MODIFICATION TO ISOLA SPINAL SYSTEM by DEPUY ACROMED

The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spine System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The nonpedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

The Anterior ISOLA Spine System is intended for use in correcting scolictic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA Spine System is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

Collapsing and unstable paralytic deformity
Progressively increasing scollosis.
Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
Inability to maintain sitting balance, necessitating the use of the hands.
Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
Spinal fractures (acute reduction or late deformity).
Degenerative Disc Disease (Defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
Spinal turnor.
Previous failed fusion surgery.

Spinal levels for Anterior ISOLA are from T5-L4.

Device Description

The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spinal System. The ISOLA Spine System is manufactured from either stainless steel conforming to ASTM F-138 or F-1314 specifications, or titanium alloy conforming to ASTM F-136 specifications.

AI/ML Overview

Here's an analysis of the provided text regarding the ISOLA Spinal System's acceptance criteria and studies:

Based on the provided document, the "ISOLA Spinal System" is a medical device, specifically a spinal fixation system, cleared through a 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the same way a PMA (Premarket Approval) submission would.

Therefore, the "acceptance criteria" and "study" described in the input refer to the performance data provided to demonstrate substantial equivalence to previously cleared devices, not a clinical study proving device performance against specific, pre-defined outcome criteria in a patient population.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit - based on 510(k) requirements for spinal fixation systems):
For spinal fixation systems in a 510(k) submission, the primary acceptance criteria for performance data revolve around demonstrating that the mechanical properties of the new device are at least equivalent to or better than those of previously cleared predicate devices under similar testing conditions. This typically involves:

Static Mechanical Performance: Ability to withstand applied loads without permanent deformation or failure.
Fatigue Mechanical Performance: Ability to withstand cyclic loading for a specified number of cycles without failure, simulating the stresses of in vivo use over time.

Reported Device Performance:

Acceptance Criteria Category	Specific Metric (Implicit)	Reported Performance
Mechanical Performance	Static strength and resistance to deformation	"perform consistently with previously cleared components"
Durability/Longevity	Fatigue life under cyclic loading (e.g., number of cycles)	"perform consistently with previously cleared components"
Material Compatibility	Biocompatibility and material properties	Conforming to ASTM F-138/F-1314 (stainless steel) or ASTM F-136 (titanium alloy) specifications.

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

Sample Size for Test Set: Not explicitly stated in terms of the number of device constructs tested. The description simply refers to "constructs of the ISOLA Spinal System."
Data Provenance: Not explicitly stated. This "performance data" refers to in-vitro mechanical testing, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The performance data is based on engineering mechanical tests, not expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

Not applicable. As this involves mechanical testing, there is no "adjudication method" in the sense of reconciling different expert opinions. The outcome is determined by physical measurements and material science principles.

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

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a spinal implant, which relies on mechanical testing to demonstrate substantial equivalence, not clinical effectiveness studies comparing human readers with and without AI. AI is not mentioned in this document.

6. Standalone Performance (Algorithm Only)

No. This is not an AI-driven device. The "performance data" relates to the mechanical properties of the physical spinal implant.

7. Type of Ground Truth Used

Mechanical Testing Standards/Specifications: The "ground truth" for this device's performance is established by recognized engineering and material science standards (e.g., ASTM standards for materials) and internal test protocols designed to simulate in vivo conditions, allowing for comparison to predicate devices' performance data. The explicit statement is "Static and fatigue testing show the constructs of the ISOLA Spinal System to perform consistently with previously cleared components."

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires "training data."

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

Not applicable. Again, this is not an AI/machine learning device.

Summary and Context:

The 510(k) process is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. For implants like the ISOLA Spinal System, this typically means showing that its materials, design, and mechanical performance are comparable to devices already on the market. The provided text confirms this through the statement: "Static and fatigue testing show the constructs of the ISOLA Spinal System to perform consistently with previously cleared components." This demonstrates that the device meets the implicit acceptance criteria of being mechanically equivalent to established devices in its class.

Summary

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K993030

ISOLA SPINAL SYSTEM DEC 2 9 1999 Pedicle Screw Indications 510(k) SUMMARY

SUBMITTER: DePuy AcroMed 325 Paramount Drive Raynham, MA 02767-0350
CONTACT PERSON: William Christianson

September 29, 1999 DATE PREPARED:

Spinal Interlaminal Fixation Orthosis CLASSIFICATION NAME: Pedicle Screw Spinal System

Spinal Fixation System COMMON NAME:

PROPRIETARY NAME: ISOLA Spinal System

The primary purpose of this premarket notification is to DESCRIPTION: add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spinal System

The Posterior ISOLA Spinal System, when used with INTENDED USE: pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spine System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

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PACE 2 OF 2

The Anterior ISOLA Spine System is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

1. Collapsing and unstable paralytic deformity
1. Progressively increasing scollosis.
Decreasing cardio-respiratory function, secondary to 3. spinal or rib deformity or collapse.
Inability to maintain sitting balance, necessitating the 4. use of the hands.
Increasing pelvic obliquity coincident with back pain or 5. loss of sitting balance.
Spinal fractures (acute reduction or late deformity). 6.
Degenerative Disc Disease (Defined as discogenic 7. back pain with degeneration of the disc confirmed by history and radiographic studies).
Spinal tumor. 8.
1. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA are from T5-L4.

MATERIALS: The ISOLA Spine System is manufactured from either stainless steel conforming to ASTM F-138 or F-1314 specifications, or titanium alloy conforming to ASTM F-136 specifications.

PERFORMANCE DATA:

Static and fatigue testing show the constructs of the ISOLA Spinal System to perform consistently with previously cleared components.

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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 stylized eagle with three lines representing its body and wings. The eagle is facing right and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Ms. Karen F. Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K993030 Trade Name: ISOLA Spinal System Regulatory Class: II, III Product Code: KWO. KWP. MNH and MNI Dated: September 30, 1999 Received: October 1, 1999

Dear Ms. Jurczak:

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 (QS) 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 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.

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Page 2 - Ms. Karen F. Jurczak

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thos. C. Lyon

Sar James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II.

510(k) Number (if known): K993030

ISOLA Spinal System Device Name:

Indications For Use:

1. Collapsing and unstable paralytic deformity
1. Progressively increasing scollosis.
1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
1. Inability to maintain sitting balance, necessitating the use of the hands.
1. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
1. Spinal fractures (acute reduction or late deformity).
1. Degenerative Disc Disease (Defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
1. Spinal turnor.
1. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA are from T5-L4.

Russell L. Rogers Jr.

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.