The SSCS (Segmental Spinal Correction System) is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracic-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.

When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; previously failed attempts at spinal fusion.

When used as a pedicle screw system in the thoracolumbosacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw system, the SSCS is intended for patients:

1. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
1. Who are receiving fusions using autogenous bone graft only.
1. Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below).
1. Who are having the device removed after the development of a solid fusion mass.

Device Description

The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems. the SSCS is comprised basically of 1) bone screws and hooks for attachment of the device to the spine, 2) longitudinal rods that are attached to the bone screws and hooks either directly or indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

AI/ML Overview

This document describes a 510(k) submission for a medical device, the SSCS (Segmental Spinal Correction System), which is a posterior spinal fixation device. For spinal fixation devices, the "acceptance criteria" and "device performance" are typically defined by mechanical testing standards rather than diagnostic accuracy metrics seen in AI/imaging devices.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Details for the SSCS (Segmental Spinal Correction System)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Required Performance)	Reported Device Performance
Mechanical performance characteristics:	The test results demonstrated that the mechanical performance characteristics
- Bending-compression static strength	(bending-compression static strength and stiffness, torsional stiffness and
- Bending-compression static stiffness	fatigue strength) of SSCS constructs are at least comparable to, if not better than, those of the predicate devices.
- Torsional stiffness
- Fatigue strength
Standard: In accordance with the ASTM Standard for testing spinal implant devices.

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

The document does not specify a sample size for the mechanical testing. It mentions "SSCS constructs," implying multiple test specimens were used, but the exact number is not provided.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Mechanical testing of a device itself is not typically classified as retrospective or prospective in the same way clinical trials are.

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

This question is not applicable in the context of this device. The "ground truth" for a spinal fixation device's mechanical performance is defined by established engineering test standards (ASTM standards), not by human expert consensus or clinical evaluations.

4. Adjudication Method for the Test Set:

This question is not applicable. Mechanical testing results are objective measurements based on standardized protocols, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This submission concerns a physical implantable device, and its performance is evaluated through mechanical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in spirit. The mechanical performance testing of the SSCS constructs is a standalone evaluation of the device itself, without human intervention affecting the measurement of its mechanical properties. The "algorithm" in this context is the physical device's design and material properties.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the SSCS device's performance is established engineering standards and objective mechanical measurements. Specifically, the "ASTM Standard for testing spinal implant devices" serves as the reference for acceptable performance. The comparison also references the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" for the mechanical testing of a physical medical device. This concept applies to machine learning algorithms.

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

This question is not applicable for the same reasons as #8.

Summary

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VIII. 510(k) Summary of Safety and Effectiveness

1. Submission Applicant & Correspondent:
  Name: Address:

Phone No .: Contact Person:

Osteotech, Inc. 51 James Way Eatontown, NJ 07724 (732) 542-2800 Christopher Talbot

Date of Summary:

May 6, 1999

1. Name of Device:
  SSCS (Segmental Spinal Trade/Proprietary/Model Name: Correction System)

Common or Usual Name:

Classification Name:

Spinal Interlaminal Fixation Orthosis; Spondylolisthesis Spinal Fixation Device System; Pedicle Screw Fixation System

Posterior Spinal Fixation Device

Devices to Which New Device is Substantially Equivalent:

The SSCS is substantially equivalent, for the purpose of this 510(k) adding indications, to the following predicate devices.

Trade/Proprietary/Model Name	Manufacturer
SSCS	Heinrich C. Ulrich
ISOLA	AcroMed
TSRH	Sofamor-Danek

Device Description:

K991586

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segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

5. Intended Use/Indications

The Segmental Spinal Correction System (SSCS) is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracic-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.

In addition, when used as a pedicle screw system, the SSCS is intended for patients:

1. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
1. Who are receiving fusions using autogenous bone graft only.
1. Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below).
1. Who are having the device removed after the development of a solid fusion mass.

6. Performance Data

Mechanical testing of SSCS constructs was performed in accordance with the ASTM Standard for testing spinal implant devices. The test results demonstrated that the mechanical performance characteristics (bending-compression static strength and stiffness, torsional stiffness and fatigue strength) of SSCS constructs are at least comparable to, if not better than, those of the predicate devices.

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 1999

Mr. Christopher W. Talbot Director of Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, New Jersey 07724

Re: K991586

Trade Name: Segmental Spinal Correction System Regulatory Class: II Product Code: KWP, MNI and MNH Dated: May 6, 1999 Received: May 7, 1999

Dear Mr. Talbot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other

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Page 2 -- Mr. Christopher W. Talbot

Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

C. Keith Wilson, Ph.D., M.D.

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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I. Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: SSCS (Segmental Spinal Correction System)

Indications for Use:

The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows:

1. When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; and previously failed attempts at spinal fusion.
1. When used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
1. In addition, when used as a pedicle screw system, the SSCS is intended for patients:
- a. Having severe spondylolisthesis (grade 3 or 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 (level of attachment: L3 and below).
- d. Who are having the device removed after the development of a solid fusion mass.

(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 Devices
510(k) Number	K991586

Prescription Use >> (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

N/A