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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

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.

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The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.

The RAPIRUN H. pylori Antibody Detection Kit is an immunochromatographic method for the qualitative detection of anti-H. pylori antibodies in urine using a nitrocellulose membrane immobilized with proteins extracted from H. pylori as an antigen. The test device includes a sample window in which the test specimen is placed in a dropwise manner and an evaluation window in which a test line and a control line are visible. Colloidal gold-conjugated anti-human IgG (Fc) polyclonal antibody (goat) is present between the sample window and the evaluation window. The test line and the control line in the evaluation window are immobilized with H. pylori-extracted protein and with anti-human IgG polyclonal antibodies (goat), respectively.

When a urine specimen diluted with the sample diluent is added dropwise to the sample window, the IgG in the diluted sample reacts with the conjugated antibodies. Immunocomplexes are formed and flow into the nitrocellulose membrane. If anti-H. pylori IgG antibody complexes are present in these immunocomplexes, they react with the H. pylori antigen immobilizing on the test line and are captured producing a red band. On the other hand, immunocomplexes without anti-H. pylori IgG antibodies pass the test line and are captured by the anti-human IgG polyclonal antibodies (goat) immobilizing on the control line producing a red band. A test specimen is judged to be positive for anti-H. pylori antibodies if red colored bands appear in both the test zone and the control zone, or is judged to be negative for anti-H. pylori antibodies if a red colored band only appears in the control zone.

Here's a breakdown of the acceptance criteria and study details for the RAPIRUN H. pylori Antibody Detection Kit, based on the provided text:

Acceptance Criteria and Device Performance

• Note: The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that were required for clearance. Instead, it presents the results of the clinical study, which are then used to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria would be for the device's performance to be comparable to, or "substantially equivalent" to, the predicate devices.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: 188 evaluable subjects.
* Data Provenance: Prospective, multi-center study conducted at four Physician Office Laboratory (POL)/Point-of-Care (POC) settings. The country of origin is not explicitly stated, but the sponsor is Japanese and the contact information includes a US contact, suggesting the study was likely conducted in the US (given the FDA submission context).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* The study did not use human experts to establish "ground truth" for the test set in the traditional sense of diagnostic interpretation. Instead, it used predicate medical devices (HM-CAP™ H. pylori Enzyme Immunoassay Test and UBiT-IR300 Infrared Spectrophotometer) as the reference standards for comparison. Therefore, no information is provided about the number or qualifications of experts for ground truth establishment.

3. Adjudication Method for the Test Set:
* Not applicable. The "ground truth" was established by the results of predicate devices, not through expert consensus requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
* No, an MRMC comparative effectiveness study was not done. This was a direct comparison of the new device to existing predicate devices, not a study evaluating human reader performance with and without AI assistance.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
* Yes, this was a standalone performance study. The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay with visual interpretation of test and control lines. Its performance was evaluated purely based on its own output compared to the predicate devices, without human-in-the-loop assistance in the sense of an algorithm supporting a human reader.

6. The Type of Ground Truth Used:
* The "ground truth" for evaluating the RAPIRUN Kit was established by predicate medical devices:
* HM-CAP™ H. pylori Enzyme Immunoassay Test (serum)
* UBiT-IR300 Infrared Spectrophotometer method (breath)
* These predicate devices themselves are considered established methods for diagnosing H. pylori infection.

7. Sample Size for the Training Set:
* The document does not mention a "training set" or "training data" for the device itself. Immunochromatographic assays like the RAPIRUN Kit are typically developed and optimized through laboratory studies and then directly validated in clinical performance studies. They are not machine learning algorithms that require a distinct training phase with annotated data in the same way.

8. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no mention of a distinct "training set" or "ground truth for the training set" in the context of this device's development as described.

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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

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.

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The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags.

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.

The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 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 △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB).

The System consists of the following components:

• UBiT-IR300 Infrared Spectrophotometer -
• UBiT-AS10 Autosampler -
• Otsuka Breath Collection Bags -

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The device was compared against the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method.

