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The SurgASSIST™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Device Description

The SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm is a cutter/stapler component addition to a previously cleared device, K012809, SuraASSIST™ System Right Angle Linear Cutter - 45mm Digital Loading Unit™. This Notification offers an additional style of cutting/stapling configuration, specifically, Straight Linear Cutters/staplers, both Blue and Green, of 55mm and 30mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Straight Linear Cutters are utilizing the identical technology and system approach which the previously cleared device currently utilizes.

The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809.

A steerable FlexShaft that serves as the interface between the . Digital Loading Unit™ (DLU) and the Power Console and provides the means of insertion of the DLU. The FlexShaft is steerable for surgical positioning of the DLU for access and visualization.
. A hand held Remote Control Unit that contains pushbuttons that actuate steering, extension and retraction of the anvil, stapling, and cutting.
Straight Linear Cutter Digital Loading Unit™ (DLU) that . contain implantable staples that form in a double staggered linear row of staples and a steel knife blade which transects the tissue between the two rows of formed staples. The Straight Linear Cutter DLU is offered currently in a 55mm and 30mm length size, in reloadable configuration.

AI/ML Overview

This 510(k) submission (K020719) for the SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU) does not contain detailed acceptance criteria or a study that proves the device meets specific performance metrics in the way modern AI/ML device submissions typically do.

The submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval (PMA). The primary evidence presented is a comparison of technological features and indications for use, rather than a quantifiable performance study against acceptance criteria.

Therefore, many of the requested sections (e.g., sample size for test set, expert qualifications, effect size of AI assistance, training set details) are not applicable or n/a as they relate to a different type of regulatory submission framework, specifically for AI/ML devices with performance metrics, which this 2002 submission is not.

Here's a breakdown based on the provided document:

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

Acceptance Criteria	Reported Device Performance	Comments
Safety and Effectiveness	The device is deemed "substantially equivalent" to legally marketed predicate devices, implying it meets the same safety and effectiveness standards.	The submission relies on demonstrating similarity to predicate devices rather than novel performance criteria.
Technological Features	"The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809."	This is the primary method of demonstrating equivalence. Specific performance metrics (e.g., staple formation strength, cutting efficiency) are not explicitly stated as numerical acceptance criteria or reported values in this summary.
Indications for Use	"The SurgASSIST™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses."	These indications are aligned with the predicate devices. There are no specific performance thresholds tied to these indications within this document.
Compliance with General Controls	The FDA states: "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."	This is a regulatory acceptance, not a performance metric.

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

Sample Size: Not applicable (n/a). The document does not describe a performance study with a test set of data points in the context of AI/ML or statistical clinical trials. The evaluation is based on device design comparison to predicates.
Data Provenance: Not applicable (n/a).

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

Not applicable (n/a). Ground truth establishment for a test set of data is not described in this type of submission.

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

Not applicable (n/a).

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 (n/a). This device is a surgical stapler, not an AI-assisted diagnostic or interpretative tool.

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

Not applicable (n/a). The device is a mechanical surgical instrument.

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

Not applicable (n/a), in the context of data for an AI/ML device. The "ground truth" for this device's safety and effectiveness is implicitly established by the long-standing use and regulatory clearance of its predicate devices, which are also mechanical stapling instruments.

8. The sample size for the training set

Not applicable (n/a). This device does not involve a "training set" in the sense of machine learning.

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

Not applicable (n/a).

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K Number

K020343

Device Name

SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL

Manufacturer

POWER MEDICAL INTERVENTIONS, INC.

Date Cleared

2002-04-10

(68 days)

Product Code

GDW

Regulation Number

878.4750

Type

Special

Panel

General & Plastic Surgery

Reference & Predicate Devices

K000908,K003277,K012809

Intended Use

The SurgASSIST™ System with Circular Stapler DLU, has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.

The SurgASSIST™ System with Right Angle Cutter Digital Loading Unit has applications in gastrointestinal, gynecological, surgical procedures for resection, transection, and creation of anastomosis.

Device Description

The SurgASSIST™ Wireless Remote Control Unit is a battery powered, hand held device that transmits control commands to the SurgASSIST™ System Power Console (PC).

The existing wired Remote control version will remain as a component of the SurgASSIST System. The wireless version of the Remote Control will be commercialized in addition to the existing wired version, and sold as an accessory to the System.

A battery capable of supplying power throughout the predictive life of the Remote Control Unit is permanently installed inside the hermetically sealed case or housing. All Wireless Remote Control Units share identical transmittance frequencies, however each Unit is preprogrammed with a unique identification code. When the Wireless Remote Control Unit is used to poweron the SurgASSIST™ Power Console (PC), this unique identification code is read and stored by the Console. The Power Console, with the stored identification code will then only respond to commands sent by its corresponding Remote Control Unit.

The radio frequency commands sent via the hand-held Remote Control Unit are Not considered Wireless Medical Telemetry, as defined by FCC. The frequencies assigned to the transmitter will not be in Medical Telemetry MHz bands set aside by the Wireless Medical Telemetry Service (WMTS).

AI/ML Overview

The provided text does not contain information regarding quantitative acceptance criteria or a study that proves the device meets such criteria for the SurgASSIST™ System with Wireless Remote Control.

The document is a Special 510(k) Device Modification PreMarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a clinical or bench study with acceptance criteria.

The information primarily discusses:

Device Description: The SurgASSIST™ Wireless Remote Control Unit is a battery-powered, handheld device that transmits control commands to the SurgASSIST™ System Power Console.
Predicate Devices: It lists existing wired SurgASSIST™ systems (K003277, K012809) and a Skylight Imaging System (K000908) for comparison.
Indications for Use: The system is intended for use throughout the alimentary tract for anastomosis and in gastrointestinal, gynecological, and thoracic surgical procedures for resection, transection, and creation of anastomosis. The indications for use are stated to be substantially identical to the predicate devices.
Comparison to Predicate Devices: A table compares features like intended use, FDA class, human factors, size, materials, command buttons, transmitter/receiver, power, software, and sterilization methods. The primary modification highlighted is the wireless capability.
FDA Clearance: The letter from the FDA confirms substantial equivalence based on the provided information.

Therefore, I cannot provide the requested details because the document does not include:

A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., latency, signal range, battery life duration targets) are mentioned, nor are results of tests against such criteria.
Sample size, data provenance: No test set or study is described.
Number of experts, qualifications, adjudication method: No expert review or ground truth establishment relevant to performance testing is mentioned.
MRMC comparative effectiveness study: This type of study is not mentioned as the device is a control unit for a surgical stapling system, not an imaging AI.
Standalone performance: No standalone performance metrics are provided beyond the device description of its function.
Type of ground truth used: Not applicable as no study with ground truth is described.
Sample size for training set: Not applicable; the document describes a hardware modification, not an AI or software device that would typically have a training set in this context.
How ground truth for training set was established: Not applicable.