The Power Extenders have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

Device Description

The Power Extenders are components of the SuraASSIST® System. A hand-held medical instrument, which connects the FlexShaft and Digital Loading Units® (DLUs) providing rigid capability, longitudinal positioning and mechanical interface of the DLU during surgical procedures. Power Extenders serve as a conduit between the DLUs and the Power Console. They obtain the mechanical and electrical power from the PC100 via the FlexShaft. Internally, the instrument contains drive-shafts that couple with the driveshafts in the FlexShaft. Rotary motion provided by the motors (located in the PC100) is delivered to the instrument through these drive shafts for various purposes such as clamping tissue or forming staples with attached DLUs.

AI/ML Overview

The provided document is a 510(k) summary for the Power Extenders device, which are components of a surgical stapler system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting the results of a standalone study with acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and expert involvement are not applicable or provided in this type of regulatory submission. This document is a regulatory filing for a Class II medical device (surgical stapler component), not a research study report.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/provided in this document.
The 510(k) submission states that "The Power Extenders used with the predicate Power Linear Cutter Reusable Digital Loading Unit®, cuts and staples identically to the predicate device (K052415)." This implies that the performance criteria are met by virtue of being functionally identical to an already cleared device. Performance data, if any, would be part of a separate technical report submitted to the FDA and not typically included in the public 510(k) summary in this level of detail.

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

Not applicable/provided.
This document does not describe a separate experimental "test set" in the context of typical AI/software performance studies. The core of this 510(k) is a comparison to a predicate device.

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

Not applicable/provided.
Ground truth establishment is not relevant for this type of device and regulatory pathway. The device's function (cutting and stapling) is mechanical, and its equivalence is demonstrated through comparative analysis with a predicate device, likely involving engineering testing and design comparisons, not expert-adjudicated datasets.

4. Adjudication Method for the Test Set

Not applicable/provided.
Adjudication methods are typically relevant for complex interpretative tasks, often in image analysis or diagnostic AI. This device is a surgical instrument component.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No, a MRMC study was NOT done.
This type of study is specifically for evaluating the impact of AI on human interpretation or decision-making. The Power Extenders are mechanical components of a surgical stapler and do not involve human "readers" or AI assistance in this context.

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

Not applicable.
This device does not contain an "algorithm" in the sense of AI or software for interpretation that would have standalone performance. Its function is mechanical.

7. The Type of Ground Truth Used

Not applicable/provided.
As this is a mechanical surgical device and not an interpretive AI system, the concept of "ground truth" (e.g., pathology, outcomes data) as it pertains to diagnostic or prognostic accuracy is not relevant here. The "truth" in this context would relate to engineering specifications, material properties, and functional performance matching the predicate device.

8. The Sample Size for the Training Set

Not applicable/provided.
This document describes a medical device, not an AI or machine learning model that would require a "training set."

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

Not applicable/provided.
As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant in this context.

Summary

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SECTION E - Special 510(k) Summary

Ko63746

In Accordance with 21 CFR Section 807.92 Power Medical Interventions® is submitting the following safety and effectiveness summary.

1. Submitter Information:
  Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 267-775-8151 Ph 267-775-8123 Fax

JAN 1 2 2007

Applicant:

Barbara J. Whitman

Date of Notification: December 14, 2006

1. Name of Device:

Trade Name:	Power Extenders
Common Name:	Surgical Staplers with Implantable Staples
Classification Name:	Staple, Implantable, GDW

1. Predicate Devices:
  SurgASSIST® ,Power Linear Cutter Reusable Digital Loading Units®, Power Medical Interventions, Inc., K052415.
1. Device Description
  The Power Extenders are components of the SuraASSIST® System. A hand-held medical instrument, which connects the FlexShaft and Digital Loading Units® (DLUs) providing rigid capability, longitudinal positioning and mechanical interface of the DLU during surgical procedures.
1. Device Modification
  Power Extenders used with the predicate Power Linear Cutter Reusable Digital Loading Unit®, cuts and staples identically to the predicate device (K052415). Power Extenders serve as a conduit between the DLUs and the Power Console. They obtain the mechanical and electrical power from the

000013

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K063746
page 2 of 2

PC100 via the FlexShaft. Internally, the instrument contains drive-shafts that couple with the driveshafts in the FlexShaft. Rotary motion provided by the motors (located in the PC100) is delivered to the instrument through these drive shafts for various purposes such as clamping tissue or forming staples with attached DLUs. The Power Extenders, once cleared to market, will enable the use of all of Power Medical Digital Loading Units®.

1. Indications For Use
  The Power Extenders have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
1. Comparison to Predicate Devices
  The Power Extenders have the same indications for use and the same functions as the previously cleared predicate Power Linear Cutter Reusable Diaital Loading Units® (K052415). The Power Extenders used in conjunction with the Power Linear Cutter Reusable Digital Loading Units® deliver two staggered rows of titanium staples on each side of a transection. For further details, please see the Predicate Comparison Chart in Section J of this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Power Medical Interventions, Inc. % Ms. Barbara J. Whitman Regulatory Affairs Manager 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047

JAN 1 2 2007

Re: K063746

Trade/Device Name: Power Extenders Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: December 8, 2006 Received: December 18, 2006

Dear Ms. Whitman:

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 - Ms. Barbara J. Whitman

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) 276-0115 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Aouliaque Buell MD

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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SECTION D

Indications for Use

510(k) Number (if known): _ K 0 6 37 4 6

Device Name: Power Extenders

Indications for Use:

Note: The Indications For Use for the Power Extenders are identical to that of the predicate device ,Power Linear Cutter Reusable Digital Loading Units®, which were cleared to market via 510/k) #K052415.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Ge and Neurological

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510(k) Number

000012

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.