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); tumor: pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.

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 DSS™ 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 DSS™ Stabilization System -- Rigid is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V). This submission presents the addition of a 20mm long rigid coupler.

AI/ML Overview

The provided text describes a medical device, the DSS™ Stabilization System -- Rigid, and its 510(k) premarket notification (K101083). The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical mechanical testing.

Here's an analysis of the provided information against the requested categories:

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

Acceptance Criteria	Reported Device Performance
Material: Medical grade titanium alloy (Ti6Al4V)	Device is manufactured from medical grade titanium alloy (Ti6Al4V).
Mechanical Performance (Static Flexion): Equivalent to predicate devices based on ASTM F1717.	Testing performed in conjunction with ASTM F1717. Performance indicates equivalence to predicate devices.
Mechanical Performance (Static Extension): Equivalent to predicate devices based on ASTM F1717.	Testing performed in conjunction with ASTM F1717. Performance indicates equivalence to predicate devices.
Mechanical Performance (Static Axial Rotation): Equivalent to predicate devices based on ASTM F1717.	Testing performed in conjunction with ASTM F1717. Performance indicates equivalence to predicate devices.
Mechanical Performance (Dynamic Compression Bending): Equivalent to predicate devices based on ASTM F1717.	Testing performed in conjunction with ASTM F1717. Performance indicates equivalence to predicate devices.
Indications for Use: Same as predicate devices.	The device has the same indications for use as predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical mechanical testing, not a clinical study involving human patients or data provenance in that sense. The "sample size" refers to the number of test articles used in the mechanical tests. The document states: "Static and dynamic mechanical testing was performed in conjunction with ASTM F1717." While it confirms that testing was done, the exact number of samples (test articles) used for each specific test (static flexion, extension, axial rotation, dynamic compression bending) is not explicitly stated.

The data provenance is from non-clinical laboratory testing of the device components, not from human subjects or clinical data.

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)

This question is not applicable to this type of submission. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties and behavior of the materials and device constructs, not by expert human interpretation.

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

This question is not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions on clinical outcomes or image interpretations. For mechanical testing, the results are derived from physical measurements and engineering analyses, not subjective interpretation requiring "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

This question is not applicable. An MRMC study is a type of clinical study used to evaluate diagnostic imaging devices or AI algorithms where multiple human readers interpret cases. This submission is for a spinal implant, which undergoes mechanical testing and not typically MRMC studies for its premarket clearance.

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

This question is not applicable. This device is a physical spinal implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for this submission's non-clinical testing is based on established engineering standards and material science principles, specifically ASTM F1717. The performance of the device is measured against the expected mechanical properties and behavior defined by this standard and compared to the performance of predicate devices.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a mechanical device is its design and manufacturing process according to engineering principles.

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

This question is not applicable, as there is no "training set" in the context of this traditional medical device submission.

Summary

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K101083

ge 1 of 2

510(k) Summary

JUL - 2 2010

Contact:	Ms. Michelle McDonoughMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Tel: 202.552.5800Fax: 202.552.5798
Device Trade Name:	DSST™ Stabilization System -- Rigid
Manufacturer:	Paradigm Spine, LLC505 Park Ave. 14th FloorNew York, NY 10022
Classification:	21 CFR §888.3070, Pedicle screw spinal system
Class:	III
Product Code:	NKB, MNH, MNI
Date Prepared:	April 15, 2010

Indications For Use:

DSS™M 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, kyphosis, 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

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 DSS™ 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;
K101 083
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 DSSTM Stabilization System -- Rigid is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V). This submission presents the addition of a 20mm long rigid coupler.

Predicate Device(s):

DSSTM Stabilization System -- Rigid was shown to be substantially equivalent to previously cleared devices (K080241, K090408. K090099. and K091944) and has the same indications for use, design, function, and materials used.

Non-clinical Testing:

Static and dynamic mechanical testing was performed in conjunction with ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model). Testing included static flexion, static extension, and static axial rotation testing and dynamic compression bending testing.

Conclusion:

Performance testing indicates the DSS™ Stabilization System -- Rigid has equivalent performance to predicate devices.

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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 features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

: :

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

'JUL-- 2 2010

Paradigm Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Michelle McDonough 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K101083 Trade/Device Name: DSS™ Stabilization System -- Rigid Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: June 29, 2010 Received: April 19, 2010

Dear Ms. McDonough:

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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Page 2 - Ms. Michelle McDonough

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. 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/cdrh/industry/support/index.html.

Sincerely vours.

Christy Foreman Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

11101083 510(k) Number (if known): __

Device Name: DSS™ Stabilization System

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, kyphosis, 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 DSS™ 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 (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)

Page 24 of 44

ision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101083

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.