(73 days)
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis.
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 POCone Infrared Spectrophotometer is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The POCone measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as A13CO2, and expressed as delta per mil (%) or Delta Over Baseline (DOB).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Executive Summary:
The POCone Infrared Spectrophotometer was compared to the predicate device, UBiT-IR300 Infrared Spectrophotometer, in a multi-center, prospective clinical study involving 220 subjects. The primary endpoint was percent agreement, and the device demonstrated very high agreement (99.55% overall) with the predicate device for detecting H. pylori infection using the 13C-urea breath test. A secondary endpoint showed a strong linear correlation between the two methods for Delta Over Baseline (DOB) values (r > 0.99). This clinical evidence, alongside non-clinical testing for reproducibility and carryover, supports the device's performance claims.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Clinical Performance | Overall Agreement with Predicate Device | High percentage agreement, demonstrating substantial equivalence in diagnostic classification (e.g., >95% or similar to predicate's known accuracy) | 99.55% (95% CI: 97.67, 99.98) |
| Positive Agreement with Predicate Device | High percentage agreement for positive cases | 100.00% (95% CI: 95.90, 100.00) | |
| Negative Agreement with Predicate Device | High percentage agreement for negative cases | 99.25% (95% CI: 96.27, 99.96) | |
| Correlation of DOB values with Predicate Device | Strong linear correlation (e.g., r > 0.95) | r > 0.99 (very highly correlated and linearly related) | |
| Non-clinical Performance | Reproducibility | Device performs according to specifications | Demonstrated performance according to specifications |
| Carryover | Negligible carryover | Demonstrated negligible carryover | |
| Inter-device Variability | Negligible inter-device variability | Demonstrated negligible inter-device variability | |
| Electrical Safety / EMC | Compliance with relevant standards (IEC 60601-1, IEC 60601-1-2) | Complies with IEC 60601-1 and IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 220 evaluable subjects.
- Data Provenance: The study was a multi-center, prospective study conducted by recruiting subjects from five Physician Office Laboratory (POL)/Point of Care (POC) settings. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the US or under US regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study compares the POCone Infrared Spectrophotometer to a predicate device (UBiT-IR300) for measuring 13CO2 enrichment in breath. The "ground truth" for H. pylori detection is implicitly established by the UBiT-IR300 itself, which is a legally marketed predicate device.
- Number of Experts: Not applicable in the traditional sense, as the ground truth for this comparative study is the result obtained from the predicate device (UBiT-IR300) when analyzing the same breath samples.
- Qualifications of Experts: Not specified or relevant, as no human experts were directly establishing a diagnostic ground truth by interpreting images or clinical signs for the purpose of this device comparison.
4. Adjudication Method for the Test Set
Not applicable. The study is a direct technical comparison between two devices analyzing the same breath samples. The comparison is objective (numerical Delta Over Baseline values and classification based on a 2.4 DOB cut-off). There is no "adjudication" in the sense of resolving discrepancies between human readers or between human readers and an AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance equivalence of a new spectrophotometer device to a predicate device, not on the effectiveness of human interpretation with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the study is essentially a standalone (algorithm only) performance comparison. Both the POCone and the UBiT-IR300 operate as automated analytical instruments. Their output (Delta Over Baseline values) is generated without human interpretation of raw data, and a pre-defined cut-off (2.4 DOB) is applied for classification. The human element is involved in collecting breath samples, but the measurement and classification are automated by the devices.
7. The Type of Ground Truth Used
The ground truth for this specific study is the results obtained from the legally marketed predicate device, the UBiT-IR300 Infrared Spectrophotometer. For the broader application of H. pylori detection, the 13C-urea breath test itself is an established method to detect H. pylori infection, often correlated with biopsy and culture (though not directly investigated in this specific submission).
8. The Sample Size for the Training Set
Not applicable. This device is an infrared spectrophotometer, which measures physical properties (13CO2/12CO2 ratios). It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The device's operational parameters and calibration would be set during manufacturing and validated through engineering tests, not a clinical training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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).