(27 days)
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.
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
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)
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable.
§ 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.