The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.

Device Description

The Vista -S Device is a box-shaped vertebral body replacement fabricated from polyetheretherketone (PEEK) that is designed to accommodate the partial replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.

AI/ML Overview

The provided text is a 510(k) summary for the Vista®-S Device, a vertebral body replacement device. This type of regulatory submission in the medical device industry does not typically involve the kind of "acceptance criteria" and "device performance study" as would be found in an AI/software device submission.

Instead, a 510(k) demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. The studies conducted for such devices are typically focused on bench testing (e.g., mechanical strength, fatigue), biocompatibility, and sometimes limited animal studies, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of medical device and the information provided in the 510(k) summary.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

Not Applicable in the traditional sense for this device type.
For a spinal implant like the Vista®-S Device, "acceptance criteria" would typically relate to mechanical properties (e.g., compressive strength, fatigue life, subsidence resistance), biocompatibility, and sterilization effectiveness. The 510(k) summary does not detail specific acceptance criteria or quantitative performance data from such tests.
Instead, the submission focuses on substantial equivalence to predicate devices in terms of materials, technological characteristics, and basic principles of operation. The "performance" is implicitly deemed acceptable if it meets the safety and effectiveness standards of the predicate.

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

Not Applicable.
No clinical "test set" in the context of diagnostic accuracy or AI performance is mentioned. The studies conducted would be non-clinical (mechanical, biological). The document does not specify sample sizes for these non-clinical tests.

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

Not Applicable.
There is no "ground truth" to establish for a test set in this context. The evaluation is on the device's physical properties and comparison to existing technology, not on interpretations by experts.

4. Adjudication method for the test set

Not Applicable.
No clinical test set requiring adjudication is mentioned.

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 device is a physical implant, not an AI or diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not Applicable.
This is not an algorithm or AI device.

7. The type of ground truth used

Not Applicable in the traditional sense.
For this type of device, "ground truth" would be established by validated engineering standards, material specifications, and regulatory guidelines for mechanical testing and biocompatibility. The summary does not elaborate on these details.

8. The sample size for the training set

Not Applicable.
There is no "training set" for this physical device.

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

Not Applicable.
No training set is involved.

Summary of what is known from the provided text:

Device Name: Vista®-S Device
Device Type: Vertebral Body Replacement Device (spinal implant)
Intended Use: Partial replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) due to tumor or trauma (e.g., fracture). Intended for use with supplemental internal spinal fixation systems and may be used with bone graft.
Regulatory Pathway: 510(k) Premarket Notification, demonstrating "substantial equivalence" to predicate devices.
Basis for Acceptance: The FDA determined the device is substantially equivalent to legally marketed predicate devices with respect to intended use/indications for use, materials, technological characteristics, and basic principles of operation. This means the device is deemed as safe and effective as existing devices without requiring new clinical performance studies of the type typical for AI or diagnostic devices.
Classification: Class II, product code MQP (Spinal intervertebral body fixation orthosis).

The provided text focuses on the regulatory submission process and the classification of the device rather than detailed performance studies or AI validation.

Summary

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K070382

510(k) Summary

MAY 3 0 2007

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Jennifer P. HarakalSenior Specialist, Regulatory AffairsTelephone: (973) 576-0133Fax: (973) 884-8795
Date:	April 25, 2007
Trade Name:	Vista®-S Device
Common Name:	Vertebral Body Replacement Device
Classification Name andReference:	Spinal Intervertebral Body Fixation Orthosis21 CFR § 888.3060, MQP

DEVICE DESCRIPTION

INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE

Documentation was provided which demonstrated that the Vista -S Device is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer Trabecular Metal Technology, Inc. % Ms. Jennifer P. Harakal Senior Specialist, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054

MAY 3 0 2007

Re: K070382

Trade Name: Vista®-S Device Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Codes: MOP Dated: February 6, 2007 Received: February 8, 2007

Dear Ms. Harakal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described 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.

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. This letter will allow you to begin marketing your device as described in your 510(k) premarket

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Page 2 -- Ms. Harakal

notification. The 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), 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). Other general information on your responsibilities under the Act may be obtained 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. Mcl Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _

Device Name: Vista®-S Device

Indications for Use:

Prescription Use_ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off (Division Signeral, Restorative, Division of Neurological Devices

510(k) Number L090382

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.