The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients:

Who are receiving fusions with autogenous graft only;

Who are having the device fixed or attached to the lumbar or sacral spine: ●
Who are having the device removed after the development of a solid . fusion mass."

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

Device Description

The subject systems are comprised of a variety of pedicle screws and Couplers that act as longitudinal spacers. The systems are intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.

The subject systems are fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136).

AI/ML Overview

Here's an analysis of the provided text regarding the DSS™ Stabilization System and its submission for 510(k) clearance:

Important Note: The provided text is a 510(k) Summary for a medical device. 510(k) clearances for devices like this (pedicle screw spinal systems) typically do NOT involve AI, machine learning, or software-based diagnostics. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical and material performance testing. Therefore, many of the questions related to AI/ML and human-in-the-loop performance will not be applicable.

Acceptance Criteria and Device Performance (Based on provided text)

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Material Equivalence	Fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136), same as predicate.
Design Equivalence	Same design as predicate devices.
Function Equivalence	Same function as predicate devices.
Intended Use Equivalence	Same intended use as predicate devices.
Indications for Use Equivalence	Same indications for use as predicate devices.
Performance Standards Testing	"Testing performed indicates the subject systems are substantially equivalent to predicate devices."

Explanation of "Acceptance Criteria" for this device: For a 510(k) pathway for a pedicle screw spinal system, "acceptance criteria" are not typically framed as specific statistical thresholds for diagnostic performance (like sensitivity/specificity for an AI device). Instead, they revolve around demonstrating substantial equivalence to a predicate device. This involves showing that the new device is as safe and effective as a legally marketed device that performs the same function. The primary evidence for this in the provided document is through:

Material composition: Matching established standards and predicate devices.
Design, Function, Intended Use, Indications for Use: Being demonstrably similar to predicate devices.
Performance Testing: While the details are not given, this would involve mechanical testing (e.g., static and dynamic compression, bending, torsion) to ensure the device meets or exceeds the mechanical properties and safety profiles of the predicate, as per relevant ASTM or ISO standards for spinal implants. The "Performance Standards" section vaguely states that testing confirms substantial equivalence.

Study Details (Based on provided text)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. For a mechanical device, testing would involve a sufficient number of devices/components to establish statistical significance for mechanical properties, but the specific number is not provided in this summary.
- Data Provenance: Not applicable for AI/ML. The "data" here would be the results of mechanical and material tests, likely conducted in a controlled laboratory environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to regulatory compliance and mechanical performance, not a diagnostic assessment by experts. Design and manufacturing were likely overseen by engineers and quality control personnel.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for substantial equivalence is primarily based on:
  - Compliance with recognized standards: Material standards (ISO 5832-3, ASTM F136).
  - Reproducibility of mechanical properties: Laboratory-tested mechanical performance comparing the new device to the predicate device and relevant industry standards for spinal implant strength and durability.
  - Pre-clinical data: Likely involved bench testing and potentially biomechanical cadaver studies (though not explicitly detailed in the summary).
The sample size for the training set:
- Not applicable. There is no AI/ML training set.
How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set.

Summary for K090099:

This 510(k) summary is for a pedicle screw spinal system, a mechanical implant. The entire submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices. This means proving that the new device has the same intended use, indications for use, technological characteristics (materials, design, function), and performs as safely and effectively as the predicate. The "study" here refers to the engineering and performance testing that verifies the device's mechanical integrity and material compliance, not a clinical trial or an AI/ML validation study.

Summary

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K090099

510(k) Summary

JUN 19 2009

Contact:	Mr. Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	DSSTM Stabilization System - Rigid Coupler
Manufacturer:	Paradigm Spine, LLC505 Park Ave. 14th FloorNew York, NY 10022212.583.9700
Common Name:	Pedicle screw spinal system.
Classification:	21 CFR §888.3070・・・・・・・
Class:	III
Product Code:	NKB, MNH, MNI

Indications For Use:

DSS™ Stabilization System - Rigid

The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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/or lordosis); turnor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted

The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments 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, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients:

Who are receiving fusions with autogenous graft only;

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Who are having the device fixed or attached to the lumbar or sacral spine: ●
Who are having the device removed after the development of a solid . fusion mass."

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

Device Description:

The subject systems are fabricated from wrought Ti-6A1-4V (ISO 5832-3 and ASTM F136).

Predicate Device(s):

The subject systems were shown to be substantially equivalent to previously cleared devices and has the same indications for use, intended use, design, function, and materials used.

Performance Standards:

Testing performed indicates the subject systems are substantially equivalent to predicate devices. :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUN 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paradigm Spine % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street Northwest, 12th Floor Washington, DC 20005

Re: K090099

Trade Name: DSS™ Stabilization System- Rigid DSSTM Stabilization System- Slotted Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, NQP, MNI, MNH Dated: April 8, 2009 Received: April 14, 2009

Dear Mr. Eggleton:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

"The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. This device is only intended to be used when fusion with bone graft is being performed at all instrumented levels."

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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" (21CFR 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/cdrl/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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Donna-Bea Tillman, Ph.D., M.P.A.

Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

DSSTM Stabilization System - Rigid

The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted

In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients:

Who are receiving fusions with autogenous graft only; ●
Who are having the device fixed or attached to the lumbar or sacral spine;
Who are having the device removed after the development of a solid fusion mass."

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

Prescription Use マ (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)

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

510(k) Number K090099

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.