The PSS System is 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor: pseudoarthrosis; and failed previous fusion.

Device Description

The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

AI/ML Overview

This document describes a spinal fixation system (PSS System) and its regulatory clearance, but it does not contain the type of study that would typically involve acceptance criteria, performance metrics, ground truth, or expert review in the context of AI/device performance.

The provided text pertains to a 510(k) premarket notification for a medical device (a pedicle screw spinal system). This regulatory pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and material specifications, not clinical or diagnostic performance evaluated against expert ground truth.

Therefore, many of the requested elements for the study (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or not present in this type of regulatory submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

Not Applicable in this context. The focus of this 510(k) is mechanical equivalence. The "performance" is primarily mechanical strength and durability.
The study cited is "Testing in accordance with ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'".
Acceptance Criteria (Implied): The PSS System must perform "substantially equivalent" to the predicate device (Spinal USA PSS System K071438) when tested according to ASTM F1717. This standard would define specific mechanical tests (e.g., static and dynamic compression, bending, torsion) and their corresponding pass/fail criteria or performance metrics (e.g., maximum load, stiffness, fatigue life).
Reported Device Performance: The document states: "Testing in accordance with ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model' of the PSS System demonstrates that the device is substantially equivalent to the Spinal USA PSS System (K071438)." Specific numerical performance data from the ASTM F1717 test are not provided in this summary.

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

Not Applicable (direct interpretation of "test set" for performance evaluation). For mechanical testing, the "sample size" would refer to the number of physical device constructs tested. This information is not provided in the summary but would be detailed in the full test report.
Data Provenance: The testing was conducted internally by Spinal USA, presumably in a laboratory setting (Country of Origin: USA, as the submitter information is in Mississippi). This is a prospective test in the sense that the new device was built and specifically tested against the standard.

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

Not Applicable. The "ground truth" for mechanical testing is defined by the physical properties and performance measured under controlled laboratory conditions according to the ASTM standard, not by expert human interpretation.

4. Adjudication method for the test set

Not Applicable. Mechanical test results are objective measurements (e.g., force, displacement, cycles to failure), not subject to human adjudication for discrepancies.

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 device, not an AI-powered diagnostic or assistive tool.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

Mechanical Integrity/Performance according to ASTM F1717 Standard. The "ground truth" is the objective physical behavior of the device under specified loads, measured against the requirements of the standard and compared to the predicate device's performance.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

Not Applicable.

In summary: The provided document is a regulatory submission for a physical medical device. The "study" mentioned is a mechanical performance study designed to establish substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. It does not involve the types of clinical performance evaluations, expert ground truth, or AI-specific metrics that your questions are geared towards.

Summary

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Date Summary Prepared:

January 5, 2009

Spinal USA Submitter Information:

2050 Executive Drive Pearl, MS 39208

Jeffrey Johnson Contact Name: 601-420-4244 Phone: 601-420-5501 Fax: jeff(@spinalusa.com E-mail:

MAY - 6 2009

Device Trade Name:

PSS System

Common Name:

Pedicle Screw Spinal System MNH (Class II) 888.3070(b)(1) MNI (Class II) 888.3070(b)(1)

INTENDED USE:

DEVICE DESCRIPTION:

EQUIVALENT DEVICE:

Testing in accordance with ASTM F171 7 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" of the PSS System demonstrates that the device is substantially cquivalent to the Spinal USA PSS System (K071438).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal USA Holdings, Inc. c/o Mr. Jeffrey Johnson 2050 Executive Drive Pearl, Mississippi 39208

Re: K090033

Trade/Device Name: PSS® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: April 2, 2009 Received: April 6, 2009

Dear Mr. Johnson:

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.

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. Jeffrey Johnson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address littp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Daniel Krone

Image /page/2/Picture/6 description: The image contains a close-up of a handwritten word, possibly a signature or part of a longer text. The writing is in cursive, with thick, dark strokes that create a flowing, connected appearance. The specific word or letters are not entirely clear due to the partial view and the style of handwriting.

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 (if known): Ko 9 0 0 3 3

. Device Name: PSS System

Indications for Use:

X 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)

Daniel Krone for MKM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090033

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.