The Titan SGS with implantable staples (Titan Stapler) is a single patient use, sterile instrument used for cutting and stapling gastric tissue for sleeve gastrectomy pouch creation. The Titan Stapler is supplied preloaded with staples, fires once and cannot be reloaded. The Titan Stapler is comprised of three main sections: Stapler, Cable, and Power Supply Unit. The stapler end effector is 230 mm long and contains 342 staples that are organized in 6 staggered rows, 3 on each side of the cut line. The staples range in closed staple height from 2.2 mm to 1.2 mm. Staples are formed into a traditional 'B' shape: similar to existing devices. As with other powered staylers, the Titan Stapler opens and closes through a simple mechanical linkage housed in the shaft and effector of the device. The device of the single-use Titan Stapler and a reusable power source which is supplied separately. There are no accessories supplied with the instrument. The Titan Stapler Power Source is designed to supply energy to the Titan Stapler and has a unique receptable port specific to the Titan Stapler.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Titan SGS linear cutter. However, it does not contain the specific acceptance criteria and detailed study information requested in your prompt regarding device performance metrics like accuracy, sensitivity, or specificity.

The document focuses on demonstrating substantial equivalence to a predicate device (Echelon Flex Powered Plus) rather than proving the device meets specific performance criteria against a predefined ground truth in the way one might for an AI/ML diagnostic device.

Here's a breakdown of what is available and what is missing based on your request:

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

This information is not explicitly provided in the document in the format of specific acceptance criteria (e.g., minimum accuracy of X%, sensitivity of Y%). The document states:

"Pre-determined performance specifications were tested, and validation activities were conducted to demonstrate that the Titan Stapler met the defined criteria."
"The Titan Stapler met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use."

However, the specific quantitative acceptance criteria and the corresponding reported performance values (e.g., specific measurements of staple line integrity, leak rates, etc.) are not detailed. It mentions "hemostasis as compared to the predicate device" in animal studies, but no numerical data.

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

Clinical Study: "A comparative clinical study including 36 subjects at one site was conducted between the Titan Stapler and the predicate device, the Echelon Flex Powered Plus GST System on excised human stomach." This implies a prospective study using ex vivo human stomach tissue. The country of origin is not specified but given the FDA context, it's likely the US.
IDE Study: "The study enrolled 62 subjects at three sites." This was a prospective study (IDE G200085). Country of origin is not specified, but again, likely the US.

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)

This information is not provided. The assessment of "comparable performance" in the clinical studies would have involved expert evaluation (e.g., surgeons assessing the staple line), but the number and qualifications of these experts are not detailed.

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

This information is not provided.

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

There is no mention of an MRMC study or AI assistance. This device is a surgical stapler, not an AI/ML diagnostic tool.

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

This is not applicable as it's a physical medical device (surgical stapler), not an algorithm.

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

For the "clinical study (36 subjects) on excised human stomach," the ground truth would likely involve direct visual and physical assessment by surgical experts regarding the quality of the stapled tissue (e.g., staple formation, integrity, transection line).

For the "IDE G200085 study (62 subjects)" which demonstrated "reasonable assurance of safety and effectiveness," the ground truth would typically involve a combination of:

Clinical outcomes data: monitoring for adverse events (e.g., leaks, bleeding, stricture formation) specific to the stapler performance.
Intraoperative and postoperative assessments: by surgeons and medical staff.

8. The sample size for the training set

This is not an AI/ML device, so there is no "training set" in the context of an algorithm. The development of the device would involve engineering design, bench testing prototypes, and animal studies before human studies.

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

Not applicable as it's not an AI/ML device.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a surgical stapler, focusing on demonstrating substantial equivalence to a predicate device. It does not provide the kind of detailed performance metrics, acceptance criteria, and AI/ML specific study information you requested, as those types of studies and criteria are typically associated with diagnostic AI/ML products.

Summary

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April 28, 2021

Standard Bariatrics Alison Sathe Regulatory Affairs 4362 Glendale Milford Rd. Cincinnati, Ohio 45242

Re: K210278

Trade/Device Name: Titan SGS Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: January 28, 2021 Received: February 1, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210278

Device Name Titan SGS

Indications for Use (Describe)

The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectory pouch creation.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. Submitter's Information

Company Name:	Standard Bariatrics, Inc.
Address:	4362 Glendale Milford RoadCincinnati, OH 45242
Phone Number:	513-658-0328
Fax Number:	513-436-0201
Contact Person:	Alison Sathe
Phone Number:	513-304-7971
Email Address:	alison@regulatorymark.com
Date Prepared:	January 28, 2021

II. Device Information

Device Name:	Titan SGS
Common Name:	Staple, Implantable
Regulatory Class:	Class II
Regulation:	21 CFR 878.4750
Product Code:	GDW

III. Predicate Device:

Echelon Flex Power Plus, K140560, 21CFR 878.4750, Class II, Product Code GDW Ethicon Endo-Surgery, LLC

IV. Device Description

The Titan Stapler is comprised of three main sections:

