The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis, ●
trauma (i.e. fractures or dislocations), .
tumors, .
deformity (defined by kyphosis, lordosis, or scoliosis), .
pseudoarthrosis, and .
failed previous fusion. .

Device Description

The Altiva Classic ACP System is an anterior screw fixation system for the cervical spine. It includes titanium alloy plates and screws which are provided clean and non-sterile. Various sizes of the implants are provided.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided document (K070891) is a 510(k) Premarket Notification for the Altiva® Classic ACP System, a spinal intervertebral fixation orthosis. However, it is primarily a regulatory submission for substantial equivalence and does not contain detailed performance study data, acceptance criteria, or ground truth information in the way typically found for AI/software-as-a-medical-device (SaMD) clearances.

The document states: "Performance data were submitted to characterize the Altiva Classic ACP System." However, the details of these performance data, including specific acceptance criteria, study methodologies, sample sizes, and how ground truth was established, are not present within this summary document. 510(k) summaries often only state that performance data were submitted without detailing the results or methodology.

Therefore, I cannot fulfill all parts of your request based solely on the provided text, as much of the requested information (especially points 1-9 regarding a device's performance against detailed acceptance criteria and a study to prove it) is not included in this type of regulatory summary.

Here's what I can provide based on the given text, and where I must state that information is not available:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided 510(k) summary. This document focuses on the regulatory clearance for a physical orthopedic implant system, not a software-based diagnostic device with measurable performance metrics like sensitivity or specificity against a ground truth. The "performance data" mentioned would typically relate to mechanical testing (e.g., fatigue, static strength, torsion) to ensure the device's structural integrity and biocompatibility, not diagnostic accuracy in the way you've outlined.

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

Not available in the provided 510(k) summary. Given this is a physical implant, typical "test sets" would involve mechanical testing, not patient data in the context of diagnostic performance.

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

Not applicable/available. Ground truth as typically understood for diagnostic device performance (e.g., expert reads, pathology) is not relevant for the regulatory clearance of a physical orthopedic implant.

4. Adjudication method for the test set

Not applicable/available.

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/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

7. The type of ground truth used

Not applicable. For a physical implant, "ground truth" would relate to engineering specifications for material properties and mechanical performance. The document states "Performance data were submitted to characterize the Altiva Classic ACP System," indicating engineering tests were conducted, but the specifics of these tests (e.g., fatigue strength, pull-out force, torsion) and their acceptance criteria are not detailed in this summary.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

Summary of What Is Available in the Document:

Device Type: Spinal Intervertebral Fixation Orthosis (physical implant, screws and plates).
Intended Use: Anterior screw fixation to the cervical spine (C2 to C7) for temporary stabilization during developing fusion for various conditions (degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudoarthrosis, failed previous fusion).
Regulatory Clearance: 510(k) clearance based on substantial equivalence to a predicate device.
Performance Data: The summary states "Performance data were submitted to characterize the Altiva Classic ACP System." This implies mechanical, material, and biocompatibility testing appropriate for an implant, but the details are not included in this public summary.

To obtain the detailed performance data, acceptance criteria, and specific testing methodologies for this device, one would typically need to review the full 510(k) submission, which is often not publicly available in its entirety. The provided document is a summary for public notification of regulatory clearance.

Summary

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K070891

JUN 1 1 2007

PREMARKET NOTIFICATION 510(K) SUMMARY

Company:	Altiva Corporation9800 Suite i, Southern Pines BlvdCharlotte, NC 28273Telephone: 704/409-1754Fax: 704/409-1771
Company Contact:	John KapitanVice President, Product Development and RA/QA
Date:	March 27, 2007
Trade Name:	Altiva® Classic ACP System
Common Name	Spinal Intervertebral Fixation Orthosis
Classification:	Orthopedics, 888.3060, Class II
FDA Product Code :	KWQ
Device Description:	The Altiva Classic ACP System is an anterior screwfixation system for the cervical spine. It includestitanium alloy plates and screws which are providedclean and non-sterile. Various sizes of the implants areprovided.
Intended Use:	The Altiva Classic ACP System is intended for anteriorscrew fixation to the cervical spine (C2 to C7). Thesystem is intended for use in the temporary stabilizationof the anterior spine during the development of cervicalspinal fusion in patients with degenerative disc disease(as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient historyand radiographic studies), spondylolisthesis, trauma(i.e. fractures or dislocations), tumors, deformity(defined by kyphosis, lordosis, or scoliosis),pseudoarthrosis, and failed previous fusion.
Predicate Device:	Predicate device information is included.
Performance Data:	Performance data were submitted to characterize theAltiva Classic ACP System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing left. The eagle is composed of three curved lines that form the body, wings, and tail feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altiva Corporation % Mr. John Kapitan VP, Product Development, RA/QA 9800 Southern Pines Boulevard Charlotte, North Carolina 28273

JUN 1 1 2007

Re: K070891

Trade/Device Name: Altiva® Classic ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 26, 2007 Received: March 30, 2007

Dear Mr. Kapitan:

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 – Mr. John Kapitan

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 (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 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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Page 3 – Mr. John Kapitan

cc: HFZ-401 DMC IIFZ-401 DMC
HFZ-404 510(k) Staff HFZ- Division D.O. f/t:SJB:afb:6/4/07

OC Numbers:

Division of Enforcement A	240-276-0115
Dental, ENT and Ophthalmic Devices Branch	240-276-0115
OB/GYN, Gastro. & Urology Devices Branch	240-276-0115
General Hospital Devices Branch	240-276-0115
General Surgery Devices Branch	240-276-0115
Division of Enforcement B	240-276-0120
Cardiovascular & Neurological Devices Branch	240-276-0120
Orthopedic, Physical Medicine & Anesthesiology Devices Br	240-276-0120

and the comments of the comments of

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Indication for Use Statement

510(k) Number (if known): 长070891

Device Name: Altiva® Classic ACP System

Indications for Use:

degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis, ●
trauma (i.e. fractures or dislocations), .
tumors, .
deformity (defined by kyphosis, lordosis, or scoliosis), .
pseudoarthrosis, and .
failed previous fusion. .

Prescription Use × or

Over-The-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mok

Division of General, Restorative, and Neurological Devices

510(k) Number.

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.