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 thoracic, 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

PathFinder is a modification to the existing Spinal Concepts Inc. InCompass polyaxial screw design. The design modification allows the components to be implanted through an open or mini open surgical technique. The mini-open surgical technique is conducted using k-wires and cannulated PathFinder screws.

AI/ML Overview

The information provided is for the Spinal Concepts, Inc. PathFinder, which is a medical device (spinal fixation system) and not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance (like those requested in the prompt regarding sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets, etc.) is not applicable here.

The provided document describes a 510(k) submission for a design modification of an existing spinal fixation system. The assessment for such a device focuses on mechanical testing, biocompatibility, and substantial equivalence to a predicate device, rather than AI/ML performance metrics.

Specifically, the document states:

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."

This indicates that the device's acceptance criteria are related to its mechanical performance and safety, as demonstrated through compliance with specific ASTM standards. The study mentioned is a series of mechanical tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of AI/ML metrics, nor can I answer questions about sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies, as these concepts do not apply to this type of device and the information provided.

Summary

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K030625 p1/2

Spinal Concepts, Inc. PathFinder

MAR 2 8 2003

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 PetersonDavid Hooper, Ph.D.Regulatory Affairs SpecialistDirector, Clinical and Regulatory AffairsPhone: 512-918-2700Phone: 512-918-2700Fax: 512-249-6734Fax: 512-249-6734		Primary	Alternate	Lisa Peterson	David Hooper, Ph.D.	Regulatory Affairs Specialist	Director, Clinical and Regulatory Affairs	Phone: 512-918-2700	Phone: 512-918-2700	Fax: 512-249-6734	Fax: 512-249-6734
	Primary	Alternate
	Lisa Peterson	David Hooper, Ph.D.
	Regulatory Affairs Specialist	Director, Clinical and Regulatory Affairs
	Phone: 512-918-2700	Phone: 512-918-2700
	Fax: 512-249-6734	Fax: 512-249-6734
DATE PREPARED	March 17, 2003
CLASSIFICATION NAME	MNI 888.3070- Pedicle Screw Spinal SystemMNH 888.3070 – Spondylolisthesis Spinal FixationSystemNKB 888.3070 - Pedicle Screw Fixation System,Degenerative Disc Disease
COMMON NAME	Spinal Fixation System
PROPRIETARY NAME	Spinal Concepts Inc. PathFinder
PREDICATE DEVICE	Spinal Concepts Inc. InCompass Spinal FixationSystem (K021564 and K023644). This is a designmodification per established design controlprocedures.

DEVICE DESCRIPTION

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INDICATIONS:

PathFinder - Mini-Open Posterior Approach

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. 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

MAR 2 8 2003

Ms. Lisa Peterson Regulatory Affairs Specialists Spinal Concepts, Inc. 12012 Technology Blvd. Suite 100 Austin, Texas 78727

Re: K030625 Trade/Device Name: Pathfinder Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Fixation System Regulatory Class: III Product Code: NKB, MNI, MNH Dated: February 24, 2003 Received: February 27, 2003

Dear Ms. Peterson:

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 (OS) 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) 594-4639. 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,

Mark N. Millikan

Colin M. Wittwer, 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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510(k) Number (if known):

Device Name:

Spinal Concepts, Inc. PathFinder (Adjunct to InCompass Spinal Fixation System)

Indications for Use:

PathFinder - Mini-Open Posterior Approach

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.

Mark N. Melkers

(Division Sign-Of (Division of General. Restorative and Neurological Devices

510(k) Number -

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(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)

Mark N Millkan

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K030625

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.