(176 days)
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.
The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
The POC-AS10 Auto sampler is an optional accessory to the POCone Infrared Spectrophotometer. The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. By connecting the POC-AS10 Auto sampler to the POCone Infrared Spectrophotometer, up to ten pairs of breath collection bags (20 bags total) can be set up at one time.
The provided text describes a 510(k) premarket notification for the POC-AS10 Auto sampler, an accessory to the POCone Infrared Spectrophotometer. It focuses on device description, intended use, and substantial equivalence to a predicate device. However, it does not contain detailed information regarding acceptance criteria or a comprehensive study report with specific performance metrics for the device itself.
The "Performance Testing" section states: "The nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples. The testing demonstrated that the POC-AS10 Auto sampler accessory to the POCone Infrared Spectrophotometer successfully fulfilled prospectively defined verification and validation activities."
This statement confirms that testing was done and deemed successful against "prospectively defined verification and validation activities," but it does not explicitly list those acceptance criteria or the quantitative results of the studies. Therefore, I cannot populate the table or provide detailed answers to many of your questions based solely on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "prospectively defined verification and validation activities." | "successfully fulfilled prospectively defined verification and validation activities." (Specific quantitative results for reproducibility and carry-over are not provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document only mentions "reproducibility and carry-over studies using standard gas samples."
- Data Provenance: Not specified.
- Retrospective/Prospective: The verification and validation activities were "prospectively defined," implying the studies themselves were likely prospective in nature, but this is not explicitly stated for the data collection.
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/Not specified. The testing involved "standard gas samples," implying a technical or engineering validation rather than clinical ground truth established by medical experts for patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation of data, which is not the primary focus of the performance testing described for this auto sampler accessory.
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
- No, an MRMC comparative effectiveness study was not done. This device is an auto sampler accessory for an infrared spectrophotometer, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The "nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples" which can be considered a form of standalone performance testing for the accessory's mechanical and analytical function. However, it's not an "algorithm-only" test in the AI sense, but rather a system performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the reproducibility and carry-over studies, the "ground truth" would be the known concentration/composition of the "standard gas samples" used. This is a technical standard, not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Not applicable/Not specified. This document describes an accessory to a spectrophotometer, not a system that is "trained" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML system requiring a training set with established ground truth.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).