The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Device Description

The Abbott Spine, Inc. Spinnaker System is intended for use as a vertebral body biopsy and cement dispenser device. The system is comprised of aspiration/injection taps, handles, a targeting needle, a bone awl, ports and dilators, a Luer cap, and k-wire. The system provides the surgeon with a convenient method of performing vertebral body bone biopsy, as well as dispensing cement cleared for use in the spine into a vertebral body using a single system.

AI/ML Overview

The Abbott Spine, Inc. Spinnaker System is a medical device intended for use as a vertebral body biopsy and cement dispenser. The provided documentation does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics in the way that an AI/ML device study would. Instead, the summary focuses on substantial equivalence to predicate devices through mechanical testing.

Here's an analysis based on the provided text, using the requested categories where applicable:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional requirements for performing vertebral body bone biopsy.	Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for performing vertebral body bone biopsy.
Functional requirements for dispensing cement into a vertebral body for vertebral body augmentation.	Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for dispensing cement into a vertebral body for vertebral body augmentation.
Substantial Equivalence to predicate devices (Stryker Capture Vertebral Body and Bone Biopsy Kit and Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit).	The Abbott Spine Spinnaker System was determined to be substantially equivalent to the predicate devices. This determination implies meeting similar safety and effectiveness profiles as the legally marketed predicate devices.

Note: The provided document is a 510(k) summary for a medical device that predates the common rigorous performance criteria and study formats seen for AI/ML devices. Therefore, the "acceptance criteria" are implied functional requirements and substantial equivalence rather than quantitative statistical metrics (e.g., sensitivity, specificity, AUC).

Study Details (Based on available information)

Sample Size used for the test set and the data provenance: Not applicable. This 510(k) summary refers to mechanical testing, not a clinical study involving a "test set" of patient data or clinical outcomes. The "test set" for mechanical testing would refer to the number of devices or components subjected to specific engineering tests. This information is not provided in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" in this context refers to engineering specifications and performance against those specifications, not clinical diagnostic accuracy or reader performance.
Adjudication method for the test set: Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain diagnoses. Mechanical testing relies on objective measurements against engineering standards.
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. This is a traditional medical device (biopsy tool and cement dispenser), not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and AI-driven performance improvements are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; there is no "algorithm" in the sense of AI/ML.
The type of ground truth used: For mechanical testing, the ground truth would be established engineering standards, material properties, and functional specifications defined by validated test methods.
The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.
How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study described is mechanical testing. This testing evidenced that the Spinnaker System "exhibits the functional requirements" for its intended uses: vertebral body bone biopsy and cement dispensing. The specific parameters tested, the methodology, and the quantitative results of these mechanical tests are not detailed in this 510(k) summary, which is typical for such submissions where the focus is on the conclusion of meeting functional requirements for substantial equivalence. The overall determination of marketability was based on substantial equivalence to two predicate devices: the Stryker Capture Vertebral Body and Bone Biopsy Kit and the Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit.

Summary

{0}------------------------------------------------

K 052638

Abbott Spine, Inc. Spinnaker System

510(k) Summary of Safety and Effectiveness

SUBMITTED BY	Abbott Spine, Inc.5301 Riata Park Court, Bldg. FAustin, TX 78727
ESTABLISHMENTREGISTRATION NUMBER	1649384
CONTACT PERSON	Lisa PetersonRegulatory Affairs ManagerPhone: 512-533-1080Fax: 512-249-6734
DATE PREPARED	September 19, 2005
CLASSIFICATION NAME	KNW 876.1075- Gastroenterology-Urology BiopsyInstrument: Class IIKIH 888.4200- Cement Dispenser: Class I
COMMON NAME	Vertebral Body Biopsy NeedleCement Dispenser
PROPRIETARY NAME	Abbott Spine Inc. Spinnaker System
SUBSTANTIALEQUIVALENCE	The Abbott Spine Spinnaker System was determined tobe substantially equivalent to the Stryker CaptureVertebral Body and Bone Biopsy Kit and the ParallaxMedical Core-Assure Bone and Vertebral Body BiopsyKit.

DEVICE DESCRIPTION:

Abbott Spine, Inc.

{1}------------------------------------------------

INDICATIONS:

MECHANICAL TEST DATA

Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for performing vertebral body bone biopsy and dispensing cement into a vertebral body for vertebral body augmentation.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Lisa Peterson Abbott Spine, Inc. Regulatory Affairs Manager 5301 Riata Park Court, Building F Austin, Texas 78727

Re: K052638

Trade/Device Name: Spinnaker System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW, KIH Dated: September 19, 2005 Received: September 27, 2005

Dear Ms. Peterson:

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.

{3}------------------------------------------------

Page 2 -Lisa Peterson

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

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

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

KOS2638

Abbott Spine, Inc. Spinnaker System 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K05 2638

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.