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The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment. The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.

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The provided document is a 510(k) premarket notification approval letter for the Oxicare Fingertip Pulse Oximeter, Model DB12. It confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance. This document only confirms the device's substantial equivalence based on prior (unspecified) testing.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not typically for a simple pulse oximeter.
6. Information on standalone algorithm performance. A pulse oximeter is a physical sensor, not an algorithm in the sense of AI.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of the device's clearance, such as its classification, regulation number, and general controls provisions of the Act. While it implies that the device has undergone testing to demonstrate its performance for "spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR)", the details of how that performance was assessed against specific criteria are not included in this FDA letter. Such details would typically be found in the manufacturer's 510(k) submission, which is not fully provided here.

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DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm,). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The DA01 Blood Glucose Test Strips are used with the DA01 Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.

The DiaLife mini is a PC-based software intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The DiaLife mini software receives via USB, stores, and uses patient data for display and reporting. It is intended for use as an accessory to DELBio DA01 Blood Glucose Monitoring System.

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The provided text describes a medical device named the "DA01 Blood Glucose Monitoring System" and its regulatory clearance. However, it does not contain the detailed acceptance criteria and the study results as requested by the user.

The document is a 510(k) clearance letter from the FDA, indicating market clearance for the device based on substantial equivalence to existing predicate devices. It outlines the intended use, regulatory classification, and general information about FDA regulations. It does not include specific performance studies or acceptance criteria beyond stating that the device is for "quantitative measurement of glucose level."

Therefore, I cannot provide the requested information based on the given input.

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DiaTrue Plus Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample from the fingertip and the palm. The alternate site testing can be only used during steady-state blood glucose monitoring. The DiaTrue Plus Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The DiaTrue Plus Blood Glucose Test Strips are used with the DiaTrue Plus Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip and the palm.

The DiaTrue Glucose Control Solutions are for use with the DiaTrue Plus Blood Glucose Test Strips and the DiaTrue Plus Glucose meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.

The DiaLife Mini Blood Glucose Management Software is designed for use in the home with the DiaTrue Plus Blood Glucose Monitoring System to allow users to transmit data from meter to their computer. It is an optional data management software accessory for use with the DiaTrue Plus Blood Glucose Monitoring System.

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The provided text is a 510(k) premarket notification letter for the DiaTrue Plus Blood Glucose Monitoring System. It describes the device, its intended use, and the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to answer all parts of your request.

Specifically, the document refers to the submission as "premarket notification of intent to market" and states that "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent". This implies that the specific studies and data proving the device meets acceptance criteria are part of the detailed submission document (the 510(k) itself), which is not fully provided here.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance: This detailed information is not present. The document only states the device is "substantially equivalent" to predicate devices, implying that its performance is comparable, but does not provide the specific metrics or acceptance thresholds.
• Sample size used for the test set and data provenance: Not mentioned.
• Number of experts used to establish ground truth and qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study information: This type of study is typically for evaluating AI/CAD systems that assist human readers. A blood glucose monitor is a standalone diagnostic device, so an MRMC study is generally not applicable in this context. The document also does not mention any such study.
• Standalone (algorithm only) performance: While the device itself is standalone, the document doesn't provide specific performance metrics (e.g., accuracy, precision) that would be the output of a standalone performance study.
• Type of ground truth used: Not mentioned. For blood glucose meters, the ground truth is usually established by a highly accurate laboratory reference method.
• Sample size for the training set: Not mentioned. (Blood glucose meters are typically calibrated rather than "trained" in the machine learning sense, but the specific validation details are missing).
• How the ground truth for the training set was established: Not mentioned.

What the document does provide:

• Device Name: DiaTrue Plus Blood Glucose Monitoring System
• Indications for Use: Quantitative measurement of glucose level in fresh capillary whole blood from fingertip and palm by a single person at home to monitor diabetes control. Not for diagnosis, screening, or neonates.
• Regulatory Class: II
• Product Code: NBW, CGA, JJX, JQP
• Date of Submission: July 02, 2013
• Outcome: Substantially Equivalent determination by FDA.

To answer your request comprehensively, you would need to examine the full 510(k) submission for K130244, which would contain the detailed study reports and data.

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DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The DA01 Blood Glucose Test Strips are used with the DA01 Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.

The DA06 Glucose Control Solutions are for use with the DA01 Blood Glucose Test Strips and the DA01 Glucose Meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.

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Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the DA01 Blood Glucose Monitoring System, as best as can be extracted from the given document:

This document is primarily a 510(k) clearance letter from the FDA, and as such, it does not contain detailed information about the acceptance criteria and study results. It confirms that the device has been cleared for marketing based on a determination of substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and inferred:

Acceptance Criteria and Device Performance Study for DA01 Blood Glucose Monitoring System

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

Unfortunately, the provided FDA 510(k) clearance letter does not contain the specific acceptance criteria or the reported device performance data from the studies submitted by Delbio Incorporation. These details would typically be found in the original 510(k) submission document itself, not in the clearance letter.

