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The Prodigy™ Thrombectomy System is intended for the removal and thrombi and thrombi from vessels of the peripheral arterial and venous systems.

Not for use in the coronaries, pulmonary vasculature, or the neurovasculature

The Prodigy™ Thrombectomy System is designed to remove thrombus from the vasculature using aspiration. The Prodigy™ Thrombectomy System is comprised of several components including:

• . Prodigy™ Catheter
• . Prodigy™ Twist
• . Prodigy™ Hotshot™ Controller
• TRUVIC Generator
• TRUVIC Canister
• . TRUVIC Tubeset

The single-lumen Prodigy™ Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The wire-based Prodigy™ Twist utilizes a soft, flexible polymeric tip to facilitate thrombus removal through the Prodigy™ Catheter as needed. The Prodigy™ Catheter is available in multiple diameters and both the Prodigy™ Catheter and Prodigy™ Twists are available in multiple effective lengths and are visible under fluoroscopy via radiopaque marker bands.

The Prodigy™ Hotshot™ Controller connects the Prodigy™ Catheter to the TRUVIC Generator and provides the user with the ability to control aspiration flow and visualize the extracted thrombus.

The provided text does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of a medical device cleared through a 510(k) submission.

The document is an FDA 510(k) clearance letter for the Prodigy™ Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them in the way one might expect for a de novo submission or a clinical trial for a novel device.

The "Non-Clinical testing / Performance Data" section (page 5) lists various tests performed, such as "Visual and Dimensional Verification," "Kink / Bend / Flex Verification," and "Simulated Use Performance Validation." It states, "The in vitro bench tests demonstrated that the Prodigy™ Thrombectomy System met all acceptance criteria and performed similarly to the predicate device." However, it does not explicitly state what those acceptance criteria were (e.g., a specific tensile strength value or a kink angle). It only broadly claims they were met.

Similarly, the "IN-VIVO GLP PRE-CLINICAL TESTING / PERFORMANCE DATA" section (page 6) mentions an animal study where "All acceptance criteria passed." Again, the specific acceptance criteria are not detailed.

Therefore, I cannot provide the requested table or answer most of the numbered questions because the specific acceptance criteria and detailed study results demonstrating their fulfillment are not present in this document.

To clarify, if the document had included a table like:

...and then described the study (e.g., "A total of 10 samples were tested in a controlled lab environment according to ASTM FXXXX standard..."), I would be able to populate the requested information. However, this level of detail is absent.

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Prodigy® Astro 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, palm, calf or thigh. The Prodig® Astro Blood Glucose Monitoring System is intended to be used in the home by a single person and should not be shared. The Prodigy® Astro 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 Prodigy® Astro Blood Glucose Monitoring System should not be used for the diagnosis of, or screeming for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). PRODIGY No Coding Test Strips are intended for use with the PRODIGY Astro blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home.

Prodigy® Astro PRO 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, palm, calf or thigh. The Prodigy® Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use by healthcare professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The Prodigy® Astro PRO Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

PRODIGY PRO No Coding Test Strips are intended for use with the PRODIGY Astro PRO blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system should only be used with single-use, auto-disabling lancing devices.

The Prodigy Astro Blood Glucose Monitoring System and the Prodigy Astro PRO Blood Glucose Monitoring System are identical devices (hereafter both are called the System), but the latter is claimed to be used not only in the home by a single person but also in professional healthcare settings.

The System consists of a meter and Prodigy No Coding Test Strips (or Prodigy PRO No Coding Test Strips). The System utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The System is also marketed as a meter kit with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution.

The Prodigy No Coding Test Strips utilizes the active enzyme, Glucose Oxidase, derived from Aspergillus niger.

Here's a breakdown of the acceptance criteria and study information for the PRODIGY Astro Blood Glucose Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents acceptance criteria within the study result descriptions. The table below consolidates this information.

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The PRODIGY iConnect 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, palm, calf or thigh. The PRODIGY iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect 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 PRODIGY iConnect 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).

PRODIGY No Coding Blood Glucose Test Strips are intended for use with the PRODIGY iConnect blood glucose meter to measure the concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm. upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only). Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY No Coding Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.

The system is intended for use at home for single patient use. It should not be used for the diagnosis of diabetes or for the testing of newborns. It consists of three main components, i.e., iConnect blood glucose meter, PRODIGY No Coding Blood Glucose Test Strips and 2 levels of Prodigy control solutions (Level 1 & Level 2). The physical components of the meter are Housing, PCBA, LCD and Ear phone jack. The PRODIGY No Coding Blood Glucose Test Strips are not coded. The device has the function of alternative sites testing at Finger, Palm, Forearm, Upper arm, Calf and Thigh.

The system has the ability of physically connecting to mobile devices for the purpose of obtaining blood glucose determination via a mobile APP.

