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The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy.

For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas.

For administration by health care professionals. To be administered under a physician's supervision.

The scientific basis underlying the BreathTek™ UBT and the BreathTek™ -UBiT® UBT kit is identical. Both kits contain a pouch of Pranactin-Citric drug product, a reconstitution cup, sample collection containers, sample identification labels and a package insert. The parts lists of the two kits differ for types of sample collection containers, the configuration of the barcode labels and the quantity of straws provided. The UBiT version of the kit directly collects breath samples into two 300cc breath bags each fitted with a mouthpiece containing a check valve and the original kit collects breath samples via a straw into glass test tubes. The glass test tubes must be quickly sealed with screw-on caps to contain the breath; the check valve incorporated in the breath bags eliminates this concern. The original kit contains a back-up set of sample collection tubes to compensate for the fragility of the tubes' glass structure. Use of barcode labels will be mandatory for the original kit and optional for the UBiT version.

The two kits will coexist on the market and share the same package insert. The package insert will be modified to include the UBiT version's component list and step-by-step procedure for collecting samples. The package insert will instruct the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer.

The provided text describes a 510(k) premarket notification for a medical device called "BreathTek™ - UBiT® UBT for H. pylori." This submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way a clinical trial typically would for a new device's efficacy.

However, based on the information provided, we can infer some aspects and address the questions to the best of our ability within the context of a 510(k) submission for equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific sensitivity, specificity, or other diagnostic metrics for the BreathTek™ - UBiT® UBT for H. pylori. Instead, the submission is focused on demonstrating substantial equivalence to an already marketed device (BreathTek™ UBT for H. pylori).

The core "acceptance criteria" in this context is likely that the modified device (with breath bags) performs equivalently to the predicate device (with glass tubes) such that the diagnostic results regarding H. pylori detection are comparable.

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: Not explicitly stated. The document mentions "Human breath samples" and "simulated breath samples," but does not quantify the number of each.
• Data Provenance: Not explicitly stated. The context of a US-based company submitting to the FDA suggests the testing would adhere to US regulatory standards, but the specific country of origin for the samples is not provided. The testing appears to be prospective as freshly collected "human breath samples" were used.

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. The document describes a technical equivalence study focusing on sample collection methods and stability, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The predicate device's diagnostic performance, based on its existing FDA approval (NDA # 20-586/S-004), is referenced.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was not a diagnostic accuracy study involving adjudication of clinical cases.

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 device is a breath test for H. pylori detection, not an AI-assisted diagnostic imaging or interpretation system. Therefore, an MRMC study with AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a diagnostic test kit that still requires human interaction for sample collection and analysis by a spectrometer, not a standalone algorithmic diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the stability study, the "ground truth" would be the known initial composition of the breath samples (both human and simulated) for the stability measurements. For the diagnostic accuracy of H. pylori, the ground truth would be established through methods typically used for validating such tests, likely via biopsy and histological examination or other established H. pylori detection methods, but this is related to the predicate device's original approval, not explicitly detailed here for the equivalence study.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set in the conventional sense. The "training" here refers to the development and validation of the collection methods and stability.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML device. For the H. pylori diagnostic capability of the overall system (predicate and proposed), the ground truth for diagnostic accuracy would have been established during the original NDA approval for the Pranactin-Citric drug product and the associated breath test.

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The MERETEK UBT® Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy. For these purposes, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.

For administration by health care professionals. To be administered under a physician's supervision.

The device is a combination kit diagnostic drug/device composed of the following principle components: Test Meal (of approximately 220 calories), Pranactin Diagnostic Drug Dosage, Sterile Water, Breath Bag, Evacuated Breath Specimen Collection Tubes. In the MERETEK UBT® Breath Test for H. pylori, 125 mg of reconstituted 13C-urea is ingested by the patient. In the presence of urease associated with gastric H. pylori, 13Curea is decomposed to 13CO2 and NH4+. The 13CO2 is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of 13CO2 to 12CO2 in a TEST breath sample compared to a BASELINE sample taken before the Pranactin® solution was consumed. Analysis of the breath samples is performed by Gas Isotope Ratio Mass Spectrometry ("GIRMS").

Here's a breakdown of the acceptance criteria and study details for the MERETEK UBT® Breath Test for H.pylori, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "Sensitivity must be >= X%"). Instead, it presents the device's performance characteristics as "results" in comparison with established diagnostic methods. The implicit acceptance is based on the reported sensitivities and specificities, which are deemed sufficient by the FDA for the device's intended use.

