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510(k) Data Aggregation
(191 days)
IN-LINE DIAGNOSTICS CORP.
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(28 days)
IN-LINE DIAGNOSTICS CORP.
The CRIT-LINE MONITOR III, (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
Here's an analysis of the provided text regarding the CRIT-LINE MONITOR III, structured to answer your questions:
Acceptance Criteria and Device Performance Study for CRIT-LINE MONITOR III
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Device Performance (Reported Result) |
|---|---|
| Correlation coefficient value near 1 (i.e., .90 or greater) for internally calculated ABF vs. externally calculated ABF. | Correlation coefficient: 0.94 |
| - | Average difference between methods: 46 ml/min |
| - | Standard deviation of difference: 200 ml/min |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 29 data points
- Data Provenance: Retrospective (though collected specifically for this validation, it's not a prospective interventional trial based on the description).
- 16 data points from Victoria Hospital in London Ontario, Canada (April 8th and April 9th, 1999)
- 13 data points from Central Valley Dialysis in Salt Lake City, Utah (June 22nd and June 24th, 1999)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth. The "ground truth" (or reference method) was established by calculating Access Blood Flow (ABF) values externally using CRIT-LINE MONITOR III hematocrit measurements fed into a formula via a calculator or spreadsheet program (which was the previously approved method, K982412).
4. Adjudication Method for the Test Set
No adjudication method is described. The comparison was statistical between two calculated values (one internally by the device, one externally using device-generated hematocrit data and a formula).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a monitor measuring physiological parameters; it's not an AI system for image interpretation or diagnosis that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a way. The study's purpose was to validate the internal calculation of ABF by the CRIT-LINE MONITOR III. This internal calculation is essentially the "algorithm only" performance, compared against the established external calculation method which uses data generated by the same device (CLM III hematocrit measurements) but processes it outside the device. The study is evaluating the device's self-contained ABF calculation capability.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" was the previously approved method of ABF measurement, which involved:
- Measuring hematocrit values using the CLM III.
- Calculating ABF values externally via a calculator or spreadsheet program using these measured hematocrit values.
- This method itself had a 510(k) clearance (K982412).
Essentially, the ground truth was a reference calculation method using device-generated data.
8. The Sample Size for the Training Set
The document does not mention a separate training set. The CRIT-LINE MONITOR III is a physical device with a software modification for internal calculation. The description implies the software was developed based on existing understanding of the ABF formula and then validated with the 29 data points as the "test set" against the established external calculation method. It's unlikely that machine learning or a training set in the modern sense was used for this type of device in 1999.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned, this question is not applicable. The device's internal ABF calculation functionality was evaluated against a pre-existing, legally marketed method of calculating ABF.
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(230 days)
IN-LINE DIAGNOSTICS CORP.
The intended use of the CRIT-SCAN II Monitor is as a continuous, non-invasive hematocrit-measuring device whereby a physician could use the information to determine the anemic state of the patient.
The intended use of the CRIT-SCAN II Monitor is as a hematocrit-measuring device.
The CRIT-SCAN II consists of state-of-the-art optoelectronics which, when combined with custom software, has the ability to measure hematocrit transcutaneously (i.e. through a patient's middle finger or index finger). The patient's finger is placed into a custom designed cuff which, when filled with air, creates the necessary perfusion for the optoelectronics to take a hematocrit reading.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy | 1.5 HCT% compared to Coulter Counter method |
| Correlation Coefficient | 0.972 (comparing CRIT-SCAN II to cell counter data) |
| Standard Deviation | 1.44 (comparing CRIT-SCAN II to cell counter data) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 198 patients
- Data Provenance:
- Country of Origin: United States (8 studies) and Sweden (1 study).