The PRODIGY iConnect Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, and Warranty Card. The PRODIGY iConnect Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Meter User Guide, Quick Reference Guide, Logbook, Warranty Card, Prodigy Lancing Device, Prodigy Lancets, PRODIGY No Coding Blood Glucose Test Strips, and PRODIGY Control Solution.

Here's a breakdown of the acceptance criteria and the study information for the PRODIGY iConnect Blood Glucose Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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Prodigy® AutoCode® Eject 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, palm, calf or thigh. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Prodigy® AutoCode® Eject 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 Prodigy® AutoCode® Eject Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

PRODIGY® No Coding Test Strips are intended for use with the PRODIGY® AutoCode® Eject blood glucose meter to measure the concentration of the blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only) . Do not use them for diagnosis of, or screening for dabetes or for testing on neonates. PRODIGY® No Coding Test Strips are used as an aid to monitor the effectiveness of diabetes control.

This system contains a speaking function, but is not intended for use by the visually impaired.

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card.

The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution.

The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System has a speaking function.

The provided text describes the Prodigy® AutoCode Eject TM Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not contain the detailed study information (sample sizes, expertise, ground truth establishment) typically associated with acceptance criteria for an AI/ML medical device submission.

The document is a 510(k) summary for an in vitro diagnostic (IVD) device, specifically a blood glucose monitoring system, which measures glucose using an electrochemical method. These devices are generally tested against analytical and clinical performance standards rather than requiring AI-specific study designs like MRMC studies.

Here's a breakdown of the available information, noting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the format of a table with specific thresholds for accuracy, precision, sensitivity, or specificity. Instead, it relies on demonstrating substantial equivalence to a predicate device (PRODIGY Preferred® Blood Glucose Monitoring System, K122338) that has already met regulatory requirements.

The "Synopsis of Test Methods and Results" section generally states that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA." This indicates that standard analytical and clinical performance studies for blood glucose meters were conducted, but the specific results or acceptance criteria are not detailed in this summary.

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

This information is not provided in the document. The 510(k) summary only mentions that "Pre-clinical and clinical data are employed," but does not detail the sample size for any test sets or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer), not through expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective data (e.g., medical images) where human agreement is required to establish ground truth. For quantitative measurements like blood glucose, adjudication is not typically relevant at the point of establishing ground truth against a reference method.

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 or at least not reported in this 510(k) summary. These studies are specific to AI/ML devices that assist human readers in tasks like image interpretation. The Prodigy® AutoCode Eject TM Blood Glucose Monitoring System is a standalone diagnostic device that provides a direct quantitative measurement of glucose, not an AI assistant for human interpretation. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable.

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

The device itself is a standalone diagnostic device; its performance is inherently "algorithm only" in the sense that it measures glucose and provides a numerical output. However, it's not an AI/ML algorithm in the modern sense that often implies learning from data. It's an electrochemical system. The performance studies for such a device would inherently be standalone, evaluating the accuracy and precision of the meter and test strips.

7. The Type of Ground Truth Used

While not explicitly stated in this summary, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in clinical laboratories. This is a form of "objective measurement" or "pathology/reference method" rather than expert consensus or outcomes data.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The Prodigy® AutoCode Eject TM Blood Glucose Monitoring System is an electrochemical system, not an AI/ML device that requires a "training set" in the machine learning sense. Its underlying principle is a chemical reaction that generates an electrical current proportional to glucose, not a model trained on data.

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

This information is not provided and is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

In summary, the provided document describes a traditional in-vitro diagnostic blood glucose meter. The request for information regarding AI/ML-specific study design elements (MRMC, training sets, number of experts, adjudication) is not directly addressed because the device is not an AI/ML medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device by showing similar indications for use, technological characteristics, and comparable safety and effectiveness through "pre-clinical and clinical data" (analytical and clinical performance studies, which are not detailed in this summary).

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The Prodigy Choice 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, palm, upper-arm, calf or thigh. The Prodigy Choice Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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

The Prodigy Choice Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The Prodigy Choice Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Choice Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilize the enzyme glucose oxidase, which is derived from recombinant protein derived from the fungus Aspergillus niger.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Prodigy Choice Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative table format. It refers to compliance with ISO and NCCLS standards but doesn't detail the specific performance thresholds required by those standards, nor does it present the device's performance against them directly within the summary.

Here's a table based on the information that is available:

Note: Since specific numerical acceptance criteria and direct performance metrics are not provided in the 510(k) summary, this table relies on the general statement that the device "was tested to the required standards" and "complies." Detailed performance data would typically be found in the actual test reports submitted to the FDA, which are not part of this summary.

