The PNM 60 is a diagnostic device indicated to provide digital photographs of the interior of the eye as well as the anterior segment and external part of the eye.

Device Description

The PNM 60 is a modification of the legally marketed Panoret 1000 A K001111 Digital Retinoscope. It is based on transcleral illumination. Its optics distinguishes the illumination path from the imaging path, thus, enables non mydriatic wide angle imaging. The Panoret viewing angle has been changed from (Panoret 1000A) 100 degrees to PNM 60 degrees

AI/ML Overview

This 510(k) summary (K040325) for the MEDIBELL PNM 60 device is a Special 510(k) for a modification of a legally marketed device (Panoret 1000A). As such, it primarily focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed information about a comprehensive clinical study to establish new acceptance criteria and prove performance in the same way a de novo device would.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not explicitly present in the provided document. The submission relies on the predicate device's established safety and effectiveness.

Here's an analysis based only on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance

Since this is a Special 510(k) for a modification, explicit acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity for a specific disease) are not defined. The acceptance is based on demonstrating that the modified device (PNM 60) remains substantially equivalent in safety and effectiveness to the predicate device (Panoret 1000A) despite the changes.

The key change mentioned is the viewing angle:

Panoret 1000A: 100 degrees
PNM 60: 60 degrees

The "study" to prove this device meets acceptance criteria is the Special 510(k) submission itself, which argues for substantial equivalence.

Acceptance Criteria (Inferred from 510(k))	Reported Device Performance (PNM 60)
Substantially equivalent in safety to predicate (Panoret 1000A)	"Panoret PNM device is designed to comply with the requirements of the IEC-60601-1 safety standard." Light controls adjusted for modification.
Substantially equivalent in effectiveness to predicate (Panoret 1000A)	Provides "digital photographs of the interior of the eye as well as the anterior segment and external part of the eye" (same intended use as predicate).
Change in viewing angle from 100 to 60 degrees does not negatively impact safety/effectiveness for intended use.	Viewing angle changed to 60 degrees. (Implicitly, this change is presented as not impacting safety or effectiveness for the stated intended use).
Compliance with IEC-60601-1 safety standard	Explicitly stated compliance with IEC-60601-1.
Not raise different questions of safety and effectiveness	The submission's purpose is to argue this.

Detailed Study Information (Based on provided text)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. As a Special 510(k) focusing on manufacturing and design changes, a traditional "test set" for clinical performance evaluation (like in an AI algorithm) is not described. The evaluation likely involved engineering verification/validation and functional testing with potentially a small number of human subjects or no human subjects at all, primarily to confirm the safe operation of the modified hardware.
- Data Provenance: Not specified. Given the nature of the submission (modification of an existing device), the testing would likely have been conducted by the manufacturer (MEDIBELL) in Israel. It would be considered prospective in the sense of testing the modified device, but not in the sense of a large-scale clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Reasoning: Ground truth is usually established for classifications or diagnoses made by a device. This submission is about a digital camera (retinoscope), which captures images, not interprets them to make a diagnosis. Therefore, the concept of "ground truth" for a diagnostic outcome, as typically applied to AI, isn't directly relevant in this context. The evaluation would focus on image quality, brightness control, and device functionality.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. Likely "none" as there's no mention of expert review of images for diagnostic purposes in a clinical study. Assessment would be based on technical specifications and functional testing.
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:
- MRMC Study: No. This device is an ophthalmic camera, a hardware device, not an AI algorithm.
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable. This is a hardware device, not an AI algorithm. Its performance is about capturing images, not interpreting them.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable in the sense of clinical diagnostic ground truth. For a device like this, "ground truth" would relate to objective measurements of image quality, resolution, illumination, safety parameters (e.g., light output), and functionality (e.g., "does it capture an image of the interior of the eye at 60 degrees?"). This would be established through engineering tests, optical measurements, and adherence to safety standards.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a hardware device. No "training set" in the context of machine learning is mentioned or implied.
How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable.

Summary

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MAR - 8 2004

510(k) Summary of Safety and Effectiveness (in accordinate to 21 CFR 307.87(h))

Device Name

Proprietary Device Name : PNM 60.

Establishment Name and Registration Number of Submitter

Name: MEDIBELL, MEDICAL VISION TECHNOI.OGHES LTD Registration: 3003809739 Corresponding Official: Dan Laor MATAM Haifa, 31905 Israel

Device Classification

Classification Code: Regulation Number: Panel Identification: Classification Class: 86 HKI 886.1120 Ophthalmic Class II Product

Reason for 510(k) Submission

Modification of a legally marketed device. Special 510(K)

Identification of Legally Marketed Equivalent Devices

K001111 Panoret 1000A

Device Description

Intended Use of Device

The PNM 60 is a diagnostic device indicated to provide digital photographs of the interior of the eye as well as the anterior segment and external part of the eye,

Safety & effectiveness information

Panoret PNM device is designed to comply with the requirements of the IEC-60601-1 safety standard.

Brightness control: The relative spectral radiant power distribution and the photometric luminance have been changed. The device built-in light controls and the device operation have been adjusted to compensate for the modification.

Substantial Equivalency

It is Medibell opinion that the PNM 60 is substantially equivalent in terms of safety and effectiveness to the legally marketed Panoret 1000A K001 111.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2004

Medibell Medical Vision Technologies Ltd. c/o Dan Laor, General Manager MATAM Haifa, 31905 Israel

Re: K040325

Trade/Device Name: PNM 60 Regulation Number: 21 CFR 886.1120 Regulation Name: O phthalmic camera Regulatory Class: Class II Product Code: HKI Dated: February 5, 2004 Received: February 17, 2004

Dear Mr. Laor:

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.

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.

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Page 2 - Dan Laor, General Manager

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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K040325

510(k) Number (if known):

DEVICE NAME:

INDICATION FOR USE: The PNM 60 is a diagnostic device indicated to provide digital photographs of the interior of the eye as well as the anterior segment and external part of the eye.

(Please do not write below this line - continue on another page if needed)

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

Denis L. McCarthy

Division of Ophthalmic Ear,
Nose and Throat Devises

6325

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-the-Counter Use_ OR

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.