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The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.

The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

The ACCU-CHEK Connect Diabetes Management App is designed to facilitate efficient collecting, transmitting, and analyzing of blood glucose results and other diabetes management data. The App helps:

• Wireless transfer of data from ACCU-CHEK Aviva Connect Blood Glucose Meter.
• Assist in general diabetes management through logging of contextual data.
• ACCU-CHEK Bolus Advisor support of mealtime insulin dosing calculations.
• Perform structured testing.
• Wireless transfer of data from mobile devices to ACCU-CHEK Connect Online Diabetes Management System and optionally share this data with healthcare provider (HCP) or caregiver.

The insulin bolus calculations provided by the app are meant for patients undergoing multiple daily injection therapy. Bolus calculators, such as the ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professional experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.

The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACCU-CHEK Connect Diabetes Management App, structured as requested:

Acceptance Criteria and Device Performance for ACCU-CHEK Connect Diabetes Management App

The provided FDA 510(k) summary (K141929) for the ACCU-CHEK Connect Diabetes Management App primarily focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Aviva Combo meter). While it mentions "performance requirements" and "algorithm validation," it does not explicitly state specific quantitative acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or precision) with corresponding reported device performance values in a table. Instead, it refers to a qualitative assessment that the device "meets the performance requirements for its intended use" and "demonstrated that the device functions as intended."

The document emphasizes that the Bolus Advisor algorithm within the app is "unchanged as compared to the predicate device." Therefore, the performance of the algorithm is implicitly tied to the cleared performance of the predicate.

Here's an attempt to structure the available information, noting the absence of explicit quantitative criteria in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document mentions "software testing and performance testing of the device" and a "Human Factors clinical study."

• Software and Performance Testing: No specific sample size (e.g., number of test cases, specific data points) is provided for the device's main software and performance testing.
• Human Factors Clinical Study: No specific sample size (e.g., number of participants) is provided for the "Human Factors clinical study."
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely that the studies were conducted with data relevant to the US market or in a manner acceptable to the FDA.

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

This information is not provided in the given document. The submission focuses on demonstrating substantial equivalence to a predicate device whose bolus calculation algorithm is adopted directly. The Human Factors study involved "persons with diabetes mellitus or their caregivers," but these are considered users, not experts establishing ground truth for algorithmic performance.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Given the nature of a software application for diabetes management and bolus calculation, adjudication might not be relevant in the same way it would be for diagnostic imaging where expert consensus is often used. For software functionality, ground truth often comes from predefined requirements and expected outputs based on established medical formulas.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided text. The device is a "Drug Dosing Calculator" and a "diabetes management app," not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. The document states that the Bolus Advisor algorithm is unchanged from the predicate device, implying that its effectiveness has already been established and accepted with that predicate. No effect size of human improvement with AI assistance is mentioned because this type of study was not conducted or reported.

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

Yes, implicitly, a standalone assessment of the algorithm was done. The document states: "The insulin bolus calculator algorithm is unchanged as compared to the predicate device." This means the algorithm's performance was previously validated in its standalone form within the predicate device (ACCU-CHEK Aviva Combo meter). The current submission leverages that prior validation. There's no new, separate standalone study explicitly described for the ACCU-CHEK Connect Diabetes Management App, beyond the confirmation that it uses the same algorithm.

7. The Type of Ground Truth Used

For the bolus calculation algorithm, the ground truth would be based on established medical formulas and diabetes management guidelines for insulin dosing and carbohydrate intake calculations. The accuracy of these calculations against the established formulas would have been the ground truth for the predicate device. For the ACCU-CHEK Connect App, the ground truth for its software functionality relies on validated software requirements and the expected output of its operations.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device. The ACCU-CHEK Connect Diabetes Management App, particularly its Bolus Advisor, is a rule-based system employing an "unchanged" algorithm from a predicate device. It is not an AI/Machine Learning model that would typically have a "training set" in the conventional sense. The algorithm is based on well-defined clinical parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, etc.) provided by a healthcare professional.

