When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, 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).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using allograft and/or autograft: (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.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System Implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

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

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tallor-made for the individual case.

A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy and medical grade cobalt -chromium-molybdenum alloy.

TSRH® Spinal System staples are specifically excluded for use in pediatric patients.

Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and Vantage™ Anterior Fixation System screws.

The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.

AI/ML Overview

The provided document describes the Medtronic TSRH® Spinal System, a medical device for spinal fixation, and its 510(k) submission for an expanded indication for use in pediatric patients.

Here's an analysis of the acceptance criteria and study information contained within the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., specific thresholds for success, failure rates, or statistical significance levels). Instead, the performance is demonstrated through the concept of "substantial equivalence" to a predicate device and positive clinical data.

Acceptance Criterion (Implicit)	Reported Device Performance
Material Equivalence	The TSRH® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. This is implicitly accepted as equivalent to the predicate.
Mechanical Strength Equivalence	"The design features, material and mechanical strength of the TSRH® Spinal System are substantially equivalent to the CD HORIZON® Spinal System previously cleared in K091445 (S.E. 09/27/2010)." This affirms mechanical equivalence through substantial equivalence.
Design/Geometry Equivalence	"Therefore the subject TSRH® Spinal System is identical to the predicate TSRH® Spinal System in terms of device design, geometry, materials, sterilization, and intended use." This states design equivalence.
Sterilization Equivalence	"Therefore the subject TSRH® Spinal System is identical to the predicate TSRH® Spinal System in terms of device design, geometry, materials, sterilization, and intended use." This confirms sterilization equivalence.
Safety and Effectiveness for Expanded Pediatric Indication	"Published retrospective clinical data for pediatric patients diagnosed with adolescent idiopathic scoliosis and treated specifically with TSRH® Spinal System pedicle screw instrumentation was provided in support of this submission. The data included results of 40 pediatric patients treated with TSRH® pedicle screws only and 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws.""The safety and effectiveness of the TSRH® Spinal System for this expanded indication has been adequately supported by reported clinical results of this and similar devices which are contained within this premarket notification."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- 40 pediatric patients treated with TSRH® pedicle screws only.
- 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws.
- Total patients in the reported clinical data = 145 patients.
Data Provenance:
- Country of origin: Not explicitly stated.
- Retrospective or Prospective: "Published retrospective clinical data" indicates it was a retrospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish a "ground truth" for the clinical data in the context of a specific reader study or algorithm evaluation. Instead, the "truth" is based on the clinical outcome of the patients as documented in the retrospective data. It is implied that the diagnoses (adolescent idiopathic scoliosis) and treatment outcomes were established by the treating physicians and documented in patient medical records.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a process for adjudicating interpretations or measurements in the clinical data. The clinical data appears to be a record of patient treatments and outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document discusses a spinal system (an implantable device), not an imaging or diagnostic AI algorithm that would typically involve human readers. Therefore, there is no mention of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI without human intervention was not conducted. This document describes a physical medical device (spinal system), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the clinical data used to support the expanded indication is based on clinical outcomes data and patient diagnoses. Specifically:

Diagnosis of "adolescent idiopathic scoliosis."
Treatment with TSRH® Spinal System (pedicle screws or hybrid).
Presumably, the success or failure of the fusion and correction of scoliosis as observed in the clinical follow-up of these patients.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm that requires a training set. The clinical data mentioned is for validating the device's expanded indication, not for training a model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm in this context.

Summary

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JUN - 8 2011

TSRH® Spinal System 510(k) Summary

April 2011

l. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact: Lila Joe Sr. Regulatory Affairs Specialist

II. Proposed Proprietary Trade Name: TSRH® Spinal System

III. Classification Name(s): Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, and Pedicle Screw Spinal System (per 21CFR Section 888.3050, 888.3060, and/or 888.3070, respectively); Product Code(s): KWQ, KWP, MNI, MNH, NKB, OSH

lll. Description:

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

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cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy and medical grade cobalt -chromium-molybdenum alloy.

TSRH® Spinal System staples are specifically excluded for use in pediatric patients.

The purpose of this 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.

V. Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterlor spine in skeletally mature patients using autograft and/or allograft, 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) scollosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

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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 deformittles (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scollosis, kyphosis and/or lordosis); turnor; pseudarthritis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System Implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The TSRH® Pediatric Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

VI. Clinical Asessment

Published retrospective clinical data for pediatric patients diagnosed with adolescent idiopathic scoliosis and treated specifically with TSRH® Spinal System pedicle screw instrumentation was provided in support of this submission. The data included results of 40 pediatric patients treated with TSRH® pedicle screws only and 105 pediatric patients treated with a hybrid of TSRH® hooks and pedicle screws.

VII. Substantial Equivalence:

The design features, material and mechanical strength of the TSRH® Spinal System are substantially equivalent to the CD HORIZON® Spinal System previously cleared in K091445 (S.E. 09/27/2010). No new implants have been included in this submission as the purpose is only to expand the indication for posterior pedicle screw constructs previously cleared by FDA for use in pediatric patients diagnosed

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with adolescent idlopathic scollosis. Therefore the subject TSRH® Spinal System is identical to the predicate TSRH® Spinal System in terms of device design, geometry, materials, sterilization, and intended use. The safety and effectiveness of the TSRH® Spinal System for this expanded indication has been adequately supported by reported clinical results of this and similar devices which are contained within this premarket notification.

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Image /page/4/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" around the edge. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2013

Medtronic Sofamor Danek % Ms. Lila Joe Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K110070

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, OSH, MNI, MNH, KWP, KWQ Dated: June 02, 2011 Received: June 03, 2011

Dear Ms. Joe:

This letter corrects our substantially equivalent letter of June 8, 2011.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Lila Joe

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerely yours.

Image /page/5/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The last name, "Keith," is written in a more decorative font that incorporates geometric shapes and patterns.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K110070

Device Name: ISRH® Spinal System

Indications for Use:

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (1.5-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) turnor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System is intended to be used with allograft and/or autgraft. Pedlatric pedicie screw fixation is limited to a posterior approach.

Prescription Use _ X OR Per 21 CFR 801.109

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)on of Surgical. Orthopedic. Restorative Devices

KI10070 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.