18ths 19ths 1950s3, SE 02/26/03) and the System metading anive Spine System (Synthes - K052151, SE 12/07/05).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek, Inc. % Edward Chin, D.Ph, MBA Group Director, Regulatory and Clinical Affairs 1800 Pyramid Place Memphis, Tennessee 38132

NOV - 6 2006

Re: K062807

Trade/Device Name: TSRH® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: September 18, 2006 Received: September 19, 2006

Dear Dr. Chin:

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 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 - Edward Chin, D.Ph, MBA

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), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Ouliane Boucher

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko6.2807 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D)

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)

(Division Sign-Off Division of General, Restorative. and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.