The Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

Picasso MIS Spinal System consists of cannulated polyaxial screw, straight and curved rod, Cross-link and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.

AI/ML Overview

Acceptance Criteria and Study for Picasso MIS Spinal System

The Picasso MIS Spinal System is a medical device, specifically a pedicle screw spinal system, designed to provide immobilization and stabilization of spinal segments. For such devices, acceptance criteria are typically based on mechanical performance to ensure the device can withstand the physiological loads it will experience in the human body. The provided document details a study demonstrating the device's compliance with these mechanical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Standard	Reported Device Performance
Static Compression Bending	ASTM F1717	Performed as well as the predicate device
Tension	ASTM F1717	Performed as well as the predicate device
Dynamic Compression Bending	ASTM F1717	Performed as well as the predicate device

Note: The document states "Performed as well as the predicate device." This implies that the Picasso MIS Spinal System met or exceeded the established mechanical performance benchmarks derived from the predicate device under these specific ASTM F1717 tests. The exact numerical values for these benchmarks and the device's performance are not provided in this summary.

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

The study described is a mechanical performance study, not a clinical study involving human or biological samples. Therefore, the concept of "sample size used for the test set" typically refers to the number of device constructs tested. The document specifies that the tests were performed "on a worst-case, screw construct." This suggests that at least one, and likely several, of the most challenging configurations of the device (e.g., specific screw diameter, length, and rod dimensions) were subjected to these mechanical tests.

Data Provenance: This is a pre-clinical, in-vitro study, meaning it was conducted in a laboratory setting using physical specimens of the device, not on humans. Therefore, there is no country of origin for clinical data, nor is it retrospective or prospective in the clinical sense. The data is generated directly from mechanical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This being a mechanical performance study, the ground truth is established by the ASTM F1717 standard, which outlines the specific testing methodologies and criteria for pedicle screw systems. The "experts" in this context are the standardization bodies and engineers who developed and validated the ASTM F1717 standard itself. No additional external experts are typically used to establish a subjective "ground truth" for each specific test sample in such a study, as the test parameters are objective and defined by the standard.

4. Adjudication Method for the Test Set

Not applicable for a mechanical performance study. The outcome of each test (e.g., failure load, fatigue life) is a direct, measurable result, not subject to individual interpretation or adjudication by multiple parties in the same way clinical outcomes would be. The raw data from the testing equipment is the primary record.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance or diagnostic accuracy of algorithms or imaging devices where human interpretation is involved. The Picasso MIS Spinal System is a physical implant, and its performance is assessed through mechanical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This term typically refers to the evaluation of AI algorithms. The Picasso MIS Spinal System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used in this study is objective mechanical performance data as defined by the ASTM F1717 standard. This standard specifies how pedicle screw systems should be tested for static and dynamic strength and provides guidelines for their acceptance. The performance of the Picasso MIS Spinal System was compared against the performance of a predicate device under these standardized test conditions.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is a mechanical engineering study, not an AI or machine learning study.

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

Not applicable. As there is no training set, there is no corresponding ground truth for it.

Summary

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9 2012 AUG

510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

Submitter: 1.

AccelSpine LLC. 14850 Quorum Dr.Suite220 Dallas, TX 75254 Phone.800.713.9489 (ext.11) FAX.888.831.4892 Daniel Chon (Mr.) dchon@accelspine.com

Contact Person:

Date prepared: March 6, 2012

2. Device Identification

Proprietary Name	Picasso MIS Spinal System
Common Name	Pedicle Screw Spinal System
Product Code	MNI,MNH, NKB
	Classification Name Pedicle Screw Spinal System (888.3070)

Predicate or legally marketed devices which are substantially equivalent 3.

L&K BIOMED: VENUS BASIC Spinal Fixation System (K103085) .
L&K Biomed : FOCUS MIS System(K 112643, K 120140) ●
STRYKER SPINE: MANTISTM Spinal System (K061813) �
DEPUY SPINE: Expedium TM MIS Spine System (K041801,K090648) .

4. Description of the Device

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ട്. Intended use

The Picasso MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

6. Comparison of the technology characteristics of the device to predicate and legally marketed devices

There are no significant differences between the Picasso MIS Spinal Systemand other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function and intended use.

7. Performance Data

Static compression bending, tension and dynamic compression bending were performed according to ASTM F1717 on a worst-case, screw construct. The mechanical test results demonstrated that the Picasso MIS Spinal SystemSystem performs as well as the predicate device.

8. Conclusion

The Picasso MIS Spinal System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Accel Spine % Mr. Daniel Chon 14850 Ouorom Drive, Suite 220 Dallas, Texas 75254

Re: K120714

Trade/Device Name: Picasso MIS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 08, 2012 Received: May 21, 2012

Dear Mr. Chon:

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 r lease be actived that i Dr. I would be complies with other requirements of the Act that I Drilland statutes and regulations administered by other Federal agencies. You must or any I vith 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

. AUG 9 2012

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Page 2 - Mr. Daniel Chon

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 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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Indications for Use

510(k) Number : K 120714

Picasso MIS Spinal System Device Name :

Indications for Use :

The Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

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)

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

KI20714 510(k) Number_

PICASSO MIS Spinal Fixation System

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.