Here's the breakdown of the acceptance criteria and study details:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. However, for a device seeking 510(k) clearance by demonstrating substantial equivalence, the expectation is that its performance is comparable to or non-inferior to the predicate device. The presented results clearly indicate a very high level of agreement and correlation, suggesting these metrics met the implicit requirements for substantial equivalence.

Study Details

1. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: 320 evaluable subjects.
     • 257 subjects from combined Physician Office Laboratory (POL) sites.
     • 63 subjects from one clinical laboratory site.
   • Data Provenance: The study was a multi-center, prospective study. The country of origin is not explicitly stated, but given the sponsor (Otsuka Pharmaceutical Co., Ltd., Japan) and the contact person's US number, it's likely a US-based or international study with US participant sites. The data is prospective as subjects were recruited and underwent the urea breath test for the study.

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

   • The ground truth in this study was established using the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. The study design directly compares the UBiT-IR300's results to the GIRMS method.
   • Therefore, the "experts" in this context are the established and recognized methodology of GIRMS for 13CO2 enrichment measurement. There's no mention of a separate panel of human experts in the traditional sense (e.g., radiologists) establishing ground truth, as it's a direct analytical comparison.

3. Adjudication Method for the Test Set:

   • Not applicable in the conventional sense. The "adjudication" is inherent in the comparison of the UBiT-IR300 results against the GIRMS method, which serves as the reference standard. Agreement and correlation were calculated based on this direct comparison.

4. 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, this was not an MRMC study. This study evaluated the performance of an analytical device (UBiT-IR300) directly against a reference analytical method (GIRMS) for measuring 13CO2 enrichment, not human reader performance.

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

   • Yes, this study represents a standalone performance evaluation of the UBiT-IR300 Infrared Spectrometry System. It measures the device's ability to accurately measure 13CO2 enrichment independently, with its results then compared to the established GIRMS method.

6. The type of ground truth used:

   • The ground truth was established by the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. This is an established and accepted analytical method for measuring 13CO2 enrichment in breath.

7. The sample size for the training set:

   • The provided summary does not explicitly mention a separate "training set" for the device's development. This is typical for an analytical instrument where performance is often based on the device's physical and algorithmic design, rather than a machine learning model that requires a distinct training phase on clinical data. The clinical study described served as a validation/test set.

8. How the ground truth for the training set was established:

   • As no explicit training set is mentioned in the summary, this question is not directly applicable. If a training phase existed during device development, the ground truth would likely have been established through controlled experiments and calibrations using known standards for 13CO2 enrichment, analogous to the GIRMS method used for the clinical validation.

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The RLP-Cholesterol Assay is intended for use in the quantitative determination of cholesterol contained in remnant lipoproteins in human serum or plasma. The test results are used in combination with total serum triglyceride measurements to aids in the diagnosis of familial type III hyperlipoproteinemia in patients with serum total cholesterol concentration ≥ 200 mg/dL and triglyceride concentrations between 200 and 800 mg/dL.

The RLP-Cholesterol Assay uses two mouse monoclonal antibodies (Mab) to isolate remnant lipoproteins. The first one (JI-H) is raised against human apo B-100. This Mab recognizes an epitope near the apo B-51 region to remove lipoproteins containing apo B-100, such as LDL, Lp(a) and nascent VLDL. The second one (H-12) is raised against human apo A-I. This Mab removes lipoproteins containing apo A-I, such as HDL. The monoclonal antibodies are conjugated to sepharose-4B beads and to separate bound lipoproteins from the remnant lipoproteins that remain in the unbound fraction. Cholesterol in the unbound fraction (RLP-C) is then quantified by an enzymatic assay.

Here's an analysis of the acceptance criteria and study details for the RLP-Cholesterol Immunoseparation Assay, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RLP-Cholesterol Assay are primarily focused on its ability to accurately diagnose Type III hyperlipoproteinemia using the RLP-C to total TG ratio, comparing its performance against a laboratory reference method (ultracentrifugation) and a predicate device (REP Kit).

