The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures.

The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are:

Idiopathic scoliosis.
Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
Neuromuscular scoliosis/kyphoscoliosis.
Spinal fractures (acute reduction or late deformity).
Revision surgery.
Tumor.

The FRONTIER Anterior Scoliosis System can also be 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. Indications for these scoliotic uses include:

Collapsing and unstable paralytic deformity.
Progressively increasing scoliosis.
Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
Inability to maintain sitting balance, necessitating the use of hands.
Increasing pelvic obliquity coincident with back pain or loss of sitting balance.

Device Description

The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spinal staples, and spinal washers. The implants of the FRONTIER Anterior Scoliosis System have been designed for use in either open or thoracoscopic approaches.

AI/ML Overview

The provided 510(k) summary for the FRONTIER Anterior Scoliosis System describes a medical device, which is a physical implant, not a software algorithm or AI device. Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of accuracy, sensitivity, specificity, MRMC studies, standalone performance, and ground truth establishment, are not applicable. These criteria are typically used for evaluating diagnostic software or AI-powered devices that produce an output or make a prediction.

This submission focuses on the mechanical and material equivalence of the FRONTIER Anterior Scoliosis System to predicate devices, and its intended use as a spinal fixation orthosis.

However, I can extract information related to the device description, intended use, and the regulatory process for this physical medical device.

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device (spinal implant) and not a software/AI device, acceptance criteria are generally related to mechanical properties, biocompatibility, and manufacturing quality, rather than performance metrics like sensitivity or AUC. The document states:

Acceptance Criteria (Implied): Substantial equivalence to predicate devices (MOSS MIAMI Spinal System (K953915), KANEDA™ Anterior Scoliosis System (K974757), CD HORIZON® ECLIPSE™ (K001066)) in terms of design, materials, and intended use. Performance data were "submitted to characterize the FRONTIER Anterior Scoliosis System."
Reported Device Performance: The document generally states "Performance data were submitted to characterize the FRONTIER Anterior Scoliosis System." However, specific numerical performance results (e.g., in vitro biomechanical test results, fatigue limits, etc.) are not included in this 510(k) summary. The 510(k) summary primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study involving human data or a test set in the context of an AI/software device. The performance data mentioned would likely refer to in-vitro mechanical testing and material characterization, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment with experts is relevant for diagnostic accuracy studies, not for the regulatory submission of a physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving diagnostic accuracy or human interpretation of data.

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 a spinal implant, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is a physical spinal implant, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. Ground truth is not a concept applied in this context for regulatory approval of a physical implant. Performance data would involve engineering specifications, material properties, and manufacturing standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. See point 8.

Summary

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$[K012916](https://510k.innolitics.com/search/K012916) p^\prime$

XIII. 510(k) Summary	NOV 2 7 2001
SUBMITTER:	DePuy AcroMed, Inc.325 Paramount DriveRaynham, MA 02780
CONTACT PERSON:	Lisa A. Gilman
DATE PREPARED:	August 22, 2001
CLASSIFICATION NAME:	Spinal Intervertebral Body Fixation Orthosis
PROPRIETARY NAME:	Frontier Anterior Scoliosis System
PREDICATE DEVICES:	MOSS MIAMI Spinal System (K953915)KANEDA™ Anterior Scoliosis System (K974757)CD HORIZON® ECLIPSE™ (K001066)
DESCRIPTION:	The FRONTIER Anterior Scoliosis System consists ofspinal rods, spinal screws, spinal staples, and spinalwashers. The implants of the FRONTIER AnteriorScoliosis System have been designed for use ineither open or thoracoscopic approaches.
INTENDED USE:	The FRONTIER Anterior Scoliosis System is intendedfor anterolateral screw fixation to the T4 to L4 levelsof the spine, with all metal at least 1 cm from a majorvessel. The FRONTIER Anterior Scoliosis Systemmay be used in either thoracoscopic procedures oropen procedures.The FRONTIER Anterior Scoliosis System is intendedto provide temporary stabilization as an adjunct tospinal bone grafting processes. Specific indicationsare:1. Idiopathic scoliosis.2. Degenerative disc disease (defined as discogenicback pain with degeneration of the disc confirmedby history and radiographic studies).3. Scoliosis with deficient posterior elements such asthat resulting from laminectomy ormyelomeningocele

{1}------------------------------------------------

1. Neuromuscular scoliosis/kyphoscoliosis.
reduction or late 5. Spinal fractures (acute deformity).
1. Revision surgery.
1. Tumor.

1. Collapsing and unstable paralytic deformity.
1. Progressively increasing scoliosis.
1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
1. Inability to maintain sitting balance, necessitating the use of hands.
1. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.

Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.

PERFORMANCE DATA:

Performance data were submitted to characterize the FRONTIER Anterior Scoliosis System.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 7 2001

Ms. Lisa Gilman Regulatory Affairs Associate DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K012916

Trade/Device Name: FRONTIER™ Anterior Scoliosis System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 29, 2001 Received: August 30, 2001

Dear Ms. Gilman:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the sured in the oneroune) to ical Device Amendments, or to devices that have been reclassified in enceentence 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 therefore, mailions 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 Marufacturing 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 mspotions, and 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.

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

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 noutication. The I Dri incing of basicin 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 and If you desire spoonly an in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in 10 for questions on the promotion and advertising of your device, (2017) 594-4639. 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 monifacturers 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,
Micheal N Milliken

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

{4}------------------------------------------------

Indications for Use IV.

K012916

012910 510(k) Number (if known): __

FRONTIER™ Anterior Scoliosis System Device Name:

Indications For Use:

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to The FRONTILITY Antenor Society with all metal at least 1 cm from a major vessel. The the 14 to L4 levels of the opino, wan may be used in either thoracoscopic procedures or open procedures.

The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are:

1. Idiopathic scoliosis.
1. Tulopatino Socillone.

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

1. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
1. Neuromuscular scoliosis/kyphoscoliosis.
1. Spinal fractures (acute reduction or late deformity).
1. Revision surgery.
1. Tumor.

The FRONTIER Anterior Scoliosis System can also be used for the correction and The TRONTIE. Antonor of scoliotic curves, for the prevention or recurrence of undesired scoliotic Stablization of Soollow Garroof, Yorks, Yorks. Indications for these scollotic uses include:

1. Collapsing and unstable paralytic deformity.
1. Progressively increasing scoliosis.
1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
1. Inability to maintain sitting balance, necessitating the use of hands.
1. Increasing pelvic obliquity coincident with back pain or Joss of sitting ba

back pain or loss of sitting balance.

Division Sign-Off)
Division of General, Restorative

(Division of General, Restorative and Neurological Devices

K012916

510(k) Number -

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use:_

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.