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

The provided 510(k) summary does not specify the sample size for the test set used in the performance testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the 510(k) summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference laboratory instrument's measurement of glucose in blood samples.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). For a blood glucose meter, which provides a direct quantitative measurement, an MRMC study is generally not applicable or mentioned. The provided text does not indicate that such a study was performed.

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

The device is a "Blood Glucose Monitoring System" which includes a meter and test strips. Its performance is inherently standalone in the sense that it provides a direct measurement without human interpretation of its output. The summary does describe "Performance Testing" to required standards, which implicitly refers to the standalone performance of the system.

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods for glucose measurement, which are considered highly accurate and precise. While not explicitly stated in the summary, this is the standard practice for validating such devices. The summary implicitly refers to this by mentioning compliance with standards like ISO 15197 and NCCLS EP9-A, which define acceptable accuracy against reference methods.

8. The Sample Size for the Training Set

For a blood glucose meter, there isn't typically a "training set" in the sense of a machine learning algorithm being trained on a dataset. The device uses an "electrochemical method-based meter and dry reagent biosensor" which operates on established chemical principles, not machine learning. Therefore, a training set is not applicable or mentioned.

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

As explained above, a "training set" is not applicable for this type of device.

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The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data.
The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.

The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL Server 2005 Server 2005.

Here's a breakdown of the acceptance criteria and study information for the Prodigy® Diabetes Management Software, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided document, primarily a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative or qualitative "acceptance criteria" and then directly reporting performance against them in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by the features and functionalities deemed necessary to be equivalent to the predicate device. The "reported device performance" is largely qualitative, indicating that these functionalities are present and work.

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

The document mentions a "clinical usability study" or "Human Factor Study" but does not specify the sample size used for the test set.

The data provenance is not specified (e.g., country of origin). It can be inferred that the study was prospective, as it was conducted "to verify ease of use and label comprehension" for the device being submitted.

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

The document does not specify the number of experts or their qualifications, nor does it explicitly mention "ground truth" in the context of expert review for the usability study. The usability study would typically involve end-users, not necessarily experts for ground truth establishment.

4. Adjudication Method for the Test Set

The document does not provide any information regarding an adjudication method for the test set.

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. The performance data section only mentions a "clinical usability study" or "Human Factor Study" to verify ease of use and label comprehension. This type of study is not an MRMC comparative effectiveness study, and there is no mention of comparing human readers with and without AI assistance, nor any effect size.

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

The device is described as "software management system" and "data management tool" for blood glucose monitoring data. Its primary function is displaying, storing, processing, reporting, and printing data from a blood glucose meter. It is not an AI algorithm performing diagnostic tasks in a standalone manner where performance metrics like sensitivity/specificity for a diagnosis would be relevant. The "performance data" refers to a usability study, not a standalone algorithmic performance test. Therefore, a standalone algorithmic performance study in the typical sense for an AI diagnostic device was not conducted or is not applicable to this type of device.

7. The Type of Ground Truth Used

For the "clinical usability study," the "ground truth" would implicitly be the successful and intuitive completion of tasks by the study participants and their feedback on ease of use and comprehension, as measured against predefined usability criteria. It's not a "ground truth" derived from expert consensus, pathology, or outcomes data, as those are typically associated with diagnostic or image analysis devices.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is a data management software, not a machine learning or AI model that requires a "training set" in the conventional sense.

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

Since there is no mention of a training set for an AI/ML model, there is no information on how ground truth for a training set was established.

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The 37-5 is a multi-purpose fluid management system indicated for the following:

• Laparoscopy: warming fluids for irrigation and aspiration .
• Hysteroscopy: uterine distention during diagnostic and operative procedures .
• Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional . fluid warming)
• Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic . and operative procedures

During hysteroscopic, cystoscopic and arthroscopic procedures, the 37~5 can be used to monitor fluid deficit.

The Thermedx 37-5 is a general purpose fluid management system intended for standard surgical fluid management applications. The device consists of a Base Unit and Disposable Tubing Sets. A rolling standmounted device houses infrared fluid heating technology and a peristaltic fluid pump with closed-loop controls. The unit operates in 2 primary modes with fluid heating; flow control and pressure control. The Disposable Tubing Sets include IV bag spike, heating cartridge, and trumpet valve or luck connectors for endoscopes or other devices.

Here's a breakdown of the acceptance criteria and study information for the Thermedx 37-5 Fluid Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with specific numerical acceptance criteria (e.g., target temperature ranges, flow rates with specific tolerances, pressure ranges with specific accuracies) or detailed numerical performance results for the Thermedx 37-5. Instead, it makes a general statement about meeting specifications.

