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CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine. These metabolites are useful in the evaluation of renal, urinary and metabolic disorder.

CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine.

Here's an analysis of the provided text regarding the CHEMVIEW-10™ Urinalysis Test Strips, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study aims to demonstrate "substantial equivalence" to the predicate device (Roche Chemstrip®) through high agreement percentages. The reported device performance is presented as the agreement with the predicate.

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

• Sample Size for Test Set: A total of 188 specimens were tested.
• Data Provenance: The comparison studies were conducted at three reference laboratories. The specimens included "Fresh Urine specimens submitted to the laboratories for urinalysis as well as spiked urine specimens." This indicates a mix of naturally occurring clinical samples and possibly artificially altered samples, and the study is prospective in nature, as specimens were tested simultaneously with both devices. The country of origin is not explicitly stated, but the company is in Morganville, NJ, USA, and the FDA review is for the US market, suggesting data是从美国收集的.

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

The text does not specify the number of experts used to establish the ground truth or their qualifications. The comparison is made against the Roche Chemstrip® urinalysis reagent test strips, which itself serves as a reference, rather than an independent expert reading of a gold standard.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. The performance is reported as a direct agreement between the "CHEMVIEW-10™" and the "Roche Chemstrip®" results. There's no mention of multiple readers or steps to resolve discrepancies.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a visual, qualitative, and semi-quantitative test strip, not an AI-assisted diagnostic device where human readers interact with AI. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable as the CHEMVIEW-10™ is a visual test strip designed for human interpretation, not an algorithm. Therefore, "algorithm only without human-in-the-loop performance" doesn't fit the context of this device. The performance data is essentially the "standalone" performance of the test strip when read by a human.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device, Roche Chemstrip® urinalysis reagent test strips. The study establishes substantial equivalence by comparing results from the CHEMVIEW-10™ to those from the legally marketed predicate device.

8. The Sample Size for the Training Set

The text does not mention a separate training set. This is a traditional device comparison study and not an AI/machine learning study that typically involves training sets. The 188 specimens appear to be the only dataset described for performance evaluation.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or applicable in this context, the method for establishing its ground truth is not provided.

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Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

ACCUNATE™ONE-STEP, ACCUNATE™ONE-STEP CASSETTE and ACCUNATE-CHOICE™ are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine or in urine and serum for the early detection of pregnancy.

Here's a breakdown of the acceptance criteria and study information for the ACCUNATE series of pregnancy tests, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" as a separate, defined section with numerical targets. Instead, the studies aim to demonstrate "substantial equivalence" of the new devices to existing predicate devices. The performance metrics are relative to these predicates and directly inform the claim of equivalence.

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

• ACCUNATE™ONE-STEP & ACCUNATE™ONE-STEP CASSETTE:
  • Sample Size: 131 urine specimens.
  • Data Provenance: Prospective. Specimens were from "patients seeking confirmation of pregnancy" and tested simultaneously with the devices and predicate. The study was conducted at "three clinic sites," implying a likely domestic (USA) origin given the context of a US regulatory submission.
• ACCUNATE-CHOICE™:
  • Sample Size: 119 serum specimens.
  • Data Provenance: Prospective. Specimens from "normal male and non pregnant females" were tested simultaneously. The study details are similar to the above, suggesting a domestic (USA) origin.
• Sensitivity Testing:
  • Sample Size: 20 urine specimens and 20 serum specimens for each hCG concentration (0, 5, 25, 50, 100 mIU/ml). This means a total of 100 urine samples and 100 serum samples were tested across the concentrations.
  • Data Provenance: Controlled laboratory spike study. No geographic origin specified, but likely conducted internally or at a contract lab.
• Home User Study (ACCUNATE™ HOME PREGNANCY TEST):
  • Sample Size: 107 participants/samples.
  • Data Provenance: Prospective. Conducted at "three clinic sites," with participants being home users testing their own urine. Likely domestic (USA).

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

The studies rely on the performance of predicate devices (Abbott Test Pack Plus™ and Quidel's Quick-Vue®) as the de facto "ground truth" for comparative effectiveness. These devices are established, legally marketed pregnancy tests.

