The Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola ¼" Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.

Device Description

The components of the Kaneda SR Anterior Spinal System consist of spinal plates, anterior vertebral body screws, transverse rod couplers and rods. This system can also be used in conjunction with some components of the Isola Spine System. Specifically, 1) the Isola ¼" rods 2) the Isola Open Caps and 3) the Isola Set Screws. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods. The screws are available in open and closed formats designed to fit the 1/4" rod in cancellous lengths of 35 mm to 60 mm. The Kaneda Anterior Spinal System utilizes the 1/4" diameter rod, available in 18" lengths or in precut lengths from 45 mm to 150 mm.

AI/ML Overview

The provided text pertains to the 510(k) summary for the AcroMed Kaneda SR Anterior Spinal System, a medical device. This document describes the device, its intended use, and its substantial equivalence to previously cleared devices. It also includes the FDA's clearance letter with specific conditions.

However, the provided text does not contain information regarding detailed acceptance criteria for device performance, nor does it describe a specific study (like a clinical trial or performance study with metrics such as sensitivity, specificity, or F1 score) that proves the device meets such criteria.

The "PERFORMANCE DATA" section states: "Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components." This is a very high-level statement and does not provide:

A table of acceptance criteria and the reported device performance.
Sample sizes used for a test set or data provenance. The testing mentioned is mechanical ("static and fatigue").
Number of experts used to establish ground truth or their qualifications. This is not applicable to mechanical testing of physical implants.
Adjudication method. Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable, as this is a physical medical device (spinal implant), not an AI/software device that assists human readers.
Standalone performance. The device is a physical implant; its "performance" is mechanical strength and durability, not an algorithm's output.
Type of ground truth used. For mechanical testing, this would typically be engineering specifications and standards, not expert consensus or pathology in a clinical sense.
Sample size for the training set. Not applicable for mechanical testing.
How ground truth for the training set was established. Not applicable for mechanical testing.

Conclusion based on the provided text:

The provided document (K971248 510(k) Summary) states that "Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components." This implies that the device met certain mechanical performance standards, which are usually defined by industry standards (e.g., ASTM) or internal specifications of the manufacturer, and these standards would constitute the "acceptance criteria" for such a physical implant. However, the exact numerical acceptance criteria, the specific test results, the sample sizes of the tested components, or the detailed methodology of these tests are not disclosed in the provided 510(k) summary. These details would typically be found in the full 510(k) submission, not the summary intended for public release.

Therefore, I cannot populate the requested table or answer the specific questions related to clinical performance, expert ground truth, or AI/software evaluation, as the provided text only refers to mechanical testing for a physical spinal implant.

Summary

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K971248

June 11, 1997 AcroMed Kaneda Anterior Spinal System 510(k) SUMMARY

COMPANY:	AcroMed Corporation3303 Carnegie AvenueCleveland, OH 44115
TRADENAME:	Kaneda SR Anterior Spinal System
CLASSIFICATION:	Spinal Intervertebral Body Fixation OrthosisClass II
DESCRIPTION:	The components of the Kaneda SR Anterior Spinal System consistof spinal plates, anterior vertebral body screws, transverse rodcouplers and rods. This system can also be used in conjunction withsome components of the Isola Spine System. Specifically, 1) theIsola ¼" rods 2) the Isola Open Caps and 3) the Isola Set Screws.The contoured spiked plates are designed to help the constructanchors resist axial forces and serve as a guide for placement of thescrews. The plates are available in three sizes (small, medium andlarge) and are designed as pairs with specific caudal and rostralcomponents. The screws serve to anchor the vertebral bodies to thelongitudinal rods. The screws are available in open and closedformats designed to fit the 1/4" rod in cancellous lengths of 35 mmto 60 mm. The Kaneda Anterior Spinal System utilizes the 1/4"diameter rod, available in 18" lengths or in precut lengths from 45mm to 150 mm.
MATERIAL:	The components of the Kaneda SR Anterior Spine System aremanufactured from titanium alloy conforming to ASTM F 136specifications.

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The Kaneda SR Anterior Spinal System is intended for anterolateral INDICATIONS: screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis), tumor, fracture and revision of previous surgery.

PERFORMANCE DATA:

Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components.

SUBSTANTIAL EQUIVALENCE:

The Kaneda SR Anterior Spinal System is substantially equivalent to the Kaneda Anterior Spinal Instrumentation as cleared under K873826, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN || 1997

Mr. William Christianson "Vice President, Requlatory Affairs and Quality Assurance AcroMed® 3303 Carnegie Avenue Cleveland, Ohio 44115

Re : K971248 Kaneda SR Anterior Spinal System Requlatory Class: II Product Code: KWQ Dated: April 2, 1997 Received: April 3, 1997

Dear Mr. Christianson:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act). to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.

FDA identifies that any device system, it intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the

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Page 2 - Mr. William Christianson

package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and

Pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a siqnificant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

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Page 3 - Mr. William Christianson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.

-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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K971248 510(k) Number (if known):

Kaneda SR Anterior Spinal System Device Name:

Indications for Use:

系

(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

Prescription Use (per 21 CRF 801.109)	X	OR	Over-The Counter Use
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510(k) Number	K971248
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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.