(129 days)
The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
The CBI 7520 microplate reader employs an automatic transport mechanism to bring the individual microplate wells into position for reading. The device employs Tungsten halogen lamp as the light source. The device uses silicon-photodiodes to measure the light absorbance.
This document describes a 510(k) premarket notification for the CBI 7520 Microplate Reader. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria in the manner typically seen for novel AI/ML medical devices.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text. The device described, a microplate photometer, does not involve AI, and thus concepts like "AI assistance," "ground truth," or "expert consensus" for image analysis are not relevant here.
Here's an analysis based on the provided text, addressing the points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or a detailed "reported device performance" in the way one would for a new diagnostic assay or AI algorithm. Instead, the basis of equivalence is qualitative similarity in intended use, principles of operation, and technical characteristics.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Basis for Equivalence) |
|---|---|
| Same intended use as predicate devices | The CBI 7520 has the same intended use (general purpose microplate photometer for clinical use). |
| Same indications for use as predicate devices | The CBI 7520 has the same indications for use. |
| Same principles of operation as predicate devices | All devices (CBI 7520 and predicates) share the same principle of operation: light source illuminates wells, silicon-photodiodes measure light absorbed, data reduction software yields absorbance value. |
| Similar technical characteristics to predicate devices | All devices employ automatic transport, Tungsten halogen lamp as light source, and silicon-photodiodes for absorbance measurement. |
| No substantial difference in performance compared to predicate devices | "There is no substantial difference between the CBI 7520 and its predicate devices in performance or technical characteristics." (This is a statement of conclusion, not a presentation of performance data against specific criteria). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a performance study with a test set of samples/data. It relies on demonstrating similarity to already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication process is described.
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
Not applicable. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as applied to diagnostic algorithms is not relevant for this device's submission.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(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 § 862.9.