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

As noted above, this device does not appear to involve machine learning or AI that would require a "training set" with ground truth established through typical methods like expert annotation or pathology. The "ground truth" for the bolus calculation algorithm stems from established medical science and clinical practice guidelines for insulin dosing, which determine the correct output for given input parameters. The validation of such an algorithm would involve testing it against a wide range of clinically relevant scenarios, where the "correct" insulin dose is derived from these established medical principles.

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The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.

The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.

The ACCU-CHEK Aviva Expert System consists of the following which was originally cleared under K131366:

• ACCU-CHEK Aviva Expert meter
• ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter)
• ACCU-CHEK Aviva Plus test strips
• ACCU-CHEK Aviva control solutions

The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips and the ACCU-CHEK Aviva control solutions.

The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ration, and insulin sensitivity parameters.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance of the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system:

The document describes the ACCU-CHEK Aviva Expert Blood Glucose Monitoring system and refers to performance testing that was submitted and cleared under a previous 510(k) (K131366). The current submission (K142089) states that "The ACCU-CHEK® Aviva Expert System has not changed since this prior submission and the information submitted here is provided to support the clarification in the intended use statement." Therefore, the performance data presented is for the identical device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents performance data as evidence of the device meeting requirements for its intended use, but does not explicitly state predetermined "acceptance criteria" as separate rows. However, to construct a table, we can infer the acceptance criteria from the reported results, assuming the reported values met the relevant regulatory standards for blood glucose monitoring systems at the time of clearance.

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The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

The modified ACCU-CHEK Aviva meter used in conjunction with the ACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meter no longer uses a code key.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions

Here's an analysis of the provided text regarding the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System, focusing on acceptance criteria and study details.

Based only on the provided text, the specific details regarding the acceptance criteria and a detailed study proving the device meets them are very limited. The document is primarily a 510(k) summary for a modified device, emphasizing its substantial equivalence to a predicate device.

Here's what can be extracted and what is explicitly not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting performance requirements and being substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document only states "Performance testing on the ACCU-CHEK Aviva System demonstrated..."

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

This information is not provided in the given text. For blood glucose monitoring systems, ground truth is typically established using a high-precision laboratory reference method, not necessarily by human experts in the same way it would be for imaging diagnostics. The text does not elaborate on the method used to establish reference glucose values.

4. Adjudication method

This information is not provided in the given text.

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

• MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, which typically does not involve human "readers" interpreting results in the same way an imaging AI system would. Its primary function is to provide a quantitative measurement.
• AI Improvement Effect Size: Not applicable. There is no mention of AI integration in this blood glucose monitoring system.

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

The device itself is a standalone system in the sense that the meter provides the glucose reading without requiring human interpretation or intervention beyond performing the test procedure. However, the document does not distinguish between "standalone algorithm performance" and "system performance" as it might for an AI-driven diagnostic. The "performance testing" referred to would inherently be of the "algorithm only" (i.e., the device's measurement capability) without a human interpreting the result to determine the glucose level.

7. The type of ground truth used

The type of ground truth is not explicitly stated beyond the implication that it's a quantitative measurement of glucose. For blood glucose meters, the ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) known for its high accuracy. The text only mentions "quantitative measurement of glucose (sugar)."

8. The sample size for the training set

This information is not provided in the given text. Blood glucose meters are not typically "trained" in the same way a machine learning algorithm would be. Their performance is based on the chemical and electrical design of the test strip and meter. If any statistical models or calibrations were involved, the training set details are omitted.

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

This information is not provided in the given text. (See point 8 regarding "training set.")

Summary of Limitations due to Document Scope:

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device for a modified blood glucose monitoring system (specifically, a meter that no longer uses a code key). It states that performance testing was done and that the device "meets the performance requirements for its intended use" and is "substantially equivalent to the predicate device." However, it does not provide detailed technical specifications, exact acceptance criteria, or granular study results (like sample sizes for performance studies, specific ground truth methods, or any statistical analysis) that would be found in a full submission or a detailed study report. These details are often proprietary or contained in other sections of a 510(k) submission not included here.

