The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. 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 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 does not describe acceptance criteria for a device, nor does it detail a study that proves a device meets specific acceptance criteria in the manner requested.

Instead, the document is a 510(k) Substantial Equivalence Determination letter from the FDA to Standard Bariatrics for their device, the "Standard Clamp." This letter affirms that the FDA has reviewed the company's premarket notification and determined the device is substantially equivalent to a legally marketed predicate device (the Doyen Atraumatic Bowel Clamp).

The "Performance Data" section of the document mentions some preclinical evaluations but does not provide the detailed information requested about acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.

Here's what can be extracted and what is missing, based on the provided text:

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

Not Available. The document does not specify quantitative acceptance criteria. It broadly states: "Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect." This is a qualitative statement, not a set of measurable criteria with reported results against them.

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

Not Available. The document only mentions "in vivo" evaluation and "histological assessment." It does not specify the number of samples (e.g., animals, tissue samples), the country of origin, or whether the study was retrospective or prospective.

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

Not Available. The document states a "histological assessment" was performed, implying a pathologist or similar expert would interpret the results, but it does not specify the number or qualifications of such experts.

4. Adjudication method for the test set

Not Available. No information is provided regarding adjudication methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not Available. No MRMC study is described. The comparison made is between the Standard Clamp's tissue effects and "other surgical devices including surgical staplers, soft tissue clamps, and graspers" and specifically the "Doyen clamp" in a histological assessment (tissue damage), not a human reader performance study.

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

Not Applicable. The device is a manual surgical instrument, not an AI algorithm. Therefore, "standalone" performance in the context of an AI algorithm is not relevant or described.

7. The type of ground truth used

Histological assessment (Pathology). The document states: "Tissue effects from the Standard Clamp were compared... in a histological assessment." This implies that the ground truth for "tissue effect" was determined by pathological examination of tissue samples.

8. The sample size for the training set

Not Applicable/Available. As this is a manual surgical instrument and not an AI/ML device, the concept of a "training set" is not relevant. No such data is provided for device development.

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

Not Applicable/Available. See #8.

In summary, the provided text confirms the FDA's marketing clearance based on substantial equivalence to a predicate device, and it briefly mentions preclinical testing related to tissue effects. However, it lacks the detailed methodology, acceptance criteria, and specific performance results typically found in a clinical study report for advanced medical devices, especially AI-driven ones.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 2, 2016

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

Re: K153358

Trade/Device Name: Standard Clamp Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class I Product Code: GDJ Dated: March 27, 2016 Received: April 4, 2016

Dear Ms. Alison 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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) K153358

Device Name Standard Clamp

Indications for Use (Describe)

The Standard Clamp is indicated for use in open 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 is a logo for Standard Bariatrics. The logo features a stylized red "S" on the left, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The "S" is made up of three horizontal lines, and 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 21 CFR 807.92.

Submitter Information
Applicant Name	Standard Bariatrics
Address	Standard Bariatrics4362 Glendale Milford RoadCincinnati, OH 45242 USA
Contact Person	Alison SatheRegulatory, Standard Bariatrics513-304-7971alison@standardbariatrics.com
Preparation Date	December 7, 2015
Device Information
Device Trade Name	Standard Clamp
Common Name	Manual Surgical Instrument
Classification Name	Manual surgical instrument for general use
Classification Panel	79 General and Plastic Surgery
Regulation	Class I per 32 CFR 878.4800, product code GDJ
Legally Marketed PredicateDevice(s)	Doyen Atraumatic Bowel Clamp
Product Code	SCR25
Reason for 510(k)	New Device
Device Description	The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. 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 end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
Intended Use	The Standard Clamp is a hand held device used 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 staplers during transection of tissue.
Indications for Use:	The Standard Clamp is indicated for use in open procedures to grasp, clamp and manipulate soft tissues

Technological Characteristics: The Standard Clamp is a non-energized, manually articulated, surgical 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. Technical specifications are as follows:

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Image /page/4/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" enclosed in a rounded square on the left. To the right of the symbol, the words "STANDARD" and "BARIATRICS" are written in bold, black capital letters, stacked vertically. A small trademark symbol appears next to the word "BARIATRICS".

Product	Standard Clamp	Doyen Atraumatic Bowel Clamp
Type of Device	Reusable	Reusable
Materials (endeffector)	Stainless Steel	Stainless Steel
Length	25.4 inches (64.5 cm)	9 inches
Weight	1.7 lbs.	unknown
ArticulationMechanism	Rotating knob on handle	none
Articulation	up to 55° from midline	Available in curved or straight configuration
End effector design	Stainless steel jaws with non-piercing ridges to	Stainless steel jaws with non-piercing ridges
	grasp tissue	to grasp tissue
End effector closure	Parallel closure	Scissor-type closure
Handle	In-line grip	In-line grip
Sterilization Method	Steam Sterilization	Steam Sterilization
Flush Port	Yes	No
Anatomical Site Used	Various soft tissues	Various soft tissues
Energy Delivered	No	No
Biocompatibility	Biocompatible for blood/bone/tissue contact	Biocompatible for blood/bone/tissue contact
	for limited duration	for limited duration

Performance Data:

Pre-clinical evaluation of the Standard Clamp was performed to ensure the device may be used as designed. The device ability to clamp the stomach was evaluated in vivo. Tissue effects from the Standard Clamp were compared to other surgical devices including surgical staplers, soft tissue clamps, and graspers in a histological assessment. The Standard Clamp demonstrated little or no tissue effect after being clamped on stomach for an extended period of time as observed under histology. The Standard Clamp exhibited less tissue damage compared to graspers and surgical staplers with the exception of the Doyen clamp which also demonstrated no damage to tissue. Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect.

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

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.