Here's a table summarizing the reported device performance compared to various ground truth methods:

Study Details

1. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Initial Diagnosis): The tables show different totals depending on the comparison method:
  • Comparison with CLOtest®: 445 patients
  • Comparison with Histology: 444 patients
  • Comparison with Combined Endoscopic Methods: 444 patients
• Sample Size (Post-Treatment Monitoring):
  • 1 Month EOT: 295 patients
  • 3 Months EOT: 222 patients
  • 6 Months EOT: 178 patients
  • 1-6 Months Combined: 495 patients (sum of positive and negative cases; the total number of unique patients is not explicitly stated as the sum of EOT, but it's derived from the combined table entries.)
• Data Provenance: The studies included "499 adult patients with duodenal ulcer disease at 75 clinical sites in the United States." The data is prospective as patients were followed through various post-treatment intervals. It is described as "two (2) independent double blind clinical field trials."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the specific "number of experts" or their detailed "qualifications" (e.g., "radiologist with 10 years of experience") for establishing the ground truth. However, it indicates that the ground truth methods used were:

• CLOtest®: A rapid urease test, typically read by laboratory personnel or clinicians.
• Histopathology: Involves microscopic examination of tissue samples, performed by pathologists.
• Microbiological culture: Growing bacteria from samples, performed by microbiologists.

These methods inherently require expertise in their respective fields (pathology, microbiology, and clinical interpretation of rapid tests).

3. Adjudication Method for the Test Set

The document describes the ground truth for initial diagnosis as being established by comparing the MERETEK UBT® Breath Test results with:

• CLOtest®
• Histology
• Combined endoscopic method results (CLOtest®, histology, and culture) per DAIDP guidelines.

For post-treatment monitoring, the ground truth was established by comparing the MERETEK UBT® Breath Test results with:

• Combined endoscopic methods (histology and culture) per DAIDP guidelines.

The specific "adjudication method" beyond using these combined references (e.g., a "2+1" rule for discordant results between the ground truth components) is not explicitly stated. It implies that the combined methods served as the reference standard.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study's focus was on the stand-alone performance of the MERETEK UBT® Breath Test against established diagnostic methods, not on how human readers improve with or without AI assistance. The device is a diagnostic test kit, not a software AI assistant for human interpretation.

5. If a Standalone Study Was Done

Yes, a standalone study was done. The entire clinical testing section describes the performance of the MERETEK UBT® Breath Test itself (the "algorithm only") in detecting H. pylori by measuring 13CO2/12CO2 ratios. The results (sensitivity, specificity) presented in the tables are precisely the standalone performance characteristics of the diagnostic test.

6. The Type of Ground Truth Used

The ground truth used was a combination of established clinical and laboratory diagnostic methods:

• For Initial Diagnosis: CLOtest®, Histopathology, and Microbiological Culture. The "combined endoscopic methods" standard for initial diagnosis included CLOtest®, histology, and culture.
• For Post-Treatment Monitoring: Histopathology and Microbiological Culture. The "combined endoscopic methods" standard for post-treatment monitoring included histology and culture.

These methods represent a form of expert consensus if multiple methods were combined to form a reference standard, or a pathology-like reference (histology and culture are pathology methods). It is not directly called "outcomes data," though the goal is to ultimately inform patient outcomes.

7. The Sample Size for the Training Set

The document does not specify a training set sample size. This implies that the device in question (MERETEK UBT® Breath Test) is a diagnostic kit with a fixed methodology (measuring 13CO2/12CO2 ratio) and does not involve AI or machine learning models that typically require a separate training set. The study described is for validation and performance assessment, not for training a model.

8. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" for an AI/ML model, the establishment of ground truth for a training set is not applicable to this document. The ground truth as described for the test set was established by concurrent clinical and laboratory diagnostic methods (CLOtest, histology, culture).

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The provided text is a 510(k) clearance letter from the FDA for a device called MERETEK UBT™. While it confirms the device's substantial equivalence and outlines regulatory requirements, it does not contain any information regarding the acceptance criteria for a study, nor does it present data from a study that proves the device meets those criteria.

The letter explicitly states: "Our substantially equivalent determination does not apply to the drug component (NDA 20-586) of your product." It then directs the manufacturer to contact the Center for Drug Evaluation and Research for information on applicable Agency requirements for marketing the drug component. This indicates that the clinical effectiveness and associated studies for the drug component, which is likely central to the device's function, would be handled under a separate NDA process, not detailed here.

Therefore, I cannot provide the requested information from the given text.

The document is solely a regulatory clearance letter and does not include scientific study details such as:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
6. Standalone performance study details: Not present.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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