. Stapler: located in the sterile field, it has three main sections
- the handle, which does not contact the patient and is handled by user within the sterile O field,
- the device shaft and end effector which are surgically invasive components, O
- the staples, which are housed in the end effector until they are applied to the tissue O where they are permanently implanted.
. Cable: permanently attached to the stapler, it is passed from the sterile field to the nonsterile area to connect with the reusable Power Supply Unit, and

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. Power Supply Unit: which is stored and used in the nonsterile area of the O.R. and powers the stapler opening, closure, and firing
The stapler end effector is 230 mm long and contains 342 staples that are organized in 6 staggered rows, 3 on each side of the cut line. The staples range in closed staple height from 2.2 mm to 1.2 mm. Staples are formed into a traditional 'B' shape: similar to existing devices. As with other powered staylers, the Titan Stapler opens and closes through a simple mechanical linkage housed in the shaft and effector of the device.

The device of the single-use Titan Stapler and a reusable power source which is supplied separately. There are no accessories supplied with the instrument. The Titan Stapler Power Source is designed to supply energy to the Titan Stapler and has a unique receptable port specific to the Titan Stapler.

V. Intended Use

Intended for transection and resection of gastric tissue.

VI. Indications for Use

The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectomy pouch creation.

VII. Technological Characteristics

The technological specifications of Titan Stapler and its predicate have been evaluated to determine equivalence. As detailed on Section 012 - Substantial equivalence of this 510(k) submission, upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Titan Stapler is determined by Standard Bariatrics to be substantially equivalent to existing legally marketed devices (Table 1).

	Standard Bariatrics'Device	Predicate Device	Determination
Product Name	Titan SGS	Echelon Flex Powered Plus	N/A
510(k) Holder	Standard Bariatrics	Ethicon Endo-Surgery, LLC	N/A
Regulatory Information
510(k) Number	TBD	K140560	N/A
Product Code	GDW	GDW	Same
Regulation	21 CFR 878.4750Implantable Staple	21 CFR 878.4750Implantable Staple	Same
Classification	II	II	Same
Design Information
Principle of operation	Tissue is placed betweenjaws of stapler, jaws areclosed, stapler is fired bydepressing trigger, knifetransects tissue as staplesare formed in tissue	Tissue is placed between jaws ofstapler, jaws are closed, stapleris fired by depressing trigger,knife transects tissue as staplesare formed in tissue	Same

Table 1: Overview of Substantial Equivalence
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Method of Insertion	Used in laparoscopicapplications by insertionthrough a trocar	Used in laparoscopicapplications by insertionthrough a trocar	Same
Power Source	DC powered - wall outlet	DC powered - battery	Equivalent
Staple Shape	B	B	Same
Staple Material	Titanium	Titanium Alloy	Equivalent.
Closed Staple Height	1.2 - 2.2	1.0-2.3mm	Equivalent
Staple Arrangement	3 staggered rows on eachside of cut line	3 staggered rows on each side ofcut line	Same
Staple Line ExtensionPast Cut Line	1.5 staples (6.0 mm)	1.5 staples (6.0 mm)	Same
Method of Resection	Blade	Blade	Same
Method of Activation	Trigger to open/closedevice jaws and fire	Trigger to open/close devicejaws and fire	Same
Sterilization	Provided sterile via gamma.10-6 SAL	Provided sterile via gamma. 10-6SAL	Same

The technological differences between the predicate and subject device do not impact the safety and effectiveness of the subject device as described in Section 012 - Substantial Equivalence.

VIII. Performance Data

Non-Clinical

Performance Testing to evaluate and compare the technological and performance characteristics included bench, animal, and clinical studies.

Pre-determined performance specifications were tested, and validation activites were conducted to demonstrate that the Titan Stapler met the defined criteria. Testing on the subject device included biocompatibility, MR compatibility, usability, Electrical Safety and EMC testing. Animal studies evaluating hemostasis as compared to the predicate device and a survival study were conducted.

Performance evaluation of the Titan Stapler during the design validation and verification was completed by applying methods of internationally recognized standards such as, EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process, EN ISO 14971:2012, Medical Devices - Application of Risk Management to Medical Devices, IEC 60601-1:2005/(R)2012, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, ISO 11737-2:2009, Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, among others.

The Titan Stapler met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use.

Clinical

A comparative clinical study including 36 subjects at one site was conducted between the Titan Stapler and the predicate device, the Echelon Flex Powered Plus GST System on excised human stomach. Results demonstrated substantially equivalent performance between the two devices for the equivalent indications for use.

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IDE G200085 with protocol title Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection was developed based on FDA's recommendations (Q200176). The study enrolled 62 subjects at three sites. Results demonstrated that the Titan SGS does not raise any new types of questions and the performance data provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.

IX. Conclusion

The Titan Stapler has the same intended use as the Echelon Flex Powered Plus GST System. The conclusion drawn from the nonclinical and clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. The design/technological differences do not raise any new types of questions and the performance data provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.

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.