When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

Device Description

The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

AI/ML Overview

The provided text describes a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a study evaluating the performance of a device against specific acceptance criteria.

The information typically found in a study demonstrating device performance against acceptance criteria (such as detailed performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment) is not present in this type of regulatory submission. The 510(k) pathway focuses on establishing that a new device is as safe and effective as another legally marketed device (the predicate device) through comparison, often including mechanical testing for physical equivalence.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document states:

Substantial equivalence: The CapSure® PS System is substantially equivalent to the predicate device, CapSure® PS System (K081228), manufactured by Spine Wave, Inc.
Proof of equivalence: "mechanical testing demonstrated that the CapSure® PS System is equivalent to its predicate device. The minor differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness."

This indicates that the "study" demonstrating the device meets approval criteria was primarily a mechanical testing study comparing it to the predicate device. However, no specific quantitative acceptance criteria or detailed performance results from this testing are provided in the summary.

Here's why the requested information is absent and what can be inferred:

Table of acceptance criteria and reported device performance: Not provided. The 510(k) summary asserts "equivalence" based on mechanical testing without detailing the specific criteria or results.
Sample size used for the test set and data provenance: Not applicable in the context of a 510(k) summary focused on mechanical equivalence. "Test set" here refers to mechanical samples, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Mechanical testing typically involves engineers and standardized testing protocols, not medical experts establishing ground truth for diagnostic accuracy.
Adjudication method for the test set: Not applicable for mechanical testing for 510(k) equivalence.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with AI and is not relevant for a spinal implant's mechanical equivalence.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a physical implant, not an algorithm.
Type of ground truth used: For mechanical testing, the "ground truth" would be established by industry standards (e.g., ASTM standards) and the performance of the predicate device under those standards.
Sample size for the training set: Not applicable (no algorithmic training involved).
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

SPINE WAVE

K083353

DEC 11 2008

510(k) Summary CapSure® PS System

Submitter Information

Spine Wave. Inc. Two Enterprise Drive Suite 302 Shelton, CT 06484 Telephone: 203-712-1839 203-944-9493 Telefax:

Contact: Date Prepared:

Roaida Rizkallah November 12, 2008

Device Information

Trade name: Common name: Classification: Product Code:

CapSure® PS System Pedicle Screw Spinal System Class II per 21 CFR 888.3070 Classification Name: Pedicle Screw Spinal System MNI, MNH

Device Description

Intended Use

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

Substantial equivalence

The CapSure® PS System described in this submission is substantially equivalent to the following device:

Predicate Device	Manufacturer1	510(k) No.
CapSure® PS System	1 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8Spine Wave, Inc.	K081228

In addition, mechanical testing demonstrated that the CapSure® PS System is equivalent to its predicate device. The minor differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the CapSure® PS System is substantially equivalent to its predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine Wave, Inc. % Ms. Roaida Rizkallah Regulatory Affairs Specialist Two Enterprise Drive, Suite 202 202 Shelton, Connecticut 06484

Re: K083353

Trade/Device Name: CapSure® PS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: November 12, 2008 Received: November 13, 2008

DEC 1 1 2008

Dear Ms. Rizkallah:

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. Iisting 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.

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

Page 2 - Ms. Roaida Rizkallah

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark N. Mikkelson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): _ Ko 8 3363

CapSure® PS System Device Name:

Indications for Use:

Prescription Use (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)

Dohre

(Division Sign-Off (Division Sign-Onal, Restorative, and Neurological

510(k) Number

Page 1 of 1

Regulation Number and Section

N/A