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The Elecsys T4 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's a breakdown of the acceptance criteria and study information for the Elecsys T4 CalCheck 5, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Elecsys T3 CalCheck 5) rather than explicitly stating specific numerical acceptance criteria for the Elecsys T4 CalCheck 5. However, the performance characteristics section mentions "value assignment and stability" as evaluation points. From the comparison table with the predicate, we can infer some targets or expected ranges for "Check Target Values" and "Assay Measuring Range".

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The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.

Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test Accessory to direct the Tecan Genesis RSP 150 Workstation Urine specimens are not indicated for use with the automated sample preparation option.

Roche Scripts for AMPLICOR CT/NG Test: The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:

• AMPLICOR ® CT/NG test for Chlamydia trachomatis .
• AMPLICOR ® CT/NG test for Neisseria gonorrhoeae .

The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from sympotmatic males as evidence infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer.

The Roche Scripts for AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.

The document describes the AMPLICOR CT/NG test for Neisseria gonorrhoeae and the Roche Scripts for AMPLICOR CT/NG Test Accessory. The 'device' in question appears to be the Roche Scripts accessory which enables automated sample preparation for the existing AMPLICOR CT/NG test. The acceptance criteria and supporting studies focus on demonstrating that the automated sample preparation method (using the Roche Scripts) performs equivalently to the previously cleared manual sample preparation method.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets for the Roche Scripts accessory itself, but rather established through demonstrating equivalence to the performance of the predicate device (AMPLICOR CT/NG test for Neisseria gonorrhoeae with manual preparation). The acceptance is therefore implicitly based on demonstrating that the automated preparation method does not negatively impact the established performance characteristics.

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

• Analytical Sensitivity (Automated preparation): The document states "100 cfu/mL for CTM with swab specimen" without specifying the number of samples used to determine this.
• Precision (Automated preparation): "99.4% correct results for panels of CTM specimens" without specifying the number of CTM specimens or the total number of tests.
• Clinical Evaluation (Automated vs. Manual): The sample size for the clinical evaluation comparing automated and manual methods is not explicitly stated. The data provenance (country of origin, retrospective/prospective) is not specified. However, the study involved comparing results from the automated method to the manual method, implying existing clinical samples or prospectively collected samples analyzed by both methods.

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

Not applicable. This is an in vitro diagnostic device, and the ground truth for Neisseria gonorrhoeae infection is typically established via culture (a laboratory method), not by expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned or implied.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic device, the results are quantitative/qualitative outputs from the assay, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an in vitro diagnostic test system, not an AI-assisted diagnostic imaging or pathology tool involving human readers.

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

The device (Roche Scripts accessory) is essentially a standalone automation algorithm. Its performance is evaluated in a standalone manner by comparing its output (after automated sample prep) to the manual method's output. The "algorithm only" performance is represented by the "Automated preparation" columns in the table above and the clinical evaluation comparing automated vs. manual methods.

7. The Type of Ground Truth Used

For the original AMPLICOR CT/NG test (to which the new automated method is compared), the clinical performance ground truth was established "vs. culture." Culture is considered the gold standard for detecting viable Neisseria gonorrhoeae. For the evaluation of the Roche Scripts accessory, the "ground truth" for the clinical evaluation was implicitly the results obtained by the manual preparation method of the already cleared AMPLICOR CT/NG test, as the key objective was to show concordance.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that undergoes a 'training phase' in the traditional sense. The "Roche Scripts" are software instructions for a liquid handling system; they were "developed" but not "trained" on a dataset like an AI algorithm.

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 algorithm. If "training set" refers to samples used during the development and optimization of the scripts, this information is not provided. The document states "The Roche Scripts were developed and evaluated according to FDA Guidance evaluation documents." This implies standard software development and verification procedures.

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The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer.

Roche Scripts for AMPLICOR CT/NG Test: The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:

• AMPLICOR® CT/NG test for Chlamydia trachomatis
• AMPLICOR® CT/NG test for Neisseria gonorrhoeae

Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test accessory to direct the Tecan Genesis RSP 150 workstation. Urine specimens are not indicated for use with the automated sample preparation option.

