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510(k) Data Aggregation
(191 days)
CRIT-LINE MONITOR III (CLM III)
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(28 days)
CRIT-LINE MONITOR III (CLM III)
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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(88 days)
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
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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