The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment. (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the 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.

Device Description

The Savannah Lumbar Percutaneous Stabilization System is comprised of a variety of pedicle screws sizes, couplers, a ball swivel, rods and locking nuts that can be uniquely fitted for each individual case. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

AI/ML Overview

The provided text is a 510(k) summary for the Savannah Lumbar Percutaneous Stabilization System (SLPSS). It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the document states:

"The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."

This implies that the device's performance was compared to existing, legally marketed devices (predicates) rather than against specific, predefined acceptance criteria through a standalone clinical or performance study with detailed metrics. The regulatory pathway chosen, a 510(k), relies on demonstrating "substantial equivalence" to a predicate device, which often involves comparing technical characteristics and performance data to show that the new device is as safe and effective as the predicate.

Therefore, for your request, the following information is largely not present in the provided text:

A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is a surgical implant, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a surgical implant.
The type of ground truth used: Not applicable, as it's not a diagnostic device.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary of available information:

Device Name: Savannah Lumbar Percutaneous Stabilization System (SLPSS)
Regulatory Pathway: 510(k) Premarket Notification (K072116)
Claim of Performance: "The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."
Predicate Devices Listed:
- Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, K982987)
- DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, K933881)
- U&I Optima Spinal System (K031585)
- Stryker Spine Xia Spinal System (K001319, K984251, K951725)
Nature of Testing: "Pre-clinical testing" was performed to demonstrate substantial equivalence, but details of this testing (e.g., in-vitro, mechanical, benchtop) are not provided in this summary.

Conclusion:

The provided document relies on showing substantial equivalence to predicate devices based on pre-clinical testing, rather than presenting a study with specific acceptance criteria as you've requested for a device that might involve diagnostic performance or AI. Therefore, most of the detailed information you are seeking is not available in this 510(k) summary.

Summary

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K072116

Neurospine Innovations 510(k)

confidential

510(k) Summary according to 807.92(c)

Contact:	Randolph Bishop, M.D.Neurospine Innovations and Solutions14 Cotesworth PlaceSavannah, GA 31411912-958-4853	MAR 20 200
Trade Name:	Savannah Lumbar Percutaneous Stabilization System
Classification:	21 CFR §888.3070 Pedicle Screw Spinal System§888.3050 Spinal Interlaminal Fixation Orthosis
Class:	III
Product Codes:	MNI, MNH, NKB

Indications for Use:

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Neurospine Innovations 510(k)

Device Description:

Predicate Device(s):

The Savannah Lumbar Percutaneous Stabilization System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. These include the Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, and K982987), DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, and K933881), the U&I Optima Spinal System (K031585) and the Stryker Spine Xia Spinal System (K001319, K984251, and K951725).

Performance Testing:

The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neurospine Innovations and Solutions % Silver Pine Consulting Richard Jansen, Pharm.D. 13540 Guild Ave. Apple Valley, MN 55124

MAR 2 0 2008

Re: K072116

Trade Name: Savannah Lumbar Percutaneous Stabilization System (SLPSS) Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: February 29, 2008 Received: March 4, 2008

Dear Dr. Jansen:

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 such 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); 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.

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Page 2 - Richard Jansen, Pharm.D.

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

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Indications for Use:

When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

Prescription Use V (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)

Soutu
(Division Sign. Of

Division of General, Restorative, and Neurological Devices

510(k) Number_K07210 حالل2

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.