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 CapSure® PS System consists of a selection of non-sterile, single use, titanium allov polyaxial screw and connector components, and titanium alloy and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The 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 document is a 510(k) premarket notification for a medical device called the "CapSure® PS System," which is a Pedicle Screw Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through a clinical study that would have acceptance criteria for performance metrics like sensitivity or specificity.

Therefore, many of the requested elements for a study proving device performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and training set ground truth establishment) are not applicable to this type of device submission.

Instead, the acceptance criteria and proof of performance for this device are based on mechanical testing to demonstrate that the new components for the CapSure® PS System are substantially equivalent to the previously cleared predicate CapSure® PS System components and other predicate pedicle screw systems.

Here's the information that is applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Method	Reported Device Performance
Mechanical Performance	Mechanical testing according to ASTM F1717, including:	The subject CapSure® PS System demonstrated substantial equivalence to the predicate CapSure® PS System.
	- Static compression bending	Passing results (implicit by substantial equivalence claim)
	- Dynamic compression bending	Passing results (implicit by substantial equivalence claim)
	- Static torsion	Passing results (implicit by substantial equivalence claim)
Material Equivalence	Materials: Titanium alloy, cobalt chrome alloy	Equivalent to predicate devices (implicit by substantial equivalence claim)
Intended Use & Indications for Use Equivalence	Intended use and indications for use are similar to predicate devices.	The updated CapSure® PS System maintains substantial equivalence in intended use and indications for use to its predicate devices, with modifications for new component additions.

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

Not applicable for a clinical study. For mechanical testing, the "sample size" would refer to the number of components tested according to ASTM F1717. This specific number is not provided in the 510(k) summary, but it would adhere to the sample size requirements of the ASTM F1717 standard itself.
Data Provenance: The data comes from internal mechanical testing performed by Spine Wave, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth in the context of clinical interpretation by experts is not relevant here as this is a mechanical device, not a diagnostic or AI device. The "ground truth" for mechanical testing is adherence to the specified ASTM standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept relates to expert review of clinical cases. For mechanical testing, adherence to the ASTM standard is directly measurable.

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 a mechanical spinal fixation system, not an AI-assisted diagnostic device.

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

Not applicable. This refers to AI algorithms, which is not relevant to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For mechanical testing, the "ground truth" is adherence to established engineering standards and specifications (ASTM F1717) and demonstrating performance equivalent to the predicate devices.

8. The sample size for the training set:

Not applicable. This refers to AI training data.

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

Not applicable. This refers to AI training data.

Summary

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K120644

JUN - 7 2012

SPINE WAVE

510(k) Summary CapSure® PS System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1839
Telefax:	203-944-9493
Contact:	Roaida Rizkallah
Date Prepared:	June 4, 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 / MNH, MNI

3. Purpose of Submission

The purpose of this submission is to gain clearance for additional components for the CapSure® PS System, including hex-end titanium alloy and cobalt chrome alloy rods, additional screw sizes, and offset connectors. The indications for use is also being modified as a result of these line additions.

4. Predicate Device Information

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

Predicate Device	Manufacturer	510(k) No.
CapSure® PS System	Spine Wave, Inc.	K070245, K081228,
		K083353, K083743,
		K100122, and K111913
XIA® 3 System	Stryker Spine	K083393
USS System	Synthes	K111358

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K120646

5. Device Description

6. Intended 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 turnor, and failed previous fusion (pseudoarthrosis).

7. Comparison of Technological Characteristics

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

8. Performance Data

Mechanical testing according to ASTM F1717, including static and dynamic compression bending and static torsion, were performed to demonstrate that the subject 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 the predicates, the subject CapSure® PS System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness

Pg 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

JUN - 7- 2012

Spine Wave, Inc. % Ms. Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K120646

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: May 14, 2012 Received: May 15, 2012

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, 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

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Page 2 – Ms. Roaida Rizkallah

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 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

cerely yours.

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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KIZOGGG

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _

CapSure® PS System

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K120646 510(k) Number

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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.