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

• Test Set Sample Size: Not available in this document.
• Data Provenance: Not available in this document. (e.g., country of origin, retrospective/prospective)

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

Not available in this document. For a blood glucose monitoring system, the "ground truth" is typically established by a highly accurate laboratory reference method, not by human expert interpretation in the same way it would be for imaging studies.

4. Adjudication method for the test set

Not applicable/available. As mentioned above, for a glucose meter, adjudication by experts is not the standard method for establishing ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.

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

This refers to the performance of the device itself (the meter and test strips) in measuring glucose levels. While the clearance implies such studies were done to demonstrate accuracy against a reference method, the details of those standalone performance tests are not provided in this document. The device operates as a standalone measurement tool.

7. The type of ground truth used

For a blood glucose monitoring system, the ground truth would typically be established by a a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer or similar). This document does not explicitly state the reference method used.

8. The sample size for the training set

Not applicable/available. For a hardware device like a blood glucose meter, the concept of a "training set" as understood in machine learning is not directly relevant. Performance is demonstrated through analytical and clinical studies on its accuracy and precision.

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

Not applicable. See point 8.

Summary of what can be gleaned from the document:

• Device Name: DA01 Blood Glucose Monitoring System
• Intended Use: Quantitative measurement of glucose level in fresh capillary whole blood samples (finger and palm) for in vitro diagnostic use, at home, by a single person.
• Purpose: As an aid in monitoring the effectiveness of diabetes control programs.
• Limitations: Not for diagnosis or screening of diabetes, nor for testing neonates. Alternate site testing only during steady-state blood glucose monitoring.
• Regulatory Class: Class II
• What this document does convey: The FDA found the device substantially equivalent to a predicate device, allowing it to be marketed. This determination implies that Delbio Incorporation submitted data (including performance studies) that met FDA requirements for substantial equivalence, but the details of those studies are not in this letter.

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The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control and should not be shared. The device should not be used for screening or diagnosis of diabetes or for testing neonates.

The DiaTrue Plus Blood Glucose Meter is intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control.

The DiaTrue Plus Blood Glucose Test Strips are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Blood Glucose Test Strips must be used with the DiaTrue Plus Blood Glucose Meter. Testing is done outside the body. They are indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control.

DiaTrue Glucose Control solution: For use with DiaTrue Blood Glucose Meter and DiaTrue Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Three levels of control solution are provided: Level I, Level II and Level III.

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This document is a 510(k) clearance letter for the DiaTrue Plus Blood Glucose Monitoring System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. The provided text only indicates that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot answer your request based on the provided input.

Ask a specific question about this device

DiaCheck Smart Blood Glucose Monitoring System: The DiaCheck Smart Blood Glucose Monitoring System is intended for the quantitative rno Blacmost of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Smart Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Smart Blood Glucose Test Strips: The DiaCheck Smart Blood Glucose Test Strips are for use with the DiaCheck Smart Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

DiaCheck Superior Blood Glucose Monitoring System: The DiaCheck Superior Blood Glucose Monitoring System is intended for the rne Black our of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Superior Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Superior Blood Glucose Test Strip: The DiaCheck Superior Blood Glucose Test Strips are for use with the DiaCheck rne Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

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Please note that the provided document is a 510(k) clearance letter from the FDA, not a full study report or clinical trial documentation. Therefore, much of the detailed information typically found in such reports (like sample sizes for specific training/test sets, expert qualifications, adjudication methods, or MRMC study results) is not present. This letter primarily focuses on the FDA's determination of substantial equivalence based on the submitted materials, rather than providing a detailed breakdown of the underlying studies.

However, I can extract the acceptance criteria and the reported performance as presented in this document, and infer what can be from the context.

Acceptance Criteria and Device Performance for Glucose Test System

The DiaCheck Smart Blood Glucose Monitoring System and DiaCheck Superior Blood Glucose Monitoring System are intended for quantitative measurement of glucose in fresh capillary whole blood samples from fingertips. Based on the provided FDA 510(k) clearance, the acceptability of the device is determined by its substantial equivalence to legally marketed predicate devices, implying that its performance meets the regulatory standards for accuracy and reliability established for such systems.

The specific acceptance criteria for blood glucose monitoring systems typically involve accuracy metrics compared to a laboratory reference method. While these exact criteria are not explicitly detailed in the FDA clearance letter, common standards (e.g., ISO 15197) for blood glucose meters require that for glucose concentrations ≥ 4.2 mmol/L (75 mg/dL), 95% of the measured values should fall within ±15% of the reference value, and for glucose concentrations

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The Diacheck Premium Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Diacheck Premium Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

The Diacheck Premium Blood Glucose Test Strips are for use with the Diacheck Premium Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The test strip is intended for self testing outside the bod (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

The Diacheck Control solutions are intended for use with Diacheck Premium Blood Glucose Meter and Diacheck Premium Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

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The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the DiaCheck Premium Blood Glucose Monitoring System.

The document is a 510(k) premarket notification letter from the FDA to DELBio Incorporation, confirming that their DiaCheck Premium Blood Glucose Monitor System is substantially equivalent to legally marketed predicate devices. It also includes the "Indication for Use" for the device, test strips, and control solution.

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

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