The Anspach Powered Kerrison System" (PKS) is indicated for use as an accessory attachment for I he rulisplay of the systems for cutting, shaping and removal of bone, including bones of the skull and spine.

Device Description

The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism. PKS consists of four basic component parts: Pistol Grip Trigger Assembly housing, Straight Nose-Tube Attachment, Shielded Attachments, Cutters.

AI/ML Overview

The provided text describes a medical device, the Anspach Powered Kerrison System (PKS), along with its design, materials, operation, indications, contraindications, cleaning/sterilization, warnings, cautions, and a comparison to predicate devices for demonstrating substantial equivalence. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone performance studies.

The document's primary purpose is to establish substantial equivalence for regulatory clearance (510(k) submission K022907), which relies on comparing the new device to existing legally marketed predicate devices rather than presenting novel performance acceptance criteria or a dedicated study for the new device's performance.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the PKS itself. The acceptance criteria for the 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices, focusing on design, materials, intended use, and safety similarities.
Reported Device Performance: No quantitative performance data for the PKS (e.g., cutting speed, precision, force exerted) is provided. The description mentions "quick and effectively cut away" bone, but this is qualitative.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document for the PKS's performance. The 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices.	The Anspach PKS "quickly and effectively cut away" bone. (Qualitative statement)
Materials recognized as safe for intended uses, contact, and duration.	Constructed of the same materials as other Anspach motors, nosepiece attachments, and cutters, recognized as safe for intended uses.
Sterilization effective.	Recommended sterilization by Steam Autoclave with specified parameters for cleaning and sterilization.
Indicated for cutting and shaping bone, including skull and spine.	"The Anspach PKS is indicated for cutting and shaping bone, including bones of the skull and spine."

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

Not provided. No test set or associated data is mentioned for proving device performance.

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)

Not provided. No ground truth establishment is described for a test set. This document relies on regulatory review and comparison to existing devices, not a clinical study with expert-adjudicated ground truth.

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

Not applicable. No test set or adjudication process is described.

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 device is a surgical tool, not an AI-assisted diagnostic tool or system that would typically undergo MRMC studies or involve human readers.

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

Not applicable. This device is a mechanical surgical tool, not an algorithm. Therefore, standalone performance in the context of AI is not relevant. The device operates with a human surgeon "in the loop."

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

Not applicable. The document does not describe a study involving a "ground truth" in the context of disease detection or diagnostic accuracy. The "ground truth" for this regulatory submission is essentially that the device is substantially equivalent to predicate devices based on its design, intended use, and operational characteristics, which have established safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is a mechanical surgical tool. There is no concept of a "training set" as would be used for machine learning or AI models.

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

Not applicable. As above, no training set or ground truth in that context.

Summary

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K022907

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510(k) SUMMARY: - Anspach Powered Kerrison System (PKS) Exhibit 07:

BACKGROUND:

Spine surgeons gain access to the posterior aspect of the spinal cord and its nerve roots by removing a portion of the vertebra called the laminectomy). The procedure is typically performed by using a manual "Kerrison" rongeur, powered rongeur or by some highly skilled surgeons using a high-speed drill (HSD) system with a long-straight or craniotome nosepiece attachment and burr (Anspach or similar). Powered, manual rongeurs and craniotome attachments have a footplate that is inserted between the bone of the lamina and the underlying nerve. The footplate helps to guide the blade and helps protect surrounding tissues. Once the footplate is under the surgeon squeezes the handle of the rongeur which advances the instrument's blade, bringing the cutting surface down to the footplate, biting off a small piece of the lamina.

DESIGN, MATERIALS AND OPERATION CHARACTERISTICS:

Design: The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism.

PKS consists of four basic component parts:

Pistol Grip Trigger Assembly housing મુ
彩 Straight Nose-Tube Attachment
- Shielded Attachments
- Cutters

Materials: PKS is constructed of the same materials that are used in construction of other Anspach motors, nosepiece attachments and cutters. There are no new or unusual materials used in construction of any of the system's component parts. System components that contact human tissues are constructed of materials recognized as safe for their intended uses, contact and duration.

Operation Characteristics: Surgeon simply removes the previous cutting burr and attachment being used and reassembles the motor with PKS in a quick, simple four-step process

01 Select and attach desired PKS straight nose-tube attachment to motor.
02 Insert through straight nose-tube attachment and lock the desired cutter.
03 Insert motor/nose-tube/cutter assembly through trigger housing assembly and lock into place.
04 Insert nose-tube/cutter assembly through burr-guard attachment and locked onto trigger assembly housing.

PKS is now assembled and ready to use. Note: Cutter tip is not extended and is in its retracted position inside straight nose-tube attachment. Surgeon places footplate of PKS burr guard between lamina and nerve (or other soft tissue or structure) and by gripping pistol-grip handle firmly, lightly squeezing the trigger to advance high-speed burr to the bone, which is quickly and effectively cut away. Releasing the trigger causes the high-speed burr to be retracted back into the straight nose-tube attachment, which can then be repositioned and the procedure repeated.

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INDICATIONS / CONTRAINDICATIONS:

Anspach PKS is indicated for cutting and shaping bone, including bones of the skull and spine. There are currently no, known specific contraindications with use of the device.

