The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.

Device Description

The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.

AI/ML Overview

This document describes a 510(k) submission for the "Vertebral Access System by Vidacare®". This submission is for substantial equivalence to existing devices, not for demonstrating new clinical effectiveness. Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" as might be seen for a novel device demonstrating performance metrics are not directly applicable in the terms you've presented for medical imaging AI.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to legally marketed devices.

Based on the provided text, here's a breakdown in relation to your questions:

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

For a 510(k) focusing on substantial equivalence, the "acceptance criteria" are not performance metrics like sensitivity/specificity for a diagnostic device. Instead, the acceptance criteria are met by demonstrating that the new device is as safe and effective as predicate devices. The "reported device performance" is essentially that the new device shares similar technological characteristics and indications for use with the predicate devices.

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison to predicates)
Same Indications for Use	Intended for use with a standard cement delivery system for fixation of vertebral body fractures using vertebroplasty. This matches the intended use of predicate devices (implicitly, as part of the substantially equivalent finding).
Similar Target Population	Used for patients requiring vertebroplasty.
Similar Driver Design Features	The powered driver is identical to the predicate driver cleared via K072045.
Similar Needle Design	The 11-gauge, 152mm needle set is identical in gauge and length to the predicate devices (OnControl™ Bone Marrow Biopsy System (K072045) and Parallax EZFlow Cement Delivery System (K051820)).
Similar Technique	Implied to be similar given the identical/similar components and intended use.
Sterility	Disposable sterile needle set. Implied to meet sterility standards similar to predicates.
Biocompatibility	Implied to meet biocompatibility standards similar to predicates.
Similar Anatomical Sites Where Used	Vertebral body.

2. Sample size used for the test set and the data provenance

There is no "test set" in the context of an AI/diagnostic device study. This 510(k) is for a medical instrument (Vertebral Access System). Device performance is demonstrated through comparison of specifications and design features, not clinical data from a "test set" analyzing patient outcomes in the way a diagnostic AI would.

Sample size: Not applicable in this context.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a hardware medical device submission like this, there isn't a "ground truth" to establish for a test set.

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

Not applicable. There is no test set or adjudication process for clinical outcomes described in this 510(k) summary.

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

Not applicable. This is not an AI device. No MRMC study was performed or required for this type of medical instrument submission.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior FDA clearances. The new device demonstrates substantial equivalence to these predicates. This is a technical comparison of specifications and intended use, not an evaluation against a clinical ground truth for diagnostic accuracy or outcomes.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

In summary: The provided document is a 510(k) premarket notification for a medical instrument, not a diagnostic AI system. Therefore, the questions related to acceptance criteria, test sets, ground truth, experts, and AI performance metrics are not relevant to this specific regulatory submission type. The "study" proving the device meets its "acceptance criteria" is the detailed comparison of its technological characteristics and indications for use against legally marketed predicate devices, which led to the FDA's finding of "substantial equivalence."

Summary

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5. 510(k) Summary

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SUMMARY

Submitter's name: Address:

Vidacare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

NOV 21 2008

Phone: Fax number:

Name of contact person:

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821

Date the summary was prepared: November 4, 2008

Name of the device:Trade or proprietary name:Common or usual name:	Vertebral Access System by Vidacare®Vertebroplasty SystemCement Dispenser Conduit forVertebroplasty
Classification name:	Injector, vertebroplasty (does not containcement)
Classification	Class I21 CFR sec. 888.4200 Injector,vertebroplasty (does not contain cement).And21CFR sec. 878.4820 Surgical instrumentmotors and accessories/attachments.
Product Code	OAR and MOQ

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The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

	510(k) Number	Trade or Proprietary or Model Name	Manufacturer
1	K072045	EZ-IO® Bone Marrow BiopsySystem	Vidacare Corp.
2	K051820	Parallax EZFlow Cement DeliverySystem	ParallaxMedical

Description of the device:

Indications:

Summary of the technological characteristics of our device compared to the predicate device:

The predicates and the Vidacare Vertebral Access System were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Indications for Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibilitv Anatomical Sites Where Used

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vidacare Corporation % Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Specialist 3722 Avenue Sausalito Irvine, California 92606

NOV 21 2008

Re: K081713

Tradc/Device Name: Vertebral Access System by Vidacare® Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: MOQ, OAR Dated: November 7, 2008 Received: November 10, 2008

Dear Ms. Holland:

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

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Page 2 - Ms. Grace Holland

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.

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 Compliary, 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 Postmanect 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 yours.

Mark M. Millman

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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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K081713

Device Name: Vertebral Access System by Vidacare®

Indications for Use:

Prescription Use X (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) ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerm

(Division Sign-Of Division of Gene and Neurolog

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Regulation Number and Section

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.