The Lancer Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

Device Description

The Lancer Pedicle Screw System is comprised of polyaxial pedicle screws, rods and crosslinks. The system consists of a variety of color coded top loading pedicle screws. The rods are Ø5.5mm and are available in straight and pre-lordosed (curved) configurations. The cross linkage assemblies fit over the rods to supply torsional stability to the construct.

AI/ML Overview

The provided document is a 510(k) summary for the Lancer Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information you're asking for, which is typical for AI/ML device evaluations or drug trials (e.g., acceptance criteria tables with performance, sample sizes for test/training sets in an AI context, expert ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training data details), is largely not applicable to this specific document.

However, I can extract the relevant "acceptance criteria" information in the context of what is provided in a 510(k) for a device like this, which primarily relates to non-clinical performance and substantial equivalence.

Here's a breakdown of the available information:

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

For a pedicle screw system, "acceptance criteria" are not reported as clinical performance metrics (like sensitivity/specificity for an AI model). Instead, acceptance criteria are met by demonstrating a device's substantial equivalence to predicate devices in terms of intended use, design, materials, and mechanical strength, along with meeting certain recognized standards for mechanical testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Lancer Pedicle Screw System)
Intended Use	Meets the same intended use as predicate devices: immobilization and stabilization of spinal segments for specific conditions (fracture, dislocation, spondylolisthesis, etc.)
Design	Polyaxial pedicle screws, rods (Ø5.5mm, straight & pre-lordosed), crosslinks. Design modifications (geometry of screw head, added screw/rod diameters, pre-bent rods, rod lengths) were compared to predicates.
Materials	Manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
Function	Provides immobilization and stabilization of spinal segments until fusion.
Mechanical Strength (per ASTM F1717)	Successfully underwent: - Static compression bending - Static torsion - Dynamic compression bending

Study that proves the device meets acceptance criteria:

The study proving the device meets its "acceptance criteria" (i.e., demonstrates substantial equivalence and mechanical performance) is the non-clinical testing conducted in accordance with ASTM F1717. The document states:

"The Lancer Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and strength."
"The following tests were conducted per ASTM F1717: Static compression bending, Static torsion, Dynamic compression bending."

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

Sample Size for Test Set: This concept doesn't apply to this 510(k) in the way it would for an AI/ML device or clinical trial. The "test set" here refers to the actual physical devices (Lancer Pedicle Screw System components) that underwent mechanical testing. The specific number of physical samples tested is not reported in this summary, but device manufacturers typically test multiple units to meet ASTM F1717 standards.
Data Provenance: Not applicable in the context of clinical data provenance. The data comes from in-vitro mechanical testing performed on the device components.

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. There is no "ground truth" in the clinical AI sense for this device as no clinical data or image interpretation by experts was involved for regulatory submission. Mechanical tests are typically performed by engineers/technicians in a laboratory setting according to established standards.

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

This question is not applicable. Adjudication methods are relevant for clinical endpoints, especially in situations involving human interpretation or subjective assessments. Mechanical tests are objective measurements.

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 systems or AI devices. The Lancer Pedicle Screw System is a physical implant, not an imaging or diagnostic device.

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

This question is not applicable. This is not an AI algorithm.

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

The "ground truth" for the mechanical performance of the device is defined by the acceptance criteria within the ASTM F1717 standard (e.g., minimum loads, fatigue life, etc.). The device passes if it meets or exceeds these pre-defined mechanical benchmarks, which are typically derived from historical data on predicate devices and clinical expectations for device durability.

8. The sample size for the training set

This question is not applicable. There is no "training set" for physical mechanical devices in the context of this 510(k). The device's design and manufacturing process are informed by engineering principles and prior device knowledge, but not by a data-driven "training" process in the AI sense.

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

This question is not applicable.

Summary

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510(k) Summary for the Lancer Pedicle Screw System

DEC 1 5 2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Lancer Pedicle Screw System.

Date Prepared: March 1, 2011

Submitter:	Contact Person:
Spinal Solutions LLC	J.D. Webb
26157 Jefferson Avenue	The OrthoMedix Group, Inc.
Murrieta, CA 92562	1001 Oakwood Blvd
(951) 304-9001	Round Rock, TX 78681
	Telephone: 512-388-0199

Trade name: Lancer Pedicle Screw System orthosis, pedicle screw system Common Name: Classification Name: pedicle screw spinal system 21 CFR Sec. 888.3070 MNH MNI Class II

3. Predicate or legally marketed devices which are substantially equivalent:

The Lancer Pedicle Screw System is a modification of the Orthopedic Alliance Spine System (K033826). Other predicate devices include: KRD-1™ - K092420 (SpineFrontier)

4. Description of the device:

Purpose of 510(k):

The purpose of this 510(k) is to modifications to the Orthopedic Alliance Spine System. These changes include, changing the geometry of the pedicle screw head, add pedicle screw diameters, screw lengths, rod diameter, pre-bent rods, and rod lengths.

Materials:

The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

Function:

The Lancer Pedicle Screw System is a pedicle screw system intended to provide immobilization and the stabilization of spinal segments until fusion takes place.

5. Substantial equivalence claimed to predicate devices

Lancer Pedicle Screw System is substantially equivalent to the Orthopedic Alliance Spine System and the KRD-1™ in terms of intended use, design, and materials used. The table below compares the features and characteristics of the Lancer Pedicle Screw System to these predicate devices.

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DeviceName	Lancer PedicleScrew System	OrthopedicAlliance SpineSystem	KRD-1TM
Items
Sponsor	Spinal Solutions	Orthopedic Alliance	SpineFrontier
510(k) Number	N/A	K033826	K092420
DeviceClassificationName	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070
Product Code	MNI, MNH	MNI, MNH	MNI, MNH
Class	Class II per 21 CFR888.3070	Class II per 21 CFR888.3070	Class II per 21 CFR888.3070
Straight rods	Yes	Yes	Yes
Pre-bent rods	Yes	No	Yes
Rod material	Ti-6Al-4V per ASTMF136	CP titanium perASTM F67	Ti-6Al-4V per ASTMF136
Screw loading	Tulip top loading	Tulip top loading	Tulip top loading
Screw material	Titanium alloy perASTM F136	Titanium alloy perASTM F136	Titanium alloy perASTM F136
Crosslinks -length	Yes	Yes	Yes

The following devices were used as predicate devices for strength comparison only:

Synergy VLS open, K000236 (DePuy) .
Moss Miami SS, K950697 (DePuy) .

6. Intended Use:

When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-51 vertebrae 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.

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7. Non-clinical Test Summary:

The following tests were conducted per ASTM F1717:

Static compression bending .
. Static torsion
Dynamic compression bending .

Clinical Test Summary 8.

No clinical studies were performed

9. Conclusions Nonclinical and Clinical

The Lancer Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and strength.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

DEC 15 2011

Spinal Solutions LLC % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K110633

Trade/Device Name: Lancer Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 13, 2011 Received: November 18, 2011

Dear Mr. Webb:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. J.D. Webb

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erind Keith

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): K110633

Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

K110633 510(k) Number_

Regulation Number and Section

N/A