(72 days)
The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse
- · Corneal shape
- · Lens shape
- · Pachymetry (thickness of the cornea)
- · Pupil size
- · Lens thickness
- · Condition of the lens
- o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
- State of the lens (opaque crystalline lens) o
- · Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings)
- · Anterior chamber (size, volume and angle)
- · Scheimpflug Image
- · Position of the cornea relative to iris and lens
The CM 3910 Double-Scheimpflug Camera is a non-invasive, diagnostic system designed for the analysis of the anterior eye segment by means of Scheimpflug and Placido images. The Scheimpflug images are based on the Scheimpflug Principle for Slit Image photography. The system is table mounted and AC powered. The device consists of a measurement unit and a control unit with a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for taking images. The measuring unit takes pictures by a rotating scan of the anterior eye segment. It also includes a top view for eye tracking means and Placido imaging in the near infrared. From the acquired pictures, the control unit calculates a 3D-model and the topography of the eye.
The provided text is a 510(k) summary for the CM 3910 Rotating Double Scheimpflug Camera. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. While it describes the intended use, device description, and comparison to predicate devices, it does not provide specific acceptance criteria or an analytical study proving the device meets those criteria in the way you've requested for performance metrics like sensitivity, specificity, etc.
The summary states: "The CM 3910 is proven effective for its intended uses through internal performance tests." However, it does not elaborate on these internal performance tests, their methodologies, acceptance criteria, or the results.
Therefore, many of your requested points cannot be answered from the provided text. I will address the points that can be inferred or explicitly stated.
Acceptance Criteria and Study for CM 3910 Rotating Double Scheimpflug Camera:
Based on the provided 510(k) summary, the primary "acceptance criterion" for this device, as presented to the FDA, is its substantial equivalence to existing legally marketed predicate devices (Pentacam Scheimpflug Camera and Orbscan II™ Keratometer). The study that "proves the device meets the acceptance criteria" is essentially the product comparison demonstrating this substantial equivalence on various characteristics.
The summary highlights the following as rationale for substantial equivalence, implying these are the key "acceptance criteria" for demonstrating equivalence:
- Same intended use: Taking photos of the anterior segment of the eye for evaluation and analysis.
- Same measuring principles: Slit Scan and Placido Disc.
- Same photographic medium: CCD Camera.
- Comparable light sources: Wavelength and intensity.
- Same features: Head stabilizing device, fixation target, joystick.
- Classification: Non-invasive as defined in 21 CFR §812.3(k).
Here's a breakdown of your requested information, with disclaimers for what is not present in the document:
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Table of acceptance criteria and the reported device performance:
- Note: The document does not provide quantitative acceptance criteria (e.g., target accuracy, precision, sensitivity, specificity) for specific clinical measurements (e.g., corneal shape, pachymetry) of the CM 3910, nor does it provide detailed quantitative performance results from a clinical study for these parameters. The "performance" assessment here is implied through comparison to predicate devices.
Acceptance Criterion (Implied for Substantial Equivalence to Predicate) Reported Device "Performance" (Comparison to Predicate) Intended Use CM 3910: Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye, to evaluate and analyze various parameters (Corneal shape, Lens shape, Pachymetry, Pupil size, Lens thickness, Condition of the lens (cataracts, opaque lens), Condition and position of implants, Anterior chamber (size, volume, angle), Scheimpflug Image, Position of the cornea relative to iris and lens).
Predicate (Pentacam): Same.
Predicate (Orbscan II™): Scan, map and display the geometry of the anterior segment of the eye (broader, but overlaps). Conclusion: Same intended use. |
| Measuring Principle | CM 3910: Rotational scan of Double-Scheimpflug slit images merged with Placido Disc images.
Predicate (Pentacam): Rotational scan of Scheimpflug slit images.
Predicate (Orbscan II™): Parallel scanned slit images and Placido Disc images. Conclusion: Uses same core principles (Slit Scan and Placido Disc). |
| Photographic Medium | CM 3910: CCD Camera.
Predicate (Pentacam): CCD Camera.
Predicate (Orbscan II™): CCD Camera. Conclusion: Same photographic medium. |
| Light Sources | CM 3910: Blue LED Light (UV-free) 470 nm, max. 15 mWsec.
Predicate (Pentacam): Blue LED Light (UV-free) 475nm, max. 2.5 Wsec.
Predicate (Orbscan II™): Not specified for flash. Infrared LED 810nm for observation (CM 3910) vs 800nm (Pentacam). Conclusion: Comparable wavelength and intensity (CM 3910 and Pentacam). |
| Core Features | CM 3910: Head stabilizing device, fixation target, joystick for measurement head adjustment.
Predicates: Implied to have similar features or the absence of new/different features in CM 3910 does not raise safety/effectiveness concerns. Conclusion: Uses the same features. |
| Classification | CM 3910: Class II, MXK.
This classification is not directly stated for the predicates in this document, but implied to be equivalent. Conclusion: Non-invasive diagnostic system. |
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Sample size used for the test set and the data provenance:
- Not provided. The document states "The CM 3910 is proven effective for its intended uses through internal performance tests," but it does not describe any specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "test" presented for FDA submission is the comparison to predicate devices, which relies on the established performance of those devices rather than new clinical data for the CM 3910.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since no specific clinical test set and ground truth establishment methodology are described for the CM 3910's "internal performance tests" in this summary, information about experts and their qualifications is not available.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication method is mentioned as a specific clinical test set is not described.
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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:
- Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool for human readers in the traditional MRMC sense. It provides images and calculated parameters. The document does not describe any studies comparing human reader performance with or without the device, or with differing versions of the device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to an extent. The "internal performance tests" mentioned are likely standalone tests evaluating the device's ability to acquire and process images and calculate parameters. The device itself is an "algorithm only" type in that it performs calculations based on acquired images to provide data like corneal shape, pachymetry, etc. The document does not provide details of these tests or their results. The "Product Comparison" table implicitly serves as a standalone comparison against predicate device specifications.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. For the device's "internal performance tests," the type of ground truth used is not specified. For the substantial equivalence argument, the "ground truth" is essentially the established safety and effectiveness of the legally marketed predicate devices.
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The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/ML device relying on a "training set" in the common sense, no such information is provided. Its calculations are based on established optical and geometric principles.
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How the ground truth for the training set was established:
- Not applicable / Not provided. See point 8.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.