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

• Sample Size for Test Set: Not specified. The document mentions "non-clinical performance testing" which typically involves a series of tests, but not a "sample size" in the statistical sense of a patient cohort. The tests are simulated, indicating no human or animal subjects were used.
• Data Provenance: Not applicable, as the testing was "non-clinical" and "simulated." This would imply in-house laboratory testing rather than data from a country of origin or retrospective/prospective studies on patients.

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

There is no mention of experts being used to establish a "ground truth" in the context of this 510(k) summary. The testing conducted was non-clinical and simulated, implying engineering and technical validation against pre-defined specifications rather than expert clinical judgment.

4. Adjudication Method for the Test Set

Not applicable. As no expert ground truth or clinical data requiring adjudication is mentioned, no adjudication method was used.

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

No. An MRMC study is not relevant for this type of medical device (fluid management system) which does not involve image interpretation or diagnostic performance that would require human readers. The document details performance testing of the device's physical functions.

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

This question is not directly applicable in its typical sense for an AI/algorithm-based diagnostic device. However, the "non-clinical performance testing" described (simulated laparoscopy, uterine distension, over-temperature, etc.) is standalone device performance testing, as it assesses the device's functions without direct human intervention in its operation for the purpose of the test. The device itself is designed to be used with human operators in a clinical setting.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined performance specifications and safety standards. For instance:

• Temperature accuracy (e.g., maintaining fluid at approximately body temperature).
• Pressure limits (e.g., maintaining pressure within safe ranges).
• Flow rates (e.g., meeting specified flow capabilities).
• Electrical safety standards (IEC 60601-1).

The device was tested against these pre-defined engineering and safety specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical/electronic fluid management system, not an AI/machine learning algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this device.

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The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Prodigy™ NPWT System, Model: Prodigy™ 800V). It confirms the device's substantial equivalence to a legally marketed predicate device.

Unfortunately, this document does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The letter focuses on regulatory approval based on equivalence, not on a detailed performance study report. Therefore, I cannot extract the requested information from this text.

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The Prodigy Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Prodigy Voice Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

This system contains speaker function which provides step by step instructions.

The provided text offers minimal details regarding the acceptance criteria and the study that proves the device meets those criteria. Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide specific acceptance criteria (e.g., accuracy percentages, precision metrics, bias limits) nor detailed performance results to populate such a table.

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

• Test Set Sample Size: Not specified.
• Data Provenance: The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." There is no mention of the country of origin or whether the studies were retrospective or prospective.

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

Not specified. The document only mentions "healthcare professionals" conducted studies.

4. Adjudication Method for the Test Set:

Not specified.

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

Not mentioned or implied. The focus appears to be on the device's standalone performance rather than comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):

Yes, this was undoubtedly done. The "Performance Studies" section states, "The performance of Prodigy Voice Blood Glucose Monitoring System was studied in the laboratory and in clinical settings..." This implies the device was tested as a standalone system.

7. Type of Ground Truth Used:

While not explicitly stated, for a blood glucose monitoring system, the ground truth would typically be established by a reference method (e.g., a laboratory-grade blood glucose analyzer that is traceable to an international standard). The text mentions "quantitative measurement of glucose," which necessitates a highly accurate reference for comparison.

8. Sample Size for the Training Set:

Not specified.

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

Not specified.

Summary of Available Information from the Provided Text:

• Reported Device Performance: NOT DETAILED. No specific metrics (e.g., accuracy, precision) or numerical results are provided. |
  | Test Set Sample Size | NOT SPECIFIED. |
  | Data Provenance (Test Set) | "in the laboratory and in clinical settings by healthcare professionals and lay users."
• Country of Origin: Not specified.
• Retrospective/Prospective: Not specified. |
  | Number & Qualifications of Experts (Ground Truth - Test Set) | NOT SPECIFIED. Mentions "healthcare professionals" but no details on number, specialties, or experience. |
  | Adjudication Method (Test Set) | NOT SPECIFIED. |
  | MRMC Comparative Effectiveness Study | NO. Not mentioned or implied. |
  | Standalone Performance | YES. Implied by "Performance Studies... in the laboratory and in clinical settings." |
  | Type of Ground Truth Used | Reference Method (e.g., laboratory-grade glucose analyzer). While not explicitly named, the nature of glucose measurement requires a highly accurate and precise reference method for comparative ground truth. |
  | Training Set Sample Size | NOT SPECIFIED. |
  | How Ground Truth for Training Set Was Established | NOT SPECIFIED. |

Conclusion:

The provided 510(k) summary (a premarket notification for demonstrating substantial equivalence to a predicate device) is high-level. It confirms that performance studies were conducted and that the device met its intended use, which is sufficient for 510(k) clearance. However, it does not provide the detailed scientific and clinical evidence, including specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would typically be contained in the full submission to the FDA. The purpose of this summary is to briefly introduce the device and its regulatory status, not to serve as a comprehensive research paper.

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