The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Device Description

The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V) screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.

AI/ML Overview

The provided text discusses a 510(k) premarket notification for a medical device called the SECURIS Spinal Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Here's an analysis of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance" in this context refers to regulatory acceptance based on demonstrating substantial equivalence to predicate devices, primarily through bench testing and comparison of design, materials, and indications for use.
Reported Device Performance: The document only mentions that "Bench testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance 'Guidance for Industry and FDA Staff: Spinal System 510(k)s.'" The specific tests performed were:
- Static Compression Bending
- Static Torsion
- Dynamic Compression Bending
- These tests were conducted in accordance with ASTM F1717.
The actual quantitative results or direct comparison to predicate device performance values for these tests are not provided in the summary. The summary only states that documentation was provided to demonstrate substantial equivalence through these comparisons.

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

Test set sample size: Not applicable, as this was a bench testing study, not a clinical study involving patients. The sample size would refer to the number of test articles (e.g., screws, rods) tested, which is not specified in the provided text.
Data provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from the testing laboratory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical ground truth established for this device submission within the provided text. Bench testing relies on established engineering standards (ASTM F1717).

4. Adjudication method for the test set:

Not applicable. There was no clinical test set requiring expert adjudication.

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:

No, an MRMC study was NOT done. This document pertains to a spinal fixation system, not an AI-powered diagnostic device, and thus, this type of study is irrelevant.

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

No, a standalone algorithm performance study was NOT done. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

Not applicable / Engineering Standards. For the bench testing, the "ground truth" would be the established performance requirements and methods outlined in ASTM F1717 for spinal implant testing. There is no clinical or pathological "ground truth" in this context.

8. The sample size for the training set:

Not applicable. There was no training set, as this is a physical medical device, not a machine learning algorithm.

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

Not applicable. There was no training set.

In summary, the provided document is a 510(k) summary for a spinal fixation system, focusing on demonstrating substantial equivalence through bench testing against established engineering standards and comparison to predicate devices, rather than a clinical study with detailed acceptance criteria and expert-validated ground truth.

Summary

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K113361

APR - 3 2012

Section VII. 510(K) SUMMARY

Date Prepared

March 09, 2012

Name of Firm

Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707

Official Correspondent

David Brumfield Senior VP of Research and Development, Quality, and Regulatory 1140 Parsippany Blvd. Suite 201 Parsippany, NJ 07054 Phone: (973) 265-5043 Fax: (973) 808-0707 E-mail: dbrumfield@customspine.com

Establishment Number 3005129649

Device Name

Legally Marketed Trade Name: Proposed Name SECURIS Spinal Fixation System Common Name: Pedicle Screw Spinal System Device Classification: Class III Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, MNI, MNH

Predicate Devices

Moss® Miami Spinal System (K933881, K955348, K964024, K983583, K022623), Optima® Spinal System (K031585), Synthes Pangea System (K103287), Custom Spine ISSYS LP (K070821, K 072866, K110099), ISSYS (043522).

Device Description

The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V)

Pg lot 2

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screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.

Indications for Use

"The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). "

Materials

The screws and setscrews are made from titanium (ASTM F-136, Ti-6Al-4V) and the rods are made from Cobalt-Chromium- Molybdenum (Co-28Cr-6Mo, ASTM F-1537).

Performance Data

Bench testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance "Guidance for Industry and FDA Staff: Spinal System 510(k) s." The following testing was performed in accordance with ASTM F1717: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.

Substantial Equivalence Statement

Documentation is provided which demonstrates that the Securis Spinal System is substantially equivalent to its predicate devices in terms of its material, design, and indications for use, and performance characteristics. Those comparisons are made in the substantial equivalence tables and the executive summary comparing the materials used in the systems, indications for use, and mechanical test data. The design characteristics of the SECURIS Spinal Fixation System is similar in technology (interconnections between the polyaxial head and bone screw) as the previously cleared ISSYS LP ((K070821, K 072866, K110099) and ISSYS (K043522) Polyaxial Screw Systems.

P 2.082

113361

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be printed on a white background. The words are arranged on a single line, with "Public" and "Health" capitalized, and "Service" also capitalized.

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

Custom Spine, Incorporated % Mr. David Brumfield Senior VP of Research and Development, Quality and Regulatory 1140 Parsippany Boulevard, Suite 201 Parsippany, New Jersey 07054

Re: K113361

Trade/Device Name: SECURIS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: February 15, 2012 Received: February 15, 2012

APR - 3 2012

Dear Mr. Brumfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) to 10g. 3 the enactment date of the Medical Device Amendments, or to conninered print to Milly 20, 1977, in ecordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmotion Actore, market the device, subject to the general controls provisions of the Act. The r ou may, merciols, manot alle a ct include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Trease noter ODFLEVE, 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 If your device is classified (boo acove). Existing major regulations affecting your device can be may be subject to additional controls. Existing of the 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 Frease be advised mar I Dri 3 losaante over device complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that I DA has made a determinations administered by other Federal agencies. You must of any I'edelal statues and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cr N Fall 607), aboning (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

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Page 2 - Mr. David Brumfield

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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K113361

Section VI. INDICATIONS FOR USE STATEMENT

KI13361 510(k) Number : ______________________________________________________________________________________________________________________________________________________________

The SECURIS Spinal Fixation System is intended for the immobilization and stabilization of the the SECONS Spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the thorace fumber back are openerative disc disease (defined by discogenic back pain with following findicudentiful and a and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and previously failed fusion (pseudoarthrosis).

Prescription Use _ × (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIT3361 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.