(266 days)
The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco Demetra Skin Parameter Maps Tool provides maps that show the relative location of blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to complement dermoscopy.
The Barco Demetra Analytics Toolkit is a software application used to support analysis of dermoscopic images captured with the Barco Demetra BDEM-01 dermatoscope (K192829). The system is intended for use by medical practitioners. Scatter Contrast Maps provide additional information to dermoscopy by highlighting surface contours. The Skin Parameter Maps Tool provides images generated from multispectral image sets and aids the user in visualizing blood and pigment patterns in the skin. The output of the Skin Parameter Maps is shown to the user as grayscale two-dimensional maps. The maps are intended only to complement dermoscopy.
The provided text describes several clinical validation activities for the Demetra Analytics Toolkit, but it does not explicitly state specific acceptance criteria in a quantitative manner (e.g., minimum sensitivity, specificity, or agreement score). Instead, it describes general performance testing and multiple clinical studies aiming to support the device's safety and effectiveness and its substantial equivalence to a predicate device.
Given this limitation, I will infer the "acceptance criteria" from the descriptions of the studies and their reported "PASS" results for software verification, usability engineering, and design validation. The implicit acceptance criteria appear to be that the device "performs as well as the legally marketed predicate device" and that the evaluations did not "reveal new issues of safety and performance."
Here's an attempt to structure the information based on your request, acknowledging the gaps in explicit quantitative acceptance criteria:
Acceptance Criteria and Device Performance
The provided document does not explicitly define quantitative acceptance criteria for the Demetra Analytics Toolkit's clinical performance (e.g., specific accuracy, sensitivity, or agreement thresholds). Instead, the studies aim to demonstrate that the device is "as safe, as effective, and performs as well as the legally marketed predicate device." The "Result" column in the table below reflects the general "PASS" status for foundational tests and the overall conclusion of substantial equivalence.
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Category/Test | Implicit Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Software Verification Testing | Software functions as intended and meets specifications. | PASS |
| Usability Engineering Testing | Device is safe and effective for its intended users and use environments. | PASS |
| Design Validation | Device functions as specified, including integration with the BDEM-01 device. | PASS (Implied by overall conclusion and no issues reported) |
| Clinical Validation Activities | Device performance is comparable to the predicate device and supports stated Indications for Use without new safety/effectiveness issues. | Supported by multiple retrospective and prospective studies, leading to a conclusion of substantial equivalence. |
Study That Proves the Device Meets the Acceptance Criteria:
The document describes five distinct clinical validation activities. It's important to note that these studies collectively support the device's substantial equivalence to the predicate device, rather than each proving specific quantitative "acceptance criteria" for clinical performance.
2. Sample Sizes and Data Provenance:
- "Clinical validation of Demetra Skin Parameter Maps" (Retrospective Reader Study):
- Test Set Sample Size: 28 cases
- Data Provenance: Retrospective, mixed dermatology conditions, focus on skin lesions suspicious for skin cancer, no country explicitly stated but experts were from USA.
- "SIAScans vs. Barco Analytics Toolkit" (Retrospective Study):
- Test Set Sample Size: "representative set of specific types of cases" (exact number not specified)
- Data Provenance: Retrospective, from OHSU Dermatology Clinic, Portland (USA).
- "Correlation of structures visualized in the Skin Parameter Maps with pathology findings" (Prospective Clinical Study):
- Test Set Sample Size: 15 cases
- Data Provenance: Prospective, from Washington DC (USA) and Maryland (USA).
- "Validation of skin structures imaged in the Skin Parameter Maps" (Clinical Study):
- Test Set Sample Size: 15 cases
- Data Provenance: From University Hospital Leuven in Belgium.
- Clinical Study at Charité Universitätsmedizin Berlin & Oregon, USA (Retrospective Reader Study):
- Test Set Sample Size: 28 representative cases
- Data Provenance: Retrospective, from existing database, conducted in Germany and Oregon, USA.
3. Number of Experts and Qualifications:
- "Clinical validation of Demetra Skin Parameter Maps":
- Number of Experts: 4
- Qualifications: Board certified dermatologists from different sites in the USA.
- "SIAScans vs. Barco Analytics Toolkit":
- Number of Experts: 1
- Qualifications: Board certified dermatologist from OHSU Dermatology Clinic, Portland.
- "Correlation of structures visualized in the Skin Parameter Maps with pathology findings":
- Number of Experts: 2
- Qualifications: Board certified dermatologist from Washington DC; and a dermatopathologist from Maryland.
- "Validation of skin structures imaged in the Skin Parameter Maps":
- Number of Experts: 1
- Qualifications: Dermatologist from University Hospital Leuven.
- Clinical Study at Charité Universitätsmedizin Berlin & Oregon, USA:
- Number of Experts: 4 observers (qualifications not explicitly stated beyond "observers," but context implies medical professionals, likely dermatologists).
4. Adjudication Method for the Test Set:
The document mentions "statistical analysis was performed on the collected ratings" for several studies, but it does not specify an adjudication method (e.g., 2+1, 3+1) for cases where expert opinions might differ in reader studies. For the studies comparing maps to pathology or physical structures, it implies direct comparison or subjective rating/qualitative analysis rather than expert consensus on a ground truth prior to analysis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? Yes, several of the described studies, particularly the "retrospective reader study" involving multiple board-certified dermatologists, appear to be MRMC in nature, as they involve multiple readers evaluating multiple cases. However, the studies are framed as "validation activities" and comparisons for substantial equivalence, rather than a direct MRMC comparative effectiveness study aiming to quantify human reader improvement with AI vs. without AI assistance.
- Effect Size of Human Readers Improving with AI vs. Without AI Assistance: The document does not report any effect size for how much human readers improve with AI assistance vs. without AI assistance. The described studies focus on validating the skin parameter maps themselves and comparing them to existing methods/predicate devices. The device is intended "only to complement dermoscopy," suggesting its role as an adjunct.
6. Standalone (Algorithm Only) Performance:
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for the Demetra Analytics Toolkit. The device provides "maps that show the relative location of blood and pigment" which are "intended only to complement dermoscopy." Its function is described as aiding the user in visualizing patterns, indicating it's an assistive tool for a human reader rather than a diagnostic algorithm operating in isolation.
7. Type of Ground Truth Used:
The ground truth for the test sets varied across the studies:
- Expert Consensus/Subjective Rating: For several reader studies ("Clinical validation of Demetra Skin Parameter Maps," "Validation of skin structures imaged in the Skin Parameter Maps," Clinical Study at Charité/Oregon), the "ground truth" for evaluation appears to be the subjective ratings and qualitative feedback directly from the participating dermatologists/observers on the utility and consistency of the maps.
- Pathology Findings: For the "Correlation of structures visualized in the Skin Parameter Maps with pathology findings" study, the ground truth was pathology H&E images.
- Predicate Device Performance: For "SIAScans vs. Barco Analytics Toolkit," the performance of the predicate device (Siascope) served as a comparative reference.
- Physical Structures/Clinical Use: For "Validation of skin structures imaged in the Skin Parameter Maps," the ground truth was the expected clinical utility and visualization of skin structures by a dermatologist. For "Clinical validation of Demetra Skin Parameter Maps," the cases represented "various dermatology conditions for which a dermatologist can use a dermatoscope."
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for the training set of the Demetra Analytics Toolkit's algorithms.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information on how the ground truth for the training set was established. Given the focus on clinical validation for substantial equivalence and the absence of standalone AI performance claims, details about the model's training might not have been explicitly required or provided in this summary.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.