For the home user study, the "ground truth" was established by laboratory professionals using the ACCUNATE™ ONE-STEP CASSETTE. The qualifications of these professionals are not explicitly stated (e.g., "radiologist with 10 years of experience"), but it is implied they are trained and experienced in performing such clinical laboratory tests. There's no mention of a specific number of experts beyond "the laboratory."

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparisons are based on direct agreement with the predicate devices' results or the laboratory results in the home user study. Discrepancies, especially in the home user study, are noted (e.g., one home invalid result not found by the lab), but no formal adjudication process for such discrepancies is detailed in the summary. For the comparative studies, 100% agreement means no discrepancies requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No formal MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is measured. These studies are focused on the standalone performance of the devices and their agreement with predicate devices or a professional laboratory reference.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The entire set of studies focuses on the device's performance as a standalone test, without human interpretation influencing the primary result (though humans obviously perform the test and read the result). The "100% agreement" and "25 mIU/ml sensitivity" directly reflect the standalone performance of the ACCUNATE devices.

7. Type of Ground Truth Used

• Comparative Studies (with Abbott Test Pack Plus™ and Quidel's Quick-Vue®): Predicate device results. This is a common approach for demonstrating substantial equivalence for new diagnostic devices. The assumption is that the predicate device's results are accurate and serve as the clinical reference.
• Sensitivity Study: Laboratory-prepared spiked samples with known concentrations of hCG. This is a controlled, objective ground truth for measuring the detection limit.
• Home User Study: Laboratory professional results using a comparable ACCUNATE™ device (ACCUNATE™ ONE-STEP CASSETTE). This serves as the expert reference for evaluating home user accuracy.

8. Sample Size for the Training Set

The document does not mention any "training set." These devices (lateral flow immunoassays) are not AI/algorithm-based devices that typically require training data. Their performance is inherent to their chemical and physical design.

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

As there is no mention of a training set, this question is not applicable.

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ACCUNATE™-ONE STEP and ACCUNATE™-ONE STEP CASSETTE are rapid lateral flow colloldal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

ACCUNATE™-ONE STEP and ACCUANTE™-ONE STEP CASSETTE are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.

The acceptance criteria and study proving the device meets them are as follows:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Comparison Study:
  • Sample Size: 131 urine specimens.
  • Data Provenance: Not explicitly stated, but implies prospective collection as specimens were "from patients seeking confirmation of pregnancy" and tested "simultaneously" at three clinic sites. The country of origin is not specified, but the applicant and testing sites are located in the US.
• Sensitivity Study:
  • Sample Size: 20 urine specimens from normal males and non-pregnant females for each hCG concentration (0 IU/ml, 5 mIU/ml, 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml), totaling 100 tests.
  • Data Provenance: Retrospective, as urine specimens were "spiked with hCG". The country of origin is not specified.

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

• Comparison Study: The ground truth for the comparison study appears to be established by the results of the predicate device, the Abbott Test Pack Plus™. No information is provided on the number or qualifications of experts involved in determining the "true" positive or negative status of the samples beyond the predicate device's results.
• Sensitivity Study: For the sensitivity study, the ground truth was established by the known concentration of spiked hCG. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set:

• Comparison Study: Not explicitly stated. The document implies a direct comparison of results between the investigational devices and the predicate device. With 100% agreement, there was no need for adjudication of discordant results.
• Sensitivity Study: Not applicable, as the ground truth was based on known hCG concentrations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This device is a qualitative in vitro diagnostic test, not an imaging or diagnostic AI tool requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the studies presented are standalone evaluations of the device's performance. Both the comparison study and the sensitivity study assessed the ACCUNATE™-ONE STEP devices' ability to detect hCG in urine without human interpretation influencing the final result beyond observing the test line.

7. Type of Ground Truth Used:

• Comparison Study: The ground truth was based on the results of a legally marketed predicate device, the Abbott Test Pack Plus™.
• Sensitivity Study: The ground truth was based on artificially created samples with known concentrations of hCG (spiked urine specimens).

8. Sample Size for the Training Set:

• This information is not provided. The 510(k) summary describes performance studies, not the development or training of an algorithm. Given the simplicity of the test type (lateral flow immunoassay), it is unlikely there was a "training set" in the sense of a machine learning algorithm. The "training" would be more akin to internal R&D and optimization of reagents and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as a training set in the context of an algorithm or machine learning is not mentioned or relevant for this type of device submission.

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