The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.

Device Description

The Olympus Neuroendoscope is a rigid endoscope indicated for intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal environments.

AI/ML Overview

The provided text is a 510(k) summary for the Olympus Neuroendoscopes. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the new device.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found within the provided document. This type of information is typically part of detailed validation studies that support the 510(k) submission, but is not usually included in the publicly available summary.

However, based on the information that is present, here's what can be extracted and inferred:

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

The document does not explicitly state "acceptance criteria" for performance. Instead, it provides a comparison table of key physical specifications between the predicate device and several subject devices, implying that equivalent physical characteristics are a basis for substantial equivalence.

Item	Predicate device, model A7594A	Subject device, S-1349/1	Subject device, S-1349/2	Subject device, S-1349/3	Subject device, S-1349/4
Telescope Diameter	Ø 4 mm	Ø 4 mm	Ø 2.7 mm	Ø 2.7 mm	Ø 2.7 mm
Telescope Total Length	218.5 mm	218.5 mm	225.3 mm	225.0 mm	233 mm
Telescope Working Length	158.1 mm	158.1 mm	158.1 mm	157.7 mm	156.7 mm
Lens Diameter	Ø 2.8 mm	Ø 2.8 mm	Ø 1.7 mm	Ø 1.7 mm	Ø 1.9 mm
Field of view	95.8°	95.8°	70.8°	68.4°	85°
Direction of view	0°	0°	0°	30°	70°
Best working distance	10 mm	10 mm	10 mm	10 mm	10 mm
Magnification	2.1	2.1	2.15	2.22	2.19

The implied "acceptance criterion" for these parameters is substantial equivalence to the predicate device, meaning the new devices' specifications are either identical or sufficiently similar not to raise new questions of safety or effectiveness. The table shows the performance (specifications) of the new devices in direct comparison to the predicate.

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

This information is not provided in the document. For medical devices like endoscopes, "test set" might refer to the number of devices tested for mechanical, optical, and biocompatibility properties. The document is a regulatory submission, not a scientific study report detailing clinical trial data.

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 in the document. It's unlikely that "experts" were used in this manner for the substantial equivalence demonstration of an endoscope's physical properties. If any clinical performance data were submitted (which is not detailed here), then expert assessment might be relevant, but it's not mentioned.

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

This information is not provided in the document. Adjudication methods are typically used in clinical studies where expert consensus is needed.

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

No, a MRMC comparative effectiveness study was not done, as this device (Olympus Neuroendoscope) is an optical instrument for direct viewing, not an AI-assisted diagnostic tool for "human readers." Therefore, effect size related to AI assistance is irrelevant and not applicable here.

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

No, a standalone algorithm performance study was not done. This device is an endoscope, which is a tool used by a human surgeon; it is inherently "human-in-the-loop" and does not operate as a standalone algorithm.

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

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for image classification or outcomes for predictive models) is not applicable in the context of this 510(k) submission for a rigid endoscope. The "truth" being established is that the device meets its stated physical specifications and is safe and effective when compared to an already legally marketed predicate device. This is typically verified through engineering testing and biocompatibility assessments, not through clinical "ground truth" data as understood for AI.

8. The sample size for the training set

This information is not provided and is not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

This information is not provided and is not applicable, as there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

OCT 0 8 2002

020507

OLYMPUS

WINTER & IB

Business address: Kuehnstr. 61 D-2204 Mailing address: Postfach 70 17 09 D-2201' Tel: +49-40-6 69 66-0 Telefax +49-40-6 68

Olympus Neuroendoscopes

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDS 1990 and 21 CFR Part 807.92

Submitter's Name, Address, Phone, Coutact Person and Summary Date A.

Olympus Winter & Ibe Manufacturer of subject device: Keuhnstr. 61 D-22045 Hamburg Germany 8010313 Registration number: Contact Person:

Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville NY 11747-3157

Telephone: (631) 844-5688

B. Device Name

Device Name: Olympus Neurocndoscopes

Common/Usual Name: Neurological endoscopes

Neurological endoscope Classification Name:

Classification: 21 CFR 882.1480 Class II

C. Predicate Devices:
Olympus Neuroendoscopes (K971340)

Device Description D.

The Olympus Neuroendoscope is a rigid endoscope indicated for intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal environments.

{1}------------------------------------------------

Intended Use of Device £.

The Olympus Neuroendoscopes are intendod for viewing the ventricles of the brain and for use in The Orympus Neurochaosopes are meeters and shunt placement and shunt placement and for ondoooopto absteted instruction of the rovascular compression syndromes.

Item	Predicatedevice, modelA7594A	Subjectdevice, S-1349/1	Subjectdevice, S-1349/2	Subjectdevice, S-1349/3	Subjectdevice, S-1349/4
Telescope Diameter	Ø 4 mm	Ø 4 mm	Ø 2.7 mm	Ø 2.7 mm	Ø 2.7 mm
Telescope TotalLength	218.5 mm	218.5 mm	225.3 mm	225.0 mm	233 mm
Telescope WorkingLength	158.1 mm	158.1 mm	158.1 mm	157.7 mm	156.7 mm
Lens Diameter	Ø 2.8 mm	Ø 2.8 mm	Ø 1.7 mm	Ø 1.7 mm	Ø 1.9 mm
Field of view	95.8°	95.8°	70.8°	68.4°	85°
Direction of view	0°	0°	0°	30°	70°
Best working distance	10 mm	10 mm	10 mm	10 mm	10 mm
Magnification	2.1	2.1	2.15	2.22	2.19

Comparison to Predicate Devices F.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Storms-Tyler Director Regulatory Affairs and . Quality Assurance Olympus America, Inc. 2 Corporate Center Drive Melville, New York 11747

Re: K020507

Trade/Device Name: Olympus Neuroendoscope Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: July 3, 2002 Received: July 10, 2002

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. Iisting 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 (PMA), 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.

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.

Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. The bottom half of the circle is blank. Inside the circle is a stylized design that resembles an abstract representation of a human form.

OCT 08 2002

OCT 0 8 2002

{3}------------------------------------------------

Page 2 - Ms. Storms-Tyler

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K020507

Device Name: Olympus Neuroendoscope

Indications for Use:

(Please do not write below this line. Continue on another page is needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE) X Prescription Use _ the-Counter Use (Per 21 CFR 801.109) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).