- Retrospective or Prospective: The study design indicates a prospective data collection. Data was "gathered" between December 11th, 1997, and September 10th, 1998, with measurements taken non-invasively and blood samples drawn concurrently for comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The ground truth (reference method) was stated as the Coulter Counter method, which is a laboratory instrument, not a human expert.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The comparison was directly between the CRIT-SCAN II readings and the Coulter Counter readings, which serves as the established gold standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated monitor, and the study focused on its accuracy against a laboratory reference, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone performance study was done. The CRIT-SCAN II is described as an automated device that provides a reading in less than 30 seconds. The comparison was solely between the device's output and the Coulter Counter's output, without human interpretation of the CRIT-SCAN II's raw data for diagnosis.
7. Type of Ground Truth Used
The ground truth used was a laboratory reference standard: the Coulter Counter method of hematocrit measurement. This is stated as a "highly accepted method of hematocrit measurement in the blood processing industry."
8. Sample Size for the Training Set
The document does not explicitly state the sample size for a separate training set. The descriptions of data collection appear to refer to the validation or test set. It mentions "IDC gathered data on 198 patients" for the purpose of the study detailed. It is possible that some internal data was used for development prior to this "final" study, but it's not specified here.
9. How the Ground Truth for the Training Set Was Established
Since a distinct training set is not explicitly mentioned, the method for establishing ground truth for development or training would likely be the same as for the test set: comparison to the Coulter Counter method. However, this is an inference as the document focuses on the performance against the predicate.
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(88 days)
IN-LINE DIAGNOSTICS CORP.
The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
CRIT-LINE MONITOR III (CLM III) with Access Blood Flow (ABF) Feature
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation coefficient value near 1 (i.e., .90 or greater) between CLM III ABF values and Transonic HD01 ABF values | "The results from the two tests indicate that the above described criteria were met." (Implies a correlation coefficient of .90 or greater was achieved) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 44 patients
- 30 patients from the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah.
- 14 patients from Victoria Hospital South in London, Ontario, Canada.
- Data Provenance: Prospective (described as "during normal dialysis sessions" and "during the study, a formal protocol was followed").
- Country of Origin: USA (Utah) and Canada (Ontario).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth was not established by human experts in this study. Instead, a predicate device, the Transonic HD01 Monitor, was used as the reference standard for Access Blood Flow (ABF) measurements.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was based on a predicate device's measurements, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, this was not an MRMC comparative effectiveness study. The study focused on demonstrating substantial equivalence of a new feature (ABF calculation) of an existing device to a legally marketed predicate device. There is no mention of human readers or AI assistance effect sizes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The CLM III, with its built-in capacity to measure hematocrit, was used to calculate ABF values independently. These calculated values were then compared to the ABF values obtained from the predicate Transonic HD01 Monitor. The CLM III itself did not involve human intervention in the ABF calculation process, but rather provided the raw data (hematocrit) from which ABF was calculated using external means (calculator or spreadsheet).
7. The Type of Ground Truth Used
The ground truth used was measurement from a legally marketed predicate device, specifically the Transonic HD01 Monitor.
8. The Sample Size for the Training Set
The document does not mention a separate training set. The study describes the comparison of the CLM III's ABF values to the Transonic HD01 Monitor's values. The ABF calculation method for the CLM III (from real-time hematocrit measurements) already existed, and the purpose of the submission was to claim ABF as an additional feature without hardware or software changes to the current device. Therefore, it appears the "training" was implicitly done during the initial development of the CLM III's hematocrit measurement capabilities, not specifically for the ABF feature using the data from this submission.
9. How the Ground Truth for the Training Set was Established
As no specific training set for the ABF feature is described, the ground truth establishment for a training set is not detailed. The CLM III's core functionality (hematocrit measurement) would have been established through prior validation. The ABF calculation itself appears to be a mathematical derivation from these pre-established hematocrit measurements, rather than requiring a dedicated training set with new ground truth data for the ABF parameter itself.
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(163 days)
IN-LINE DIAGNOSTICS CORP.
The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
The CLMIII consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the blood passes through the Blood Chamber.
The provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for medical device performance studies (e.g., sensitivity, specificity, accuracy against a gold standard).
