The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) 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-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.

Device Description

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (pedicle screw system), not an AI/software as a medical device (SaMD). Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, etc.) are not applicable to this type of submission.

This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through mechanical performance testing for new components.

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this specific 510(k) submission are based on demonstrating that the new components for the CapSure® PS System perform at least as well as the predicate device, specifically in terms of mechanical stability and durability.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured by Physical Testing)	Reported Device Performance (Summary)
Static Axial Compression Bending	Performed according to ASTM F1717. (Implied: Demonstrated performance substantially equivalent to predicate).
Dynamic Axial Compression Bending	Performed according to ASTM F1717. (Implied: Demonstrated performance substantially equivalent to predicate).
Static Torsion Testing	Performed according to ASTM F1717. (Implied: Demonstrated performance substantially equivalent to predicate).
Overall Safety and Effectiveness	"Does not present any new issues of safety or effectiveness" compared to the predicate device.
Conformity to Indications for Use	The device (with new components) is suitable for the stated indications. (Implied: Confirmed through comparison).

Explanation: For a mechanical device like a pedicle screw system, "performance" is primarily measured by its physical properties and mechanical integrity under simulated physiological loads. The standard ASTM F1717 is a recognized standard for testing spinal implant constructs. The "reported performance" is that these tests were conducted and the results demonstrated substantial equivalence.

Study Details (as applicable to a mechanical device 510(k))

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as "test set" in the context of an algorithm. For mechanical testing, the "sample size" would refer to the number of device components or constructs tested for each configuration. Specific numbers are not provided in this summary, but these tests are typically conducted on multiple samples per configuration to ensure statistical validity (e.g., n=3 or n=6 per test).
Data Provenance: The testing was conducted internally or by a contract lab on physical components of the CapSure® PS System. This is a prospective experimental study (i.e., new tests were run on the new components) rather than a retrospective analysis of patient data. There is no "country of origin of the data" in the sense of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. "Ground truth" in the context of AI/SaMD (expert consensus, pathology, etc.) is not relevant for the mechanical testing of a pedicle screw system. The "truth" is established by the physical laws and mechanical properties measured in the laboratory according to established ASTM standards. The experts involved would be engineers/scientists designing and conducting the tests and analyzing the mechanical data.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication (e.g., 2+1, 3+1) is a method for resolving discrepancies in expert labeling or diagnoses for ground truth establishment in clinical data. This is not performed for mechanical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is specifically for evaluating the impact of AI on human readers' performance (e.g., radiologists interpreting images). It is not relevant for a physical medical device like a pedicle screw system.

6. Standalone (Algorithm Only) Performance

Not Applicable. There is no algorithm or software being evaluated for standalone performance in this submission.

7. Type of Ground Truth Used

Engineering/Mechanical Standards and Measurements: The "ground truth" for this device is its physical performance and integrity as measured against established industry standards (ASTM F1717) and compared to the known safe and effective performance of its predicate device. This is determined through controlled laboratory experiments.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of mechanical device testing. The device components themselves are the "subject" of the test, and their design is based on engineering principles and prior device knowledge, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there's no training set, there's no ground truth establishment for one. The design and testing methodologies are based on established engineering principles, material science, and regulatory requirements for medical devices.

Summary

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Kia2233

SpineWave

OCT | 1 | 2012

000033

510(k) Summary CapSure® PS System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise Drive
	Suite 210
	Shelton, CT 06484
Telephone:	203-712-1847
Telefax:	203-944-9493
Contact:	Joseph Mercado
Date Prepared:	July 25, 2012

2. Device Information

Trade Name:	CapSure® PS System
Common Name:	Pedicle Screw Spinal System
Classification Name:	Pedicle Screw Spinal System
Classification/Code:	Class II per 21 CFR 888.3070; MNI, MNH

3. Purpose of Submission

The purpose of this submission is to gain clearance for the addition of new optional titanium alloy connector components to the cleared CapSure® PS System.

4. Predicate Device Information

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

Predicate Device	Manufacturer	510(k) No.
CapSure® PS System	Spine Wave, Inc.	K120646

5. Device Description

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Klaa33

6. Intended Use

7. Comparison of Technological Characteristics

The substantial equivalence of the subject CapSure® PS System is shown by similarity in intended use, indications for use, materials and performance to the cited predicate device.

8. Performance Data

Static axial compression bending, dynamic axial compression bending, and static torsion testing according to ASTM F1717 were performed to demonstrate that the modified CapSure® PS System is substantially equivalent to the predicate CapSure® PS System.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to a predicate, the subject CapSure® PS System has been shown to be substantially equivalent to the predicate device identified in this submission, and does not present any new issues of safety or effectiveness.

Rs 20f 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

1 1 2012

Spine Wave, Incorporated
% Mr. Joseph Mercado
Regulatory Affairs Specialist
Three Enterprise Drive, Suite 210
Shelton, Connecticut 06484

Re: K122233

Trade/Device Name: CapSure® PS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: September 26, 2012 Received: September 27, 2012

Dear Mr. Mercado:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Joseph Mercado

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ernst Keith

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

Enclosure

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510(k) Number (if known):

CapSüre® PS System Device Name:

Indications for Use:

KI22233

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)

(Div/sion Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices

KI22233 510(k) Number_

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.