The Kronner Low Profile Scope Holder is used to hold rigid endoscopes during endoscopic surgery and to allow rapid position changes by the pressing of a control button by the operator.
KLH-100 Kronner Low Profile Scope Holder For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
HPL-2-30 High pressure flexible gas line set, double output For abdominal, thoracic, arthroscopic endoscopic surgical procedures.
HPL-3-30 High pressure flexible gas line set, triple output For nasal endoscopic surgical procedures.
KLH-200 Arm assembly For abdominal, thoractic, arthroscopic and nasal" endoscopic surgical procedures. *requires the Small Endoscope Accessory
C-100 Arm assembly For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
C-101 Control strap, replacement For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
SG-101 Scope grip strap, replacement For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
SMA-100 Small Endoscope Accessory For nasal endoscopic surgical procedures

Device Description

The Kronner Low Profile Scope Holder consists of mechanical linkages that connect between the operating table side rail and the shaft or head of a rigid endoscope. A telescoping arm distinguishes the device from other endoscope holders. Inert nitrogen gas at 100-150 psi is used to provide the energy to multiple joints to lock the holder in position when a control button is released by the operator.

AI/ML Overview

The provided text describes a 510(k) submission for the "Kronner Low Profile Scope Holder," a medical device designed to hold rigid endoscopes during surgery. However, the document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, expert involvement, or ground truth establishment.

The document is a regulatory submission for substantial equivalence to a predicate device (Leonard Arm, K951854). It focuses on describing the device, its intended use, and comparing its technological characteristics to the predicate device. The FDA's response confirms substantial equivalence, allowing the device to be marketed, but this process does not inherently involve detailed performance studies against explicitly stated acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: No such criteria or performance data are provided.
Sample sized used for the test set and the data provenance: No test set is described or analyzed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is mentioned.
Adjudication method for the test set: No test set is described.
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: This device is a mechanical endoscope holder, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As above, this is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned in the context of device performance.
The sample size for the training set: No training set is relevant or mentioned for this type of mechanical device.
How the ground truth for the training set was established: No training set or ground truth is mentioned.

In summary, the provided 510(k) summary document focuses on demonstrating substantial equivalence to a predicate device and does not include the type of detailed performance criteria, study design, and results typically found for AI/software devices or clinical studies that would generate the information you requested.

Summary

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JAN | 2 |998

11-97 3543

510(K) SUMMARY

as required by 807.92(c)

: ਹੋੜਾ

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KRONNER PROTOTYPES, INC.

1443 Upper Cleveland Rapids Road Roseburg, Oregon 97470 Phone: (541) 672-2543 FAX: (541) 672-1074 E-mail: kronner@rosenet.net .

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Prepared: September 8, 1997

Contact Person: Crystal Kronner, Secretary

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Trade Name: Kronner Low Profile Scope Holder

Common Name: Endoscope Holder

Classification Name: Endoscope holding device, (no industry name for this device)

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Equivalent to legally marketed devices

· :: :: :

જ

का प

( K951854 ) Leonard Arm

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Description:

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Intended Usage:

The Kronner Low Profile Scope Holder is used to hold rigid endoscopes during endoscopic surgery and to allow rapid position changes by the pressing of a control button by the operator.

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Summary of technological characteristics of device compared to predicate devices.

The Kronner Low Profile Scope Holder is essentially equivalent to the Leonard Arm, except that it has a telescoping arm instead of an arm with a hinge joint, and uses nitrogen gas pressure as an energy source to hold position rather than vacuum.

The Kronner Low Profile Scope Holder uses flexible lines and a control which can be attached to the camera to supply and control the energy used to lock the joints. These features are built into the Leonard Arm.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1998

Ms. Crystal Kronner *Secretary Kronner Prototypes, Incorporated 1443 Upper Cleveland Rapids Road Roseburg, Oregon 97470

Re: K973543

Trade Name: Kronner Low Profile Scope Holder Regulatory Class: II Product Code: GCJ Dated: December 11, 1997 Received: December 29, 1997

Dear Ms. Kronner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System -Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Ms. Kronner

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use:

KLH-100 Kronner Low Profile Scope Holder

For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.

HPL-2-30 High pressure flexible gas line set, double output

For abdominal, thoracic, arthroscopic endoscopic surgical procedures.

HPL-3-30 High pressure flexible gas line set, triple output

For nasal endoscopic surgical procedures.

KLH-200 Arm assembly

For abdominal, thoractic, arthroscopic and nasal" endoscopic surgical procedures.

*requires the Small Endoscope Accessory

C-100 Arm assembly

For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.

C-101 Control strap, replacement

For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.

SG-101 Scope grip strap, replacement

For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.

SMA-100 Small Endoscope Accessory

For nasal endoscopic surgical procedures

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Division of General Restorative Devices
510(k) Number K973543

Prescription Use
(Per 21CFR 801.109)

Over-The-Counter Use

8-1

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.