The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

Device Description

The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft, is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 shaft lengths: 30 cm, 37 cm, and 44 cm.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "CoolSeal Trinity," an electrosurgical instrument. It details the device's indications for use, comparison to a predicate device, and performance data submitted to support its substantial equivalence.

However, the request asks for specific information regarding acceptance criteria and a study proving the device meets these criteria, particularly focusing on elements common in studies for AI/software-based medical devices (e.g., sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance).

Crucially, the provided document does NOT describe a study involving AI, machine learning, or software performance that would necessitate such detailed criteria or the specific study types listed in the prompt's requirements (e.g., sample sizes for training/test sets, expert ground truth for image data, MRMC studies, standalone algorithm performance).

The "performance data" mentioned in the document relates to:

Electrical and Thermal Testing: Verifying the device performs as expected when connected to a new compatible generator (Da Vinci E-200).
Ex-vivo Vessel Burst Pressure: Testing on excised fresh porcine blood vessels to demonstrate effective bipolar electrosurgical vessel sealing performance equivalent to the predicate device.

Therefore, many parts of your request about AI/software-specific study details cannot be answered from the provided text. The CoolSeal Trinity is a hardware electrosurgical instrument; the "study" described is a benchtop performance comparison to an existing predicate hardware device, not a clinical trial or AI model validation.

Based on the provided text, here is what can be inferred or stated regarding "acceptance criteria" and "study":

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device (CoolSeal™ Trinity K211579). This means demonstrating that the new device is as safe and effective as the predicate device and has the same technological characteristics. The only difference identified is the compatibility with a new electrosurgical generator (Da Vinci E-200).

The "study" described is a set of performance tests to support this substantial equivalence, particularly due to the identified difference.

Here's a breakdown based on your prompt, addressing what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics in the way one would for an AI/software device (e.g., "sensitivity > X%", "specificity > Y%"). Instead, the acceptance is qualitative: "performs as expected" and "effective...equivalent to the predicate device."

Acceptance Criteria (Implied for Substantial Equivalence due to change)	Reported Device Performance
Electrical and thermal performance with new compatible generator (Da Vinci E-200)	"Electrical and thermal testing verified that the proposed subject device performed as expected when connected to the E-200 generator."
Ex-vivo vessel sealing performance (e.g., burst pressure) equivalent to the predicate device	"Ex-vivo burst pressure testing of excised fresh porcine blood vessels was conducted on the subject device to demonstrate effective bipolar electrosurgical vessel sealing performance that is equivalent to the predicate device."
Overall safety and effectiveness compared to predicate device	"Based on a review of performance data, comparison of the device classification, intended use, operating principles, and technological characteristics, the subject device is safe, as effective, and performs as well as the legally marketed predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for either electrical/thermal testing or ex-vivo burst pressure testing. The term "excised fresh porcine blood vessels" implies biological material was used, but the quantity of vessels is not specified.
Data Provenance:
- Country of Origin: Not specified, but "porcine" suggests animal tissue.
- Retrospective or Prospective: These are laboratory benchtop tests, not clinical studies on human subjects, so the terms "retrospective" or "prospective" in the clinical sense don't strictly apply. The tests were likely conducted prospectively as part of the validation for the 510(k).

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

Not Applicable. This is a hardware device performance test, not an AI/software diagnostic accuracy study involving human expert interpretation for ground truth. The "ground truth" for electrical/thermal testing would be instrument readings against specifications, and for burst pressure, it would be measured burst pressure.

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

Not Applicable. See point 3.

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. This is not an AI/software device; therefore, no MRMC study or AI assistance evaluation would be relevant or performed.

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

Not Applicable. This is a hardware device. There is no "algorithm" or "standalone performance" in the sense of a software-based diagnostic tool. The performance measured is that of the physical device.

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

For Electrical/Thermal Testing: The "ground truth" would be established engineering specifications derived from the predicate device and general safety standards for electrosurgical equipment.
For Ex-vivo Vessel Burst Pressure: The "ground truth" is the empirically measured burst pressure of the sealed vessels, likely compared against a pre-defined threshold or against measurements from the predicate device under similar conditions. This is a direct physical measurement.

8. The sample size for the training set:

Not Applicable. This is not an AI/software device; there is no "training set."

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

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 15, 2023

Bolder Surgical, LLC Nicholas Wong Sr. Manager, Regulatory Affairs 331 S. 104th Street Suite 200 Louisville, Colorado 80027

Re: K231012

Trade/Device Name: CoolSeal Trinity Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 20, 2023 Received: October 24, 2023

Dear Nicholas Wong:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.11.15
13:42:02-05'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

See PRA Statement below.

