When intended for pedicle screw fixation from L1-S1, the indications include 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 lumbar and sacral spine: 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, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

Device Description

InSight constructs consist of bone screws, lock screws, connectors, swivels, and rods, which when assembled create a polyaxial range of motion. InSight only allows the placement of 5.5 mm titanium rods. InSight screws may be implanted in an open manner; or via cannulation, which allows a subset of procedures to be completed through a mini open procedure.

AI/ML Overview

The provided text describes the "Spinal Concepts, Inc. InSight™ Pedicle Screw System" and details its indications for use and mechanical testing. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device.

The document is a 510(k) summary for a medical device (spinal pedicle screw system), which is a physical implant, not a software device. Therefore, the concepts you've asked about (AI/ML device performance, test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not relevant to this type of submission and are not present in the text.

The text does mention "Mechanical testing data, including data collected in accordance with ASTM 1717 and ASTM 1798, was collected to verify that the design changes met established design requirements." These design requirements would serve as the "acceptance criteria" for this mechanical device, and the ASTM testing would be the "study" proving it. However, specific values for these criteria and reported performance are not detailed in this summary.

Therefore, I cannot provide the requested information based on the given input, as it pertains to a different type of medical device evaluation.

Summary

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K 631855

Spinal Concepts, Inc. InSight™ Pedicle Screw System

142

510(k) Summary of Safety and Effectiveness

SUBMITTED BY	Spinal Concepts, Inc.5301 Riata Park Court, Bldg. FAustin, TX 78727
ESTABLISHMENTREGISTRATION NUMBER	1649384
CONTACT PERSON	PrimaryAlternateLisa PetersonRegulatory Affairs SpecialistPhone: 512-533-1080Fax: 512-249-6734David Hooper, Ph.D.Director, Clinical andRegulatory AffairsPhone: 512-533-1038Fax: 512-249-6734	Primary	Alternate	Lisa PetersonRegulatory Affairs SpecialistPhone: 512-533-1080Fax: 512-249-6734	David Hooper, Ph.D.Director, Clinical andRegulatory AffairsPhone: 512-533-1038Fax: 512-249-6734
Primary	Alternate
Lisa PetersonRegulatory Affairs SpecialistPhone: 512-533-1080Fax: 512-249-6734	David Hooper, Ph.D.Director, Clinical andRegulatory AffairsPhone: 512-533-1038Fax: 512-249-6734
DATE PREPARED	June 11, 2003
CLASSIFICATION NAME	KWQ 888.3060- Spinal Intervertebral Body FixationOrthosisKWP 888.3050- Spinal Interlaminal Fixation OrthosisMNI 888.3070- Pedicle Screw Spinal SystemMNH 888.3070 - Spondylolisthesis Spinal Fixation SystemNKB 888.3070 - Pedicle Screw Fixation System,Degenerative Disc Disease
COMMON NAME	Spinal Fixation System
PROPRIETARY NAME	Spinal Concepts Inc. InSight ™ Pedicle Screw System
SUBSTANTIALEQUIVALENCE	The Spinal Concepts Inc. InSight Pedicle Screw Systemwas determined to be substantially equivalent to severalcommercially available systems.

DEVICE DESCRIPTION

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INDICATIONS:

MECHANICAL TEST DATA

Mechanical testing data, including data collected in accordance with ASTM 1717 and ASTM 1798, was collected to verify that the design changes met established design requirements.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines, suggesting movement and freedom. The logo is encircled by text, though the specific words are illegible due to the image quality. The overall design is simple and iconic, likely representing an organization or company.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2003

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts, Inc. 5301 Riata Park Court, Bldg. F Austin, TX 78727

Re: K031855 Trade/Device Name: InSight™ Pedicle Screw System Regulation Numbers: 21 CFR 888.3060, 888.3070, 888.3050 Regulation Names: Spinal intervertebral body fixation orthosis. Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: III Product Codes: KWQ, MNI, MNH, KWP, NKB Dated: June 11, 2003

Dear Ms. Peterson:

Received: June 24, 2003

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.

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Page 2 - Ms. Lisa Peterson

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 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 (301) 594-4659. 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mach N Melleman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ku 31852

INDIC ATIONS FOR USE STATEMENT

Page I of I

510(k) Number (if known):

Device Name:

Spinal Concepts, Inc. InSightTM Pedicle Screw System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR Over-The-Counter: __
(Optional Format 1-2-96)
for Mark N. Millem
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K031853

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.