The Calvary Spine Pedicle Screw System is 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 thoracic, lumbar, and sacral spine (T1 to S1/ilium); degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

Calvary Spine Pedicle Screw System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight and curved rods.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calvary Spine Pedicle Screw System:

Based on the provided FDA 510(k) summary (K201568), there is no information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI/algorithm-based medical device.

The document describes a traditional medical device, specifically a pedicle screw system, which is a hardware implant used in spinal fusion surgery. The "acceptance criteria" discussed in this document refer to the regulatory requirements for establishing substantial equivalence to previously cleared predicate devices, primarily based on design, materials, and mechanical performance through non-clinical testing.

Therefore, I cannot populate most of the requested fields because they are specifically tailored for studies validating AI/algorithm performance.

However, I can extract the relevant information regarding the type of study and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device and not an AI/algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC to list as acceptance criteria for automated diagnosis or analysis. The "acceptance criteria" for this device are broadly the demonstration of substantial equivalence to predicate devices based on:

Acceptance Criteria (Broad Interpretation for Traditional Device)	Reported Device Performance (Summary)
Intended Use Equivalence	Equivalent to predicate devices.
Material Equivalence	Uses same materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo).
Design Equivalence	Equivalent in shape, sizes, material, manufacturing process.
Strength Equivalence	Greater or equivalent strength values compared to predicate devices.

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

Not applicable (N/A) for an AI/algorithm test set.
The "test set" in this context refers to the samples used in non-clinical mechanical testing, which are typically manufactured units of the device. No information on the specific number of units tested for each mechanical test is provided, but it would involve standard engineering sample sizes for material and mechanical property evaluations.
Data Provenance: The data provenance for mechanical testing would be from internal laboratory testing of the manufactured devices. No country of origin for data in the AI sense is relevant here, nor is retrospective or prospective human data.

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

N/A for an AI/algorithm test set.
Ground truth for mechanical properties is established through standard engineering and materials testing protocols (e.g., ASTM standards), not by human experts adjudicating images or clinical data.

4. Adjudication Method for the Test Set

N/A for an AI/algorithm test set.
Mechanical test results are objective measurements against defined standards, not subject to human adjudication methods like 2+1 or 3+1.

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

No. An MRMC study was not done.
This device is not an AI/algorithm, therefore, there is no human-in-the-loop performance improvement with AI assistance to measure.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. A standalone algorithm performance study was not done.
This device is not an AI/algorithm.

7. The Type of Ground Truth Used

Mechanical and Material Standards: The "ground truth" for this medical device's performance is compliance with established material specifications (e.g., ASTM F136, F67, F1582) and mechanical testing standards for spinal implants, demonstrating equivalent or superior strength to predicate devices.

8. The Sample Size for the Training Set

N/A for an AI/algorithm training set.
This device does not involve a training set as it's not an AI/algorithm.

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

N/A for an AI/algorithm training set.
Not applicable as there is no training set.

Summary of what was done (based on the provided text):

The Calvary Spine Pedicle Screw System underwent non-clinical testing to demonstrate that it is substantially equivalent to legally marketed predicate devices. This equivalence was established based on:

Similar materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo).
Similar intended use.
Similar design (shape, sizes, manufacturing process).
Comparable or superior strength values, presumably measured through mechanical testing (though specific tests and methodology are not detailed in this summary).

The document explicitly states: "No clinical studies were performed." This is common for 510(k) clearances where substantial equivalence can be demonstrated through non-clinical data.

Summary

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November 12, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Calvary Spine, LLC % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven. Utah 84401

Re: K201568

Trade/Device Name: Calvary Spine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: October 12, 2020 Received: October 15, 2020

Dear J.D. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'Neill. M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K201568

Device Name

Calvary Spine Pedicle Screw System

Indications for Use (Describe)

The Calvary Pedicle Screw System is 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 thoracic. Iumbar, and sacral spine (T1 to S1/ilium); degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: Calvary Spine Pedicle Screw System

Date Prepared	September 14, 2020
Submitted By	Calvary Spine, LLC308 North Wind RoadTowson, MD 21204
Primary Contact	J.D. Webb4313 W. 3800 SWest Haven, UT 84401512-590-5810 Telee-mail: jdwebb@orthomedix.net
Trade Name	Calvary Spine Pedicle Screw System
Common Name	Thoracolumbosacral Pedicle Screw System
Classification Name	Thoracolumbosacral Pedicle Screw System
Class	II
Product Code	NKB
CFR Section	21 CFR section 888.3070
Device Panel	Orthopedic
Primary PredicateDevice	S100 Pedicle Screw System, Renovis Surgical Technologies (K101682)
Reference PredicateDevices	EXPEDIUM®/Viper Spine System, Medos International SARL (K111136 / K131802 /K200245)Synergy VLS - open, Cross Medical (K940631 / K950099)PWB (now Synergy), Cross Medical (K920116)Moss Miami SS, DePuy Spine (K000536)Moss Miami Ti, DePuy Spine (K955348)
Device Description	Calvary Spine Pedicle Screw System includes screws and connecting components in awide variety of sizes and shapes, which can be locked in various configurations, eachassembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straightand curved rods.
Materials	Ti-6Al-4V ELI per ASTM F136CP Titanium per ASTM F67CoCrMo per ASTM F1582
Intended Use	The Calvary Spine Pedicle Screw System is a spinal fixation system intended to helpprovide immobilization and stabilization of spinal segments as an adjunct to fusion of thethoracic, lumbar, and/or sacral spine.
SubstantialEquivalence Claimedto Predicate Devices	The Calvary Spine Pedicle Screw System is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety andperformances.
Indications for Use	The Calvary Spine Pedicle Screw System is intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunct to fusion in thetreatment of the following acute and chronic instabilities or deformities of thoracic, lumbar,and sacral spine (T1 to S1/ilium): degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographicstudies), degenerative spondylolisthesis with objective evidence of neurologicalimpairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/orlordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.When used for posterior, non-cervical (T1 to S1/ilium), pedicle screw fixation in pediatricpatients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct tofusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) includingidiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, theCalvary Spine Pedicle Screw System is intended to treat pediatric patients diagnosed withspondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis,and/or failed previous fusion.This system is intended to be used with autograft and/or allograft. Pediatric pedicle screwfixation is limited to a posterior approach.
Summary of thetechnologicalcharacteristicscompared topredicate	Intended UseThe Calvary Spine Pedicle Screw System and the predicate device are spinal fixationsystems intended to help provide immobilization and stabilization of spinal segments asan adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
	All of the devices comply with the indications for use specified in 21 CFR section 888.3070for thoracolumbosacral pedicle screw systems.
	MaterialThe Calvary Spine Pedicle Screw System uses the same material as the predicate.
	DesignThe Calvary Spine Pedicle Screw System and the predicate are equivalent in termsof shape, sizes, material, and manufacturing process.
	StrengthThe Calvary Spine Pedicle Screw System has greater or equivalent strength valuescompared to other devices cleared for use in the thoracolumbosacral spine.
	Non-clinical TestSummary
	The results of these evaluations indicate that the Calvary Spine Pedicle Screw System isequivalent to predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Calvary Spine, LLC considers the Calvary Spine Pedicle Screw System to be equivalentto the predicate devices listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications for use

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.