510(k) Number (if known)

Device Name CoolSeal Trinity

Indications for Use (Describe)

The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesioly, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

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

SUBMITTER

Bolder Surgical, LLC. (now part of Hologic, Inc.) 331 S. 104th Street, Suite 200 Louisville, CO 80027

Phone: 720-287-7130 Fax: 720-287-7135

Contact Person: Nick Wong Sr. Manager, Regulatory Affairs

Date Prepared: April 5th, 2023

DEVICES

Trade Name / Model #:

CoolSealTM Trinity

. 30 cm / CSL-TR105-30
37 cm / CSL-TR105-37 ●
44 cm / CSL -TR105-44 .

Common or Usual Name:	Bipolar Vessel Sealing System
Classification Name:	Electrosurgical cutting and coagulation device and accessories
Regulatory Class:	II
Produce Code:	GEI

PREDICATE DEVICE

Trade Name: CoolSeal™ Trinity 510(k): K211579

DEVICE DESCRIPTION

CoolSeal™ Trinity:

INDICATIONS FOR USE

CoolSeal™ Trinity:

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The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to. Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Table 1 below compares technological characteristics between the subject and predicate devices. As Table 1 illustrates, all characteristics are the same, with the only difference being the identification of a new compatible electrosurgical generator.

Description	CoolSeal™ Trinity(Subject Device)	CoolSeal™ Trinity(Predicate - K211579)
Indications for Use	The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for usein minimally invasive or open surgical procedures where ligation and division ofvessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can beused on vessels (arteries, veins, and vascular bundles) up to and including 7 mmin diameter. It is indicated for use in general surgery procedures includingurologic, vascular, and gynecologic. It is indicated for use in adult and pediatricpopulations (infants, children, and adolescents). Procedures may include, but arenot limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis,hysterectomy, oophorectomy, etc.The CoolSeal™ Trinity has not been shown to be effective for tubal sterilizationor tubal coagulation for sterilization procedures. Do not use the CoolSeal™Trinity for these procedures.The device is contraindicated for use in ENT procedures.
Where used(environment)	Operating Room
Intended User	Surgeons
Anatomical Sites	Vessels, tissue bundles, and lymphatics
Anatomical Size	Arteries, veins, and vascular bundles up to and including 7 mm in diameter
Patient Population	Adult and pediatric populations (infants, children, and adolescents).
Power Source	Bipolar energy platform
CompatibleElectrosurgicalGenerator	CoolSeal GeneratorDa Vinci E-200	CoolSeal Generator
Primary Functions	Grasp, Dissect, Seal, Divide

Table 1. Presents the subject device compared to the predicate device.

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Description	CoolSeal™ Trinity(Subject Device)	CoolSeal™ Trinity(Predicate - K211579)
Mechanism ofGrasping	Hand actuated lever allows user to open or close
Mechanism ofDissection(Separation)	Bilateral jaw allows the user to separate planes of tissue
Mechanism ofAction (Sealing)	Seal is created by application of RF energy to structures interposed between thejaws of the instrument.
Seal Activation	Button on the sealer instrument handle activated by thumb
Knife Activation	Cutting trigger – non-energized
Automatic sealingcycle	Yes
Rated Voltage(Vpeak)	190 Vpeak
Shaft Diameter	5 mm
Shaft Length	30 cm, 37 cm, 44 cm
Shaft Rotation	>360°
Seal Length	19 mm
How Supplied	Single-use disposable
Tissue ContactMaterials	Stainless steel, titanium, polymers, silicone, polymer adhesives, and insulatingcoatings
Surgical Approach	Open or laparoscopic
Sterilization	Ethylene Oxide
Sterility AssuranceLevel	10-6

PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Electrical and Thermal Testing

Electrical and thermal testing verified that the proposed subject device performed as expected when connected to the E-200 generator.

Ex-vivo Vessel Burst Pressure

CoolSeal™ Trinity:

Ex-vivo burst pressure testing of excised fresh porcine blood vessels was conducted on the subject device to demonstrate effective bipolar electrosurgical vessel sealing performance that is equivalent to the predicate device.

CONCLUSIONS

Based on a review of performance data, comparison of the device classification, intended use, operating principles, and technological characteristics, the subject device is safe, as effective, and performs as well as the legally marketed predicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.