(43 days)
The RetCam Portable Ophthalmic Imaging System is indicated for general ophthalmic imaging including retinal, corneal and external imaging.
The RetCam Portable Imaging System is designed to quickly and easily capture wide field, digital images and videos of the eye. The optional hard side or soft side packaging allows for easy transport from one location to another within or outside the hospital or clinic. The reduced packaging dimensions enhance the ease of use in confined space situations.
This 510(k) summary for the RetCam Portable Ophthalmic Imaging System (K083771) indicates that its substantial equivalence to a predicate device (RetCam Shuttle Ophthalmic Imaging System, K081858) was established without specific performance criteria in terms of accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, the review focused on device description, intended use, and comparison to the predicate.
Therefore, the provided text does not contain the information needed to fill out the table and answer all the questions about acceptance criteria and a study proving device performance using quantitative metrics.
However, based on the information provided, here's what can be inferred or stated as "not applicable" given the context of a 510(k) for an ophthalmic imaging system that relies on substantial equivalence rather than novel performance claims:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative Metric) | Reported Device Performance (Quantitative Result) |
|---|---|
| Not specified in 510(k) summary | Not specified in 510(k) summary |
Explanation: The 510(k) summary does not define specific quantitative acceptance criteria for image quality, diagnostic accuracy, or other performance metrics. The basis for clearance is substantial equivalence to a predicate device (RetCam Shuttle Ophthalmic Imaging System, K081858) for "general ophthalmic imaging including retinal, corneal, and external imaging." This typically means the device performs similarly in its core function (capturing images) as the predicate, but numerical performance targets are not commonly included in these summaries.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. (The 510(k) summary focuses on regulatory approval based on equivalence rather than clinical trial data demonstrating specific performance against a test set).
3. 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.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified. (A dedicated test set with expert adjudication for performance metrics is not mentioned or implied by this 510(k) summary.)
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
- MRMC Study: No. This device is an imaging system, not an AI-powered diagnostic tool. The 510(k) summary does not mention any AI components or MRMC studies.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is an imaging device, not an algorithm, and the 510(k) summary does not describe any standalone algorithm performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable/Not specified. The 510(k) summary doesn't describe a study requiring ground truth for performance evaluation; rather, it establishes equivalence based on device specifications and intended use.
8. The sample size for the training set
- Sample Size: Not applicable/Not specified. The device is an ophthalmic imaging system, not a machine learning algorithm that requires a training set in this context.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not specified. (See point 8).
Conclusion based on the provided document:
The provided 510(k) summary for the RetCam Portable Ophthalmic Imaging System (K083771) details the device's regulatory classification, indications for use, and its substantial equivalence to a predicate device (RetCam Shuttle Ophthalmic Imaging System, K081858). It does not contain information regarding specific performance acceptance criteria (e.g., sensitivity, specificity, image quality metrics) or a study that quantitatively evaluates such performance with a test set, ground truth, or expert readers. The clearance is based on the device being a comparable imaging tool to an already legally marketed device.
§ 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.