The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer. The Roche Scripts for AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.

This document focuses on the AMPLICOR CT/NG test for Chlamydia trachomatis with optional Roche Scripts for AMPLICOR CT/NG Test Accessory. The primary purpose of the Roche Scripts accessory is to automate the specimen preparation procedure for the existing AMPLICOR CT/NG test. The study therefore aims to demonstrate that the automated preparation method yields equivalent performance to the manual preparation method for the detection of C. trachomatis.

Here's the breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative format with specific thresholds to be met. Instead, it states that the performance characteristics were "evaluated" and "results were equivalent to those obtained with manual specimen preparation." The table below summarizes the listed performance characteristics from the "Comparison - similarities" section, indicating that these were similar or equivalent to the predicate device, which used manual preparation. For the "Current Device (automated preparation)" column, the provided values are the reported performance characteristics where they differ or are newly reported for the automated process.

Note: The phrase "Results were equivalent to those obtained with manual specimen preparation" in the "Performance Evaluation" section suggests the overarching acceptance criterion was non-inferiority or equivalence to the established manual method.

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

The document does not explicitly state the sample size used for the clinical evaluation test set where the automated preparation method was compared to the manual method. It only states "A clinical evaluation was performed".

Data Provenance: The document does not specify the country of origin. It is a premarket notification to the FDA, suggesting the studies were conducted to support US regulatory approval. The studies are retrospective, comparing the automated preparation method with the established manual preparation method.

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

This information is not provided in the document. For diagnostic tests like this, the 'ground truth' for clinical samples would typically be established by culture or a combination of clinical diagnosis and other accepted laboratory methods, not usually by a panel of experts reviewing images or results. The analytical studies would have ground truth established by known concentrations of organisms.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication method" in the context of expert review. Clinical performance is assessed against a comparator (manual method and potentially culture), not through adjudicated expert consensus on each case.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic aids where human readers interpret results. The AMPLICOR CT/NG test is an in vitro diagnostic test that provides a qualitative (positive/negative) result; therefore, an MRMC study is not applicable. The comparison here is between two sample preparation methods for the same assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an in vitro diagnostic test for detecting DNA. The "Roche Scripts accessory" automates a part of the sample preparation process for an existing, already cleared assay. Therefore, the "algorithm" (scripts) performs an automated laboratory task, not an independent diagnostic interpretation that would involve a "human-in-the-loop" once the assay is run. The overall test is an "algorithm only" in the sense that the assay itself generates a direct result. The study effectively evaluated the standalone performance of the automated sample preparation system in generating results that are equivalent to manual preparation.

7. The Type of Ground Truth Used

For the analytical studies (analytical sensitivity, specificity, precision), the ground truth is established by known concentrations or presence/absence of C. trachomatis (or other organisms for specificity) in laboratory-prepared samples.

For the clinical evaluation, the ground truth for C. trachomatis infection status in patient samples is likely based on:

• Comparison to the manual preparation method of the AMPLICOR CT/NG test itself (labeled as "98.5% concordance with manual method"). This serves as a reference for equivalence, assuming the manual method's clinical performance is validated.
• The predicate device's clinical performance also references "Sensitivity vs. culture" and "Specificity vs. culture". This indicates that bacterial culture was a key ground truth method for validating the diagnostic accuracy of the PCR test itself.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is a premarket submission for an in vitro diagnostic (IVD) device, where the focus is on validation and verification of analytical and clinical performance through predefined studies, not typically on machine learning model training. The "Roche Scripts" are software for automation, not an AI/ML diagnostic algorithm that would require a distinct training phase.

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

As there is no distinct "training set" in the context of an AI/ML model for this IVD device (the scripts automate a lab process), the concept of ground truth for a training set does not directly apply here. The existing knowledge and performance characteristics of the manual AMPLICOR CT/NG test would have informed the development and optimization of the automated scripts to ensure equivalent performance.

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