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

This document describes a 510(k) premarket notification for a medical device called the CapSure® PS System, a pedicle screw spinal system. The submission seeks clearance for additional components to an already cleared system. As such, the information provided focuses on the substantial equivalence to a predicate device rather than on novel acceptance criteria and a detailed clinical study demonstrating performance against those criteria as would be required for a de novo submission or a new device with significant technological differences.

Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as detailed study information often associated with AI/software devices, cannot be fully generated. This document pertains to a hardware medical device (pedicle screw system), and therefore, the type of "acceptance criteria" and "study" are different from what one might expect for a software or AI-based device.

However, I can extract the available information related to performance data and the rationale for claiming substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from testing)	Reported Device Performance / Rationale
Mechanical Performance	Static Compression	"The modified implants were compared to constructs previously tested in static compression... in accordance with ASTM F1717."
	Static Torsion	"The modified implants were compared to constructs previously tested in... static torsion... in accordance with ASTM F1717."
	Dynamic Compression	"The modified implants were compared to constructs previously tested in... dynamic compression in accordance with ASTM F1717."
Safety and Effectiveness	Substantial Equivalence	"An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to be substantially equivalent to the predicate devices."
	No new issues of safety or effectiveness	"Based on the indications for use, technological characteristics and comparison to a predicate, the subject CapSure® PS System... does not present any new issues of safety or effectiveness."

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

Sample Size: The document does not specify a "sample size" in terms of human subjects or a large dataset often associated with AI/software studies. Instead, it refers to "modified implants" and "constructs previously tested." This implies an engineering test setup with a limited number of physical components for mechanical testing. No specific number is given.
Data Provenance: Not applicable in the context of clinical data or country of origin. The data provenance is from mechanical testing conducted in accordance with ASTM F1717. The document does not specify where these tests were performed, but given the manufacturer is US-based and seeking FDA clearance, it's presumed to be from a reputable testing facility, likely within the US, or a recognized international body. The tests are "retrospective" in the sense that the modified implants are compared to "constructs previously tested" rather than new testing being exclusively performed for the new components (though some testing was likely done to ensure the comparison is valid).

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

Not Applicable. This is a hardware medical device; the "ground truth" is established by adherence to recognized mechanical testing standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes in the same way an AI device would. The "experts" involved would be mechanical engineers and test technicians responsible for performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

Not Applicable. As this is mechanical testing of hardware, there is no expert adjudication process in the manner of multiple medical professionals independently reviewing cases and reaching a consensus. The "adjudication" is based on whether the devices meet the specified parameters of the ASTM F1717 standard and if the engineering rationale for substantial equivalence is sound.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the performance of AI/software in a clinical context (e.g., how AI assistance impacts human readers' diagnostic accuracy). This document pertains to a physical implantable device, so an MRMC study was not conducted or required for this type of submission.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This is a hardware device. There is no standalone algorithm to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is the mechanical test results obtained by following recognized industry standards (ASTM F1717) for spinal implant performance, alongside an engineering rationale demonstrating that the updated components do not negatively impact these established performance characteristics and are equivalent to the predicate.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. There is no training set for this hardware device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white and appears to be a scanned image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 9, 2013

Mr. Joseph Mercado Regulatory Affairs Specialist Spine Wave. Incorporated 3 Enterprise Drive. Suite 210 Shelton. Connecticut 06484

Re: K132154

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: July 11, 2013 Received: July 12, 2013

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warnanties. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/SafetyReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith

For

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

Enclosure

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510(k) Number (if known): _K132154

CapSure PS System Device Name: _

Indications for Use:

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, 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 LS-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.

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

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

AND/OR

Concurrence of CDRH. Office of Device Evaluation (ODE)

Amy S. Graf -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132154

Page _ 1_ of _1

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SPINE WAVE

510(k) Summary CapSure® PS System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1847
Telefax:	203-944-9493

Contact: Joseph Mercado

Date Prepared: July 11, 2013

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 additional 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.	K122233

5. Device Description

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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

The modified implants were compared to constructs previously tested in static compression, static torsion and dynamic compression in accordance with ASTM F1717. An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to the substantially equivalent to the predicate devices.

9. Conclusion

Based on the indications for use, technological characteristics 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.

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.