The Endoscopic Insufflation Unit model XECR-2 is used to distend the gastrointestinal tract to optimize endoscopic observation utilizing carbon dioxide gas. The XECR-2 can be connected to both a CO2 cylinder and the medical facilities gas pipeline facility.

AI/ML Overview

The provided text is a 510(k) summary for the Olympus Endoscopic Insufflation Unit model XECR-2. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is important to note that a 510(k) submission for a device like an insufflation unit typically relies on bench testing, performance testing to established standards, and a comparison of technological characteristics to a predicate device, rather than clinical studies with human participants that measure diagnostic performance metrics (like accuracy, sensitivity, specificity, etc., which are common for AI/diagnostic software).

Therefore, many of the requested categories related to clinical study design, expert review, and ground truth will not be applicable or present in this type of submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative "acceptance criteria" in the format of a table with numerical thresholds for accuracy, sensitivity, or specificity, which are common for diagnostic or AI-driven devices. Instead, the "acceptance criteria" for this device's approval appear to be related to demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards.

The document states:

"The Endoscopic Insufflation Unit model XECR-2 is basically identical to the predicate devices in intended use, and similar in specifications except for the addition of new functions such as a timer."
"The clinical literature provided in this submission support the safety and efficacy of the subject device." (Note: this refers to existing literature about insufflation, not necessarily a new study specifically for the XECR-2 establishing new safety/efficacy metrics).
"When compared to the predicate devices, the XECR-2 insufflation unit does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."

Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Implied)
Intended Use	Identical to predicate devices	Identical to predicate devices
Safety	No significant changes affecting safety compared to predicates; supported by clinical literature	Safe as per predicate devices and general clinical understanding of insufflation
Effectiveness	No significant changes affecting effectiveness compared to predicates; supported by clinical literature	Effective as per predicate devices and general clinical understanding of insufflation
Specifications	Similar to predicate devices (e.g., CO2 gas delivery, water feeding capability)	Similar to predicate devices, with added functions like a timer
Method of Operation	No significant changes compared to predicate devices	Similar to predicate devices
Material/Design	No significant changes compared to predicate devices	Similar to predicate devices

Study Details (Where Applicable)

Sample size used for the test set and the data provenance:
- Not Applicable in the traditional sense of a clinical test set for AI/diagnostic performance. The approval is based on a comparison to predicate devices and general clinical literature supporting the technology, not a specific clinical study with a "test set" of patients for diagnostic performance evaluation of this specific insufflator.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of diagnostic performance, is not established for this type of device in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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 an endoscopic insufflation unit, not a diagnostic AI system or an imaging AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device (hardware) for insufflation, not a standalone algorithm. Its function is to facilitate endoscopic procedures, not to provide diagnostic interpretations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for its approval is its demonstrated technical performance and substantial equivalence to existing (predicate) devices, which are accepted as safe and effective.
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable.

Summary

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K 063786

510(k) SUMMARY

Endoscopic Insufflation Unit model XECR-2

2006/10/**

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1__General Information

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507Establishment Registration No: 8010047
Official Correspondent:	Laura Storms-TylerExecutive DirectorRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5688FAX: 484-896-7128Email:Laura.storms-tyler@olympus.comEstablishment Registration No: 2429304
Manufacturer:	Shirakawa Olympus Co., Ltd.3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,Nishishirakawa-gun, Fukushima, JAPAN 961-8061Establishment Registration No: 3002808148

2 Device Identification

Device Trade Name:	Endoscopic Insufflation Unit model XECR-2
Common Name:	Endoscopic Insufflator
Regulation Number:	21 CFR No. 876.1500
Regulation Name:	Endoscope and accessories
Regulatory Class:	II
Classification Panel:	Gastroenterology and urology
Product Code:	FCX and KOG

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K063786
Vg 2 "7"2

Predicate Device Information 3

Device Name	Olympus-Keymed Endoscopic CO₂ Regulator, Model ECR	E-Z-EM Endoscopic CO₂ Regulator
Common Name	Endoscopic Insufflator	Endoscopic Insufflator
Manufacturer	KeyMed, Ltd.	E-Z-EM, Inc.
510(k) No.	K881004	K053008

4 Device Description

5 Indications for Use

This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO2 gas and water feeding.

6 Comparison of Technological Characteristics

The Endoscopic Insufflation Unit model XECR-2 is basically identical to the predicate devices in intended use, and similar in specifications except for the addition of new functions such as a timer. The clinical literature provided in this submission support the safety and efficacy of the subject device.

7 Conclusion

When compared to the predicate devices, the XECR-2 insufflation unit does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K063786

Trade/Device Name: Endoscopic Insufflation Unit model XECR-2 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: December 19, 2006 Received: December 26, 2006

Dear Ms. Storms-Tyler:

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.

MAR 0 5 2007

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Ko63786 510(k) Number (if known): Device Name: Endoscopic Insufflation Unit model XECR-2 Indications For Use:

This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO2 gas and water feeding.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive. Abdomin and Radiological Devices 510(k) Number

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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.