The ISSYS LP Spinal Fixation System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The ISSYS LP Spinal Fixation System is also 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 sever spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

· Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
o Spondylolisthesis
Fracture o
Spinal deformities such as scoliosis, kyphosis, lordosis o
o Tumor
Revision of failed fusion attempts o
o Pseudarthrosis
Spinal stenosis o

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

Device Description

The ISSYS LP Spinal Fixation System is comprised of a variety of pedicle screws, rods, cross connectors and staples sizes that may uniquely fitted for each individual case. All implants are manufactured from medical grade titanium alloy (Ti6A14V-ELI).

AI/ML Overview

The provided 510(k) summary for the ISSYS LP Spinal Fixation System does not contain information about specific acceptance criteria or a detailed clinical study demonstrating device performance against such criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that instead of proving the device meets specific performance metrics through a new study, the manufacturer asserts that the new device is as safe and effective as existing, legally marketed devices.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study for ISSYS LP Spinal Fixation System

Given the nature of a 510(k) submission, particularly for a device like a spinal fixation system, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a predicate device. This often involves mechanical testing and assessment of material properties rather than clinical performance metrics in the same way an AI diagnostic device might have.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only mentions "pre-clinical testing" and "substantial equivalence." It does not list specific numerical acceptance criteria or performance metrics in a table.

Acceptance Criteria Category	Specific Criteria (Expected for this type of device based on general regulatory standards, but not explicitly stated in the provided text)	Reported Device Performance (as inferred from "Pre-clinical testing performed indicated that the ISSYS LP Spinal Fixation System is substantially equivalent to predicate devices.")
Mechanical Strength & Durability	(e.g., Fatigue Strength, Static Bending Strength, Torsional Strength, Pull-out Strength; often tested to ISO or ASTM standards)	Demonstrated to meet the performance characteristics of predicate devices, implicitly indicating it withstands anticipated physiological loads and provides appropriate stability. The specific quantitative results are not provided but are assumed to be "equivalent" to predicate devices.
Material Biocompatibility	(e.g., Biocompatibility as per ISO 10993 for medical devices; no adverse tissue reaction, cytotoxicity, sensitization, etc.)	Manufactured from medical grade titanium alloy (Ti6Al4V-ELI), a commonly accepted biocompatible material for implants. Implied to be substantially equivalent to predicate devices in terms of material safety.
Design Characteristics	(e.e.g., Rod diameter, screw dimensions, thread design, locking mechanisms)	"The ISSYS LP Spinal Fixation System is comprised of a variety of pedicle screws, rods, cross connectors and staples sizes that may uniquely fitted for each individual case." "has the same indications for use, design, function, and materials used [as predicate devices]."
Indications for Use Alignment	The new device's intended use should align with, or be a subset of, the predicate device's indications.	Explicitly states: "ISSYS LP Spinal Fixation System was shown to be substantially equivalent to previously cleared devices and has the same indications for use..."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of a clinical test set from the provided document. The "tests" were pre-clinical (likely mechanical and material characterization). The sample size for these pre-clinical tests (e.g., number of screws tested for fatigue) is not mentioned.
Data Provenance: Not applicable for clinical data. For pre-clinical data, it would typically be internal laboratory testing or testing by a contract research organization. No specific origin is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a surgical implant, and the assessment is based on physical and mechanical properties, not expert interpretation of diagnostic images or clinical assessments for "ground truth."

4. Adjudication method for the test set

Not applicable. As described in point 3.

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

Not applicable. This is not an AI/diagnostic device.

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

Not applicable. This is not an algorithm or diagnostic device.

7. The type of ground truth used

For a device like this, "ground truth" relates to validated engineering specifications, material standards (e.g., ASTM F136 for Ti6Al4V-ELI, ISO 10993 for biocompatibility), and performance benchmarks established by predicate devices. No external "ground truth" (like pathology or outcomes data) for clinical performance is mentioned as part of this 510(k) submission's evidence for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning device, so there is no "training set."

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

Not applicable. As described in point 8.

Summary

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Custom Spine, Inc.

K070281

510(k) Summary according to 807.92(c)

JUN 1 1 2007

Company Contact:	Aaron MarkworthCustom Spine322 US Highway 46WSuite 270EParsippany, NJ 07054Phone: 973-808-0019Fax: 973-808-0707
Trade Name:	ISSYS LP Spinal Fixation System
Classification:	21 CFR §888.3070 - Pedicle Screw Spinal SystemAnd, §888.3050 Spinal Interlaminal Fixation Orthosis
Class:	III
Product Codes:	MNI, MNH, KWP, NKB

Indications For Use:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis), In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

· Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
o Spondylolisthesis

Confidential

pg 1 of 2

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Custom Spine, Inc.

K070281

દિવે

Fracture o
Spinal deformities such as scoliosis, kyphosis, lordosis o
o Tumor
Revision of failed fusion attempts o
o Pseudarthrosis
Spinal stenosis o

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

Device Description:

Predicate Device(s):

ISSYS LP Spinal Fixation System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.

Performance Testing:

Pre-clinical testing performed indicated that the ISSYS LP Spinal Fixation System is substantially equivalent to predicate devices.

Confidential

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Custom Spine % Richard Jansen, Pharm. D. Silver Pine Consulting 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K070281

Trade/Device Name: ISSYS LP Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH Dated: May 22, 2007 Received: May 23, 2007

JUN 1 1 2007

Dear Dr. Jansen:

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.

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

{3}------------------------------------------------

Page 2 - Richard Jansen, Pharm. D.

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 general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

for

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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Indications for Use

510(k) Number (if known): K670281

Indications for Use:

The ISSYS LP Spinal Fixation System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with 0 degeneration of the disc confirmed by history and radiographic studies).
Spondylolisthesis O
Fracture 0
Spinal deformities such as scoliosis, kyphosis, lordosis 0
Tumor 0
Revision of failed fusion attempts 0
Pseudarthrosis ට
Spinal stenosis 0

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nol

Division of and Neurological De

510(k) Number 4070281

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.