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Reference Range Study:
     • Test Set Size: 729 healthy volunteers.
     • Data Provenance: Not explicitly stated, but implied to be from a general population. Prospective (implied, as they "enrolled" volunteers).
   • Type IIb, III and IV Study:
     • Test Set Size: 62 subjects met inclusion criteria (24 Type III, 38 Type IIb or IV). For the diagnostic comparison, 51 subjects were analyzed (20 Type III, 31 non-Type III) who had total cholesterol > 200 mg/dL and TG between 200-800 mg/dL.
     • Data Provenance: Conducted at two centers specializing in familial lipid disorders. Implied to be prospective, as subjects were "enrolled." Country of origin not specified, but the submission is from Japan with an official correspondent in the US, suggesting international or US-based studies.
   • Clinical Utility Study:
     • Test Set Size: 724 subjects in total. 140 of these were hyperlipidemic (used for agreement analysis).
     • Data Provenance: Not explicitly stated but seemed to involve different subject groups (healthy, CAD, diabetes). Implied to be prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts or their qualifications for establishing the ground truth.
   • Ground truth for Type III hyperlipoproteinemia diagnosis was primarily established using:
     • Laboratory Reference Method: Ultracentrifugation (specifically VLDL-C to total TG ratio > 0.30 and presence of ß-VLDL). This is a well-established laboratory method using instrumental analysis, not solely expert interpretation.
     • Predicate Device: REP Kit (implies a comparison to its established diagnostic capability, which likely relied on visual patterns or quantitative results interpreted by laboratory personnel).
   • The "two centers specializing in familial lipid disorders" in the Type IIb, III, and IV Study suggest that qualified clinicians and laboratory professionals were involved in patient selection and ground truth determination, but specific expert count or qualifications aren't provided.

3. Adjudication method for the test set:

   • No specific adjudication method (e.g., 2+1, 3+1) is mentioned.
   • The ground truth relied on established laboratory methodologies (ultracentrifugation, predicate device results for comparison). For the Type IIb, III, and IV Study, the types of hyperlipoproteinemia were determined by these methods.

4. 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 MRMC comparative effectiveness study was done.
   • This device is an in-vitro diagnostic (IVD) assay that produces quantitative results, not an AI-powered image analysis or diagnostic assist tool for human readers. Therefore, the concept of "human readers improve with AI" does not apply here.

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

   • The RLP-Cholesterol Assay is inherently a "standalone" device in that it generates quantitative results (RLP-C values and RLP-C to total TG ratios) without human interpretation as part of its core function. Human clinicians then use these numerical results, in combination with other clinical findings, to make a diagnosis. The studies evaluate the analytical and diagnostic performance of the assay itself.

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

   • Primary Ground Truth: Established laboratory reference method, specifically ultracentrifugation, to determine VLDL-C concentrations and the presence of ß-VLDL, which are the gold standard for diagnosing Type III hyperlipoproteinemia.
   • Secondary Ground Truth/Comparator: Performance of a legally marketed predicate device (REP Kit).

7. The sample size for the training set:

   • The document implies that there was no distinct "training set" in the context of machine learning. This is an immunoassay device, not an AI/ML algorithm.
   • The "Reference Range Study" with 729 healthy volunteers helped establish a clinical cut-off value, which could be considered an initial calibration or parameter setting. The "Type IIb, III and IV Study" and "Clinical Utility Study" served as validation/test sets to demonstrate performance.

8. How the ground truth for the training set was established:

   • As there was no explicit "training set" for an AI/ML algorithm, this question isn't directly applicable.
   • For the "Reference Range Study," the 95th percentile of the RLP-C to total TG ratio from a large cohort of healthy volunteers was used to establish an initial cut-off. This is a statistical approach based on a healthy population, not a "ground truth" derived from expert labeling for individual cases. The diagnosis of hyperlipoproteinemia types in the Type IIb, III, and IV Study was based on the ultracentrifugation method.

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