(43 days)
The MLX measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results.
The MLX Microtiter® Plate Luminometer ("MLX") measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results. The Revelation software incorporated in the MLX was developed and manufactured in accordance with comprehensive software development, validation and verification procedures.
The provided document is a "Summary of Safety and Effectiveness" for the Dynatech Laboratories MLX Microtiter Plate Luminometer, a device cleared in 1996. This document is not a study that proves the device meets acceptance criteria in the way a modern AI/ML device study would. It's a statement for a 510(k) submission, confirming substantial equivalence to previously cleared devices.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to AI/ML, ground truth, and human reader performance) are not applicable or available in this type of document for this device.
Below, I will address the requested information to the extent possible given the content of the document, indicating when information is not available or not relevant to this type of device and submission.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of quantitative acceptance criteria or detailed performance metrics. It states:
- "Performance testing demonstrates the proper operation of the MLX in accordance with device specifications."
Without access to the actual "device specifications," it's impossible to create such a table. The document primarily focuses on demonstrating substantial equivalence to predicate devices (Dynatech ML3000 and ML2250 microplate luminometers) rather than presenting a detailed performance study with specific criteria and results for this particular submission.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. The document mentions "Performance testing" but does not detail the nature of these tests, the samples used, or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. This device is a luminometer, a laboratory instrument for measuring light. Its "performance" would be related to its accuracy, precision, dynamic range, and other technical specifications, not human interpretation of medical images or data requiring expert ground truth in the way an AI/ML device would.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. Given it's a laboratory instrument, performance would likely be evaluated against calibrated standards or known light sources, rather than requiring expert adjudication.
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 is not an AI/ML device, nor does it involve human readers interpreting data that would be enhanced by AI. It's a standalone laboratory instrument.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, implicitly. The device itself (the MLX luminometer) performs its function standalone by measuring light and processing data according to "defined test protocols." The "Revelation software" is an integral part of the device's function, but it's not described as an AI/ML algorithm separate from the device's core operation. The performance described is that of the device (luminometer and its software).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated, but for a luminometer, "ground truth" would typically involve:
- Calibrated light sources: Devices emitting a known photon count or intensity to test accuracy.
- Reference materials/standards: Samples with known bioluminescent or chemiluminescent properties.
- Internal calibration mechanisms: The device itself might have self-calibration routines.
The document only broadly states "Performance testing demonstrates the proper operation of the MLX in accordance with device specifications."
8. The sample size for the training set
- Sample size for training set: Not applicable in the context of an AI/ML training set. The "Revelation software" was developed using "comprehensive software development, validation and verification procedures." This refers to traditional software engineering practices, not AI/ML model training.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable. This refers to traditional software development and verification processes, not establishing ground truth for AI/ML training data. The ground truth for software testing would be adherence to functional requirements and absence of bugs, verified through testing against specifications.
Summary regarding the nature of the document:
This document is a regulatory submission demonstrating substantial equivalence for a medical device cleared in 1996, well before the widespread use of sophisticated AI/ML in medical devices. It confirms the mechanical and software components meet safety and effectiveness standards of the time by being similar to existing cleared devices. It does not contain the detailed study information typically associated with performance claims for modern AI/ML medical devices.
§ 866.2320 Differential culture medium.
(a)
Identification. A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purposes to cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.