Instead, the document is a 510(k) summary for the CRIT-LINE Monitor III (CLMIII), which seeks substantial equivalence to a predicate device, the CRIT-LINE II (CLMII). The basis for this equivalence is primarily technological similarity and comparison testing under simulated clinical conditions rather than a formal clinical study with defined acceptance criteria for diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (CLMIII) | Notes |
|---|---|---|---|
| Hematocrit (HCT) | Not specified | "Operate under the principles of light absorption through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT)" | The document states equivalence in function to the predicate CLMII, which already performs this measurement. No specific numerical performance metrics (e.g., accuracy, precision) for HCT are provided for the CLMIII or the CLMII. |
| Oxygen Saturation (O2 SAT) | Not specified | "Operate under the principles of light absorption through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT)" | Similar to HCT, no specific numerical performance metrics are provided. |
| Percent Change in Blood Volume (BV) | Not specified | "Calculate the related value of Blood Volume (BV)" | Derived from HCT and O2 SAT measurements. No specific numerical performance metrics are provided. |
| Substantial Equivalence | To CRIT-LINE II (CLMII) in "significant features, materials, dimensions and intended use." | The CLMIII is deemed "safe and effective and performs as well as the legally marketed CLMII." | This is the primary "acceptance criterion" for 510(k) clearance, and the conclusion is that it meets this. However, this is about equivalence to an existing device, not necessarily meeting a predefined clinical performance threshold. |
| Safety Compliance | IEC 601-1: 1988 standard. | Tests performed and concluded that the CLMIII is safe. | This is related to device safety, not clinical performance. |
| EMC/ESD Compliance | FDA Guidance for Premarket Notification Submission Appendix A Sections (ii)(a) and (ii)(b) for Electrostatic Discharge and Electromagnetic Interference (EMI). | Tests performed and concluded that the CLMIII is effective from an EMC/ESD standpoint. | This is related to device safety and functionality, not clinical performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size: Not explicitly stated. The document mentions "comparison testing to the predicate was performed on blood bank blood." It does not specify the number of blood samples or the volume of blood used.
- Data Provenance: "Blood bank blood" used for testing. The location was "at In-Line Diagnostics, Inc." This suggests in vitro or ex vivo testing under simulated clinical conditions, not data from human patients. The testing was retrospective in the sense that existing blood bank samples were used, but not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable / Not stated. The testing described is a comparison to a predicate device using blood bank blood under simulated conditions. There is no mention of "ground truth" establishment by human experts for diagnostic purposes (e.g., categorizing disease states). Instead, the "ground truth" implicitly would be the measurements obtained from the predicate device and/or standard laboratory methods for hematocrit and oxygen saturation, if such methods were used for comparison (though not specified).
4. Adjudication Method for the Test Set
- Not applicable / Not stated. No adjudication method is described because the testing did not involve human interpretation or subjective assessments that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not done. The device (CRIT-LINE Monitor III) is an automated monitoring device; it does not involve human readers interpreting images or data where AI assistance would be a factor. The comparison was to a predicate device's measurements, not to human performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The CRIT-LINE Monitor III is an automated device that provides real-time measurements. The testing described was a comparison of this automated device's output to that of the predicate automated device (CLMII) using blood bank blood. There is no human "in the loop" for the measurement itself, only for interpreting the output data and making clinical decisions (by a dialysis technician).
7. The Type of Ground Truth Used
- The "ground truth" for the comparison testing was likely measurements from the predicate device (CRIT-LINE II) and/or established laboratory methods for hematocrit and oxygen saturation. The document explicitly states "Comparison testing to the predicate was performed on blood bank blood." It does not specify if external laboratory gold standards were simultaneously used to verify either device's accuracy beyond the comparison to the predicate.
8. The Sample Size for the Training Set
- Not applicable / Not stated. The CRIT-LINE Monitor III seems to be based on physical principles of light absorption rather than a machine learning model that requires a "training set." Therefore, a training set in the AI/ML sense is not relevant here. The device hardware and software are "state-of-the-art microprocessor[s]" designed to implement existing algorithms for light absorption measurement and calculation.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As noted above, there is no mention or indication of a "training set" for a machine learning model.
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(391 days)
IN-LINE DIAGNOSTICS CORP.
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