CLEANING/STERILIZATION/MAINTENANCE:

PKS cutters are single-use, disposable and cleaning, reprocessing and re-use are not recommended. Anspach cannot guarantee maximum cutter effectiveness after its use and/or 3rd party re-processors. To ensure maximum bone cutting performance, use of a new, previously unused cutter is strongly recommended for each patient/procedure.

The PKS Pistol-Grip Handle and straight nosepiece attachments are not designed to be immersed into any liquids during cleaning (Damage to high-speed bearings could result). Manual cleaning with mild soap and water is recommended with internal cleaning accomplished by an accessory cleaning brush (available from Anspach).

Sterilization of PKS is the same as with other Anspach motor and attachment system due to the similarity in materials, design complexity and materials. Recommended Sterilization is by Steam Autoclaye at the following processing parameters: NOTE: Cleaning, sterilization and storage conditions are specified on product package inserts available with every PKS component and within a variety of surgical equipment manuals.

Steam Autoclave/Gravity Air Displacement	270+/- 2° (F) [132 +/-1°(C)] for 20 minutes unwrapped
Steam Autoclave/High Speed vacuum	270+/- 2° (F) [132 +/-1°(C)] for 10 minutes wrapped or8 minutes unwrapped

WARNINGS:

Generic Warnings for use of Anspach Motor Systems, Attachments and Cutters are specified on product inserts and equipment manuals.

For safe and effective use of any Anspach product, it is strongly suggested that specialized training be undertaken since surgical techniques using Anspach products are highly specialized and complex procedures. Improper surgical technique or improper use of Anspach products can cause severe injury or death to a user or patient and cause severe damage to Anspach products and/or other manufacturer's or user facility's equipment.

CAUTIONS:

Generic cautions for use of Anspach Motor Systems, Attachments and Cutters are specified on product inserts and equipment manuals (See Section 14 and associated exhibits).

SUBSTANTIAL EQUIVALENCE:

The Anspach PKS is a rongeur, powered by a pneumatic (air/gas) or an electric motor currently manufactured and distributed by Anspach (K831756 - Black Max; K965080 - MicroMax and; K011444 - eMax). Anspach PKS is similar in appearance, materials and has the same intended uses as other powered rongeurs and the same intended uses as both powered and manual rongeurs. The

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foot-piece of the PKS shielded attachment is identical in materials and design to the foot-piece of other Anspach shielded attachments (K974025).

Principle difference between Anspach PKS and other rongeurs is that PKS uses a high-speed motor driven rotating burr to dissect bone instead of the straight, rigid blade system of other rongeurs. Difference between Anspach PKS and surgical techniques employing high-speed drill (HSD) systems is that PKS provides a long attachment (greater surgeon visibility) with an integral shielding feature identical to other Anspach Shielded Attachments.

	Principle Differences Between PredicateDevices/Methods and Anspach PKS	PoweredRongeur	ManualRongeur	HSDSystem	AnspachPKS
01	US Classification	II	I	II	II
02	EU Classification	Ila	I (?)	Ila	Ila
03	Manually Powered	No	Yes	No	Yes
04	Externally powered
	Gas/air	Yes	No	Yes	Yes
	Electric	(?)	No	Yes	Yes
05	Bone Cutting Mechanism
	Straight, rigid blade	Yes	Yes	No	Yes
	High-speed rotation	No	No	Yes	Yes
06	Activation Recoil	Yes	No	No	No
07	Indicated for Skull/Spine Procedures	Yes	Yes	Yes	Yes
08	Protection of Surrounding Tissues	Yes	Yes	Yes*	Yes
	* When used with a shielded attachment
09	Similarity in Materials	Yes	Yes	Yes	Yes
	* Patient contact components
10	Indicated for Spine/Skull Procedures	Yes	Yes	Yes	Yes
11	Reusable Device	Yes	Yes	Yes	Yes*
	* PKS Cutters are single-use, disposable devices
12	Cutting Blade Sharpness Assurance	None	None	Yes*	Yes*
	* All Anspach Cutters are single-use, disposable devices
13	Cleaning Immersable	No	(?)	No	No
14	Recommended Sterilization Method	Steam	Steam	Steam	Steam

End Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a human figure in profile, composed of three curved lines that resemble a bird in flight. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 2002

The Anspach Effort, Inc. William G. Conety Director, Regulatory Affairs 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K022907

Trade/Device Name: Anspach Powered Kerrison System (PKS) Regulation Number: 882.4845 Regulation Name: Powered rongeur Regulatory Class: Class II Product Code: HAD Dated: August 26, 2002 Received: September 3, 2002

Dear Mr. Conety:

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,

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Page 2 -- Mr. William G. Conety

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K () 2290.7

Page 1 of 1

Device Name: "Powered Kerrison System" (PKS)

INDICATIONS FOR USE:

DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K022907

_ OR Over-the-Counter Usc: ___________________________________________________________________________________________________________________________________________________ Prescription Use: V_ Per 21 CFR 801.109)

Regulation Number and Section

§ 882.4845 Powered rongeur.

(a)
Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).