The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Standard Clamp." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML algorithm.

Therefore, many of the requested details about acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/ML are not available in this document.

However, I can extract the information related to the device's pre-clinical evaluation which serves as a form of performance data for this physical medical device.

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

The document does not provide a formal table of quantifiable acceptance criteria with corresponding performance metrics for the Standard Clamp. Instead, it describes a pre-clinical evaluation and its outcome.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Ability to clamp long planes of soft tissue without damage	"Testing demonstrated acceptable performance of the Standard Clamp." "No damage to surrounding tissues were caused by any of the clamps."
Histological tissue effects comparable to control/predicate devices	"The histology demonstrated similar types of tissue effects between the three clamps."
Conformance to device specifications	"The data demonstrate conformance to the device specifications."

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

Sample Size: Not explicitly stated as a number of animals or trials. The text mentions "a live anesthetized pig" (singular) and "the porcine stomach laparoscopically." It then refers to "histology samples... for each clamp," implying multiple clamping actions or multiple clamps tested on the same animal. The exact number of clamping instances or samples is not specified.
Data Provenance: Prospective, in-vivo animal study. The location (country of origin) is not specified, but the submission is to the U.S. FDA.

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

This information is not provided. The histological analysis would typically be performed by a veterinary pathologist, but their number and qualifications are not mentioned.

4. Adjudication method for the test set

Not applicable/not described. This was a direct observation and histological analysis, not a human reader study requiring adjudication.

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

No, an MRMC study was not done. This device is a surgical instrument, not an AI/ML diagnostic tool, so this type of study is not relevant.

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

Not applicable. This is a physical surgical instrument.

7. The type of ground truth used

The ground truth was established through:

In-vivo observation of tissue effects during and after clamping.
Histological analysis of resected stomach tissue after clamping.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2016

Standard Bariatrics Ms. Alison Sathe Director of Regulatory 4362 Glendale Milford Rd. Cincinnati, Ohio 45242

Re: K161720

Trade/Device Name: Standard Clamp Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 31, 2016 Received: September 6, 2016

Dear Ms. Sathe:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161720

Device Name Standard Clamp

Indications for Use (Describe)

The Standard Clamp is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The word "BARIATRICS" has a trademark symbol next to it.

510(K) Summary

This 510(K) Summary of safety and effectiveness for the Standard Clamp is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.

Applicant:	Standard Bariatrics
Address:	Standard Bariatrics4362 Glendale Milford RoadCincinnati, OH 45242 USA
Contact Person:	Alison SatheDirector of Regulatory Standard Bariatrics
Telephone/Email/Fax:	513-304-7971alison@standardbariatrics.com
Preparation Date:	June 16, 2016
Device Trade Name:	Standard Clamp
Common Name:	Laparoscopic Surgical Instrument
Classification Name:	Endoscope and accessories (GCJ, 21 CFR 876.1500)
Legally Marketed Predicate Device(s):	Standard Bariatrics Standard Clamp – K153358Aesculap Inc. Manual Laparoscopic Instruments – K944467

Device Description:

Intended Use:

The Standard Clamp is a hand held device used during laparoscopic surgery to clamp long planes of soft tissues. The device allows the surgeon to clamp and manipulate flat tissue and organs, such as the stomach. The clamp can also be used by the surgeon to help guide endoscopic staplers during resection of tissue.

Indication for Use:

The Standard Clamp is indicated for use in laparoscopic procedures to facilitate grasping, mobilization, and transection of tissue.

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Image /page/4/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a stylized red "S" on the left, followed by the words "STANDARD BARIATRICS" in black, block letters. The "S" is made up of three curved lines that form a square shape.

Technological Characteristics:

The Standard Clamp is a non-energized, manually articulated, laparoscopic clamp. The device is comprised of stainless steel and is validated for sterilization by steam autoclave. Two knobs on the device handle allow the user to adjust the angle of the end effector with respect to the shaft and open/close the jaws.

Table 1: Technological Characteristics

Product	Standard Clamp(proposed)	Standard Clamp(K153358)	Aesculap ManualLaparoscopic Instruments(K944467)
Type of Device	Reusable	Reusable	Reusable
Materials (end effector)	Stainless Steel	Stainless Steel	Stainless Steel
Length (Overall)	25.4 inches (64.5 cm)	25.4 inches (64.5 cm)	unknown
Length (end effector)	10.6 inches (27 cm)	10.6 inches (27 cm)	4 inches (10 cm)
Width of end effector	0.4 inches (1 cm)	0.4 inches (1 cm)	0.4 inches (1 cm)
Weight	1.7 lbs.	1.7 lbs.	1 lb.
Articulation Mechanism	Rotating knob on handle	Rotating knob on handle	Rotating knob on handle
Articulation	up to 55° from midline	up to 55° from midline	up to 45° from midline
End effector design	Stainless steel jaws withnon-piercing ridges tograsp tissue	Stainless steel jaws withnon-piercing ridges tograsp tissue	Stainless steel jawswithout ridges to grasptissue
End effector closure	Parallel closure	Parallel closure	Scissor-type closure
Handle	In-line grip	In-line grip	Pistol grip
Sterilization Method	Steam Sterilization	Steam Sterilization	Steam Sterilization
Flush Port?	Yes	Yes	Unknown
Anatomical Site Used	Various soft tissuesaccessible duringlaparoscopic procedures	Various soft tissuesaccessible during openprocedures	Various soft tissuesaccessible duringlaparoscopic procedures
Types of procedures	Laparoscopic procedures	Open procedures	Laparoscopic procedures
Energy Delivered?	No	No	No

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Image /page/5/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a red square with a stylized white "S" inside. To the right of the square is the company name, "STANDARD BARIATRICS," in bold, black letters. The trademark symbol is located to the right of the company name.

Compatible with 12 mmtrocar?	Yes	Yes	Yes
Biocompatibility	Biocompatible forblood/bone/tissuecontact for limitedduration	Biocompatible forblood/bone/tissuecontact for limitedduration	Biocompatible forblood/bone/tissuecontact for limitedduration

Performance Data:

Pre-clinical evaluation of the device was performed to ensure the device may be used as designed. The Standard Clamp was used in a live anesthetized pig to evaluate the ability to clamp on tissue without damaging tissue as compared to other laparoscopic graspers and clamps were placed on the porcine stomach laparoscopically. Tissue effects were observed in vivo during clamping and after release. After clamping, the stomach was resected and histology samples were analyzed for each clamp.

Testing demonstrated acceptable performance of the Standard Clamp. No damage to surrounding tissues were caused by any of the clamps. There histology demonstrated similar types of tissue effects between the three clamps. The data demonstrate conformance to the device specifications.

Substantial Equivalence:

The Standard Clamp has the same indications, technological characteristics, principles of operation as its predicate devices. There are no new issues of safety or effectiveness. Thus, the Standard Clamp is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.