The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Device Description

The Life Spine Anterior Lumbar Fixation System (Presidio) consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided text describes the 510(k) summary for the "Life Spine Anterior Lumbar Fixation System (Presidio™)". It details the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, the document does not present acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a medical device's performance validation using a test set of data with ground truth, especially for AI/ML devices.

Instead, the performance data section states: "Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices." This implies that the 'acceptance criteria' are related to meeting or demonstrating equivalence in biomechanical properties to already cleared devices, rather than a specific numerical target for a diagnostic or predictive performance metric.

Therefore, many of the requested items (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable or not provided in the context of this 510(k) submission, which focuses on demonstrating substantial equivalence through biomechanical testing for a spinal fixation system, not an AI/ML diagnostic or prognostic device.

Here's an attempt to structure the answer based on the available information and highlighting what is not provided:

Acceptance Criteria and Device Performance for Life Spine Anterior Lumbar Fixation System (Presidio™)

The provided document describes a spinal fixation system, not an AI/ML device, and thus the performance evaluation focuses on biomechanical equivalence rather than diagnostic or predictive accuracy against a test set with ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from 'Substantial Equivalence')	Reported Device Performance
Biomechanical Performance	Demonstrate substantial equivalence to predicate devices via in vitro biomechanical testing in accordance with appropriate ASTM standards.	"Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices."
Indications for Use	Equivalence in intended use compared to predicate devices.	"The Life Spine Anterior Lumbar Fixation System (Presidio) was shown to be substantially equivalent to previously cleared devices in indications for use..."
Design, Function, Materials	Equivalence in design, function, and materials used compared to predicate devices.	"...design, function, and materials used."

Note: The document does not specify quantitative thresholds or specific biomechanical test results (e.g., stiffness, fatigue life, pull-out strength in N or cycles) that would constitute 'acceptance criteria'. The acceptance is based on demonstrating "substantial equivalence" to predicate devices through these tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not applicable in the context of an AI/ML device. For biomechanical testing, the sample size (number of constructs tested) is not specified.
Data Provenance: Not applicable for a typical AI/ML data provenance. The "data" refers to results from in vitro biomechanical tests, not patient data from a specific country or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. Ground truth as understood in AI/ML validation (e.g., expert consensus on image findings, pathology reports) is not relevant for the biomechanical testing of this physical medical device. The "truth" in this context is established by the validated biomechanical testing methods and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert annotations or diagnoses, which is not relevant for biomechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. It is not applicable to the biomechanical testing of a spinal implant.
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No. This relates to AI/ML algorithm performance. The device is a physical spinal fixation system, not a software algorithm.

7. Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for the biomechanical testing would be the measured physical properties (e.g., range of motion, load-to-failure) of the tested constructs, assessed against established ASTM standards and data from predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device. Biomechanical testing involves evaluating a sample of manufactured devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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Submitted By:	Life Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118	JAN 1 9 2010
510(k) Contact:	Charles P. GillLife Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	October 6, 2009
Trade Name:	Life Spine Anterior Lumbar Fixation System (Presidio)
Common Name:	Spinal Fixation System
Classification:	KWQ, 21 CFR 888.3060, Class II

510(k) Summary Life Spine Anterior Lumbar Fixation System (Presidio™)

Device Description:

Intended Use of the Device:

Performance Data:

Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices.

Substantial Equivalence:

The Life Spine Anterior Lumbar Fixation System (Presidio) was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of a stylized bird with outstretched wings, symbolizing protection and care.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 9 2010

Life Spine % Mr. Charles P. Gill Director Regulatory Affairs/ Quality Assurance Manager 2401 W. Hassell Road - Suite 1535 Hoffman Estates, Illinois 60169

Re: K093200

Trade/Device Name: Life Spine Anterior Lumbar Fixation System (Presidio ") Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 04, 2010 Received: January 05, 2010

Dear Mr. Gill:

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. Iisting 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

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Page 2 - Mr. Charles P. Gill

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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kailara buelum

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):

Device Name: Life Spine Anterior Lumbar Fixation System (Presidio™)

Indications for Use: The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

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)

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

Page 1 of 1

K093200 510(k) Number_

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Sponsor:	Nexxt Medical, Inc.10142 Brooks School RoadFishers, IN 46037Phone (317) 436.7801Fax (317) 245.2518	JAN 1 9 2010
Contact Person:	Andy Elsbury, President
Proposed Trade Name:	Blade™ Anterior Cervical Plate System
Device Classification	Class II
Classification Name:	Appliance, fixation, spinal intervertebral body
Regulation:	888.3060
Device Product Code:	KWQ
Device Description:	The Blade™ Anterior Cervical Plate System consists of and screws andplates in a variety of sizes. One-, two- and three-level plates are offered.Screws are available in two diameters in both self-tapping and self-drillingversions. The Blade™ Anterior Cervical Plate System components aremanufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTMF136 or titanium (Grade 2 or 4) as described by ASTM F67.
Intended Use:	The Blade™ Anterior Cervical Plate System is intended for anterior screwfixation of the cervical spine. These implants have been designed to providestabilization as an adjunct to cervical fusion. Indications for the use of thisimplant system include degenerative disc disease (defined as neck pain ofdiscogenic origin with the degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fractures ordislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis orscoliosis), tumor, pseudarthrosis or failed previous fusion.WARNING: The Blade™ Anterior Cervical Plate System is not intendedfor screw attachment or fixation to the posterior elements (pedicles) of thecervical, thoracic or lumbar spine.
SubstantialEquivalence:	Documentation was provided which demonstrated the Blade™ AnteriorCervical Plate System to be substantially equivalent to previously cleareddevices: The substantial equivalence is based upon equivalence in basicdesign, intended use, indications, anatomic sites and mechanicalperformance.

September 19.

8. 510(k) Summary

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.