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The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation. A Dialysis Dose Monitor (DDM) is a new optional accessory available with the DBB-06 (under application), which was not available in the predicate DBB-06 (K091978).

The provided text describes Nikkiso Co., Ltd.'s DBB-06 Hemodialysis Delivery System (model under application) and its substantial equivalence to a predicate device (DBB-06 Hemodialysis Delivery System, K091978), and specifically the Dialysis Dose Monitor (DDM) optional accessory to another predicate (Dialog+ Hemodialysis System with Adimea Option, K083460).

The study described primarily focuses on demonstrating the substantial equivalence of the DDM component, rather than establishing acceptance criteria and proving the device meets those criteria with a standalone study. The key performance metric discussed for the DDM is its accuracy in estimating Kt/V and URR.

Here's an attempt to extract and organize the information according to your request, with the caveat that detailed acceptance criteria defined by Nikkiso for this submission are not explicitly stated, but rather performance is compared to a predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• *1 Correlation Coefficient was obtained by comparing Kt/V from UV absorption and measurement from blood. For Adimea, two correlation coefficients were obtained for Study 1 and 2.
• *2 Measurement error in Kt/V values obtained from UV absorption relative to measurement by using blood.

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

The document refers to "Section 22 Performance Testing-Clinical for details" regarding how the correlation coefficients and errors were obtained for both the predicate Adimea and the DDM. However, Section 22 is not provided in the given text. Therefore, the specific sample size and data provenance (e.g., country of origin, retrospective/prospective) for the DDM's performance evaluation cannot be determined from the provided text.

For the predicate Adimea (K083460), two correlation coefficients (0.93, 0.80) are mentioned, implying at least two studies ("Study 1 and 2"), but specific sample sizes and provenance are not detailed here.

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

The ground truth for the DDM performance evaluation (Kt/V and URR) is stated to be derived from "measurement from blood" (e.g., blood urea nitrogen to calculate Kt/V and URR directly from blood samples), not from expert consensus on images or similar modalities. Therefore, experts for ground truth interpretation are not applicable in this context, as the ground truth is a direct physiological measurement.

4. Adjudication method for the test set

Not applicable. The performance evaluation is based on a comparison of a device's physiological estimation against direct physiological measurements, not on subjective interpretations requiring 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

Not applicable. This device is a hemodialysis delivery system with an optional Dialysis Dose Monitor, not an AI-assisted diagnostic or imaging interpretation tool that involves human readers.

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

Yes, the performance of the DDM relates to its standalone capability to estimate Kt/V and URR by optical measurement of spent dialysate fluid. The reported correlation coefficient and relative error describe the algorithm's performance in this standalone capacity, comparing its output to a more direct measurement derived from blood.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the DDM's performance evaluation is "measurement from blood" for Kt/V values. This implies biochemical analyses of blood samples to directly determine Kt/V and URR, which serves as the reference standard.

8. The sample size for the training set

The document does not provide information about a training set for the DDM. The described evaluation appears to be a performance assessment against an existing method, implying that the DDM's algorithm for calculating Kt/V and URR was likely developed and validated prior to this submission using unspecified data.

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

Not applicable, as no information on a specific training set or its ground truth establishment is provided in the document.

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The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation. A Blood Volume Monitor (BVM) is an optional accessory available for the DBB-06 HEMODIALYSIS DELIVERY SYSTEM, and was not available with the predicate device, the DBB-05 Hemodialysis Delivery System. The BVM monitors blood volume to assist in the prevention of excessive removal of fluid.

The Acceptance Criteria and the study proving the device meets these criteria for the NIKKISO DBB-06 HEMODIALYSIS DELIVERY SYSTEM, specifically focusing on its new optional accessories, the Blood Volume Monitor (BVM) and the Non-Invasive Blood Pressure (NIBP) measurement module, are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Blood Volume Monitor (BVM):

  • Test Set Sample Size: Not explicitly stated as a number of subjects. The document mentions "Clinical Test was performed." for the DBB-06 BVM. For the predicate CRIT-LINE Monitor III (K972470), "Comparison testing was performed on blood bank blood under simulated conditions" without specifying a sample size.
  • Data Provenance: Not specified for the DBB-06 BVM clinical test (e.g., country, specific demographics). For the predicate, "blood bank blood" suggests in-vitro testing. Whether the BVM clinical test was prospective or retrospective is not explicitly stated.

• Non-Invasive Blood Pressure (NIBP) measurement module (M2500):

  • Test Set Sample Size: Not specified. The comparison relies on compliance with international standards (IEC, EN, ANSI/AAMI) and documented specifications that match the predicate devices. Performance tests of these blood pressure monitors were conducted, but the sample size for these tests is not provided in the summary.
  • Data Provenance: Not specified. The manufacturer for both the M2100 and M2500 is "Omron Colin Co., Ltd., 1-12-14 Koishikawa, Bunkyo-ku, Tokyo Japan," suggesting Japanese origin for the device's development and potentially testing data. The nature of these "performance tests" (e.g., clinical, bench, simulated) and their provenance is not detailed.

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

• Blood Volume Monitor (BVM): Not applicable. Ground truth for BVM accuracy is stated as "compare well with other methods such as centrifuge." This implies a gold standard measurement method rather than expert consensus on interpretation.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Not applicable. The ground truth for blood pressure measurement accuracy is typically established against validated reference devices (e.g., intra-arterial measurements) or through compliance with recognized standards (e.g., ANSI/AAMI SP-10). Expert interpretation of NIBP readings against a gold standard is generally not how NIBP accuracy is assessed in regulatory submissions.

4. Adjudication Method for the Test Set

Not applicable for either the BVM or NIBP module, as the assessments are based on objective measurements and compliance with technical specifications and standards rather than subjective expert review requiring adjudication.

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

Not applicable. The devices are objective measurement tools, not systems that rely on human interpretation of complex data (like diagnostic imaging). Therefore, an MRMC study to measure improvement in human reader performance with AI assistance is not relevant to this type of device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Blood Volume Monitor (BVM): Yes. The BVM's performance, including its accuracy of approximately +/-2%, operates independently to calculate blood volume based on light absorption. The "Clinical Test was performed" for the BVM would assess this standalone performance.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Yes. The M2500 NIBP module's performance, including its measuring range and accuracy (0 to 300mmHg, within +/-3mmHg), is an inherent function of the device itself. Performance tests (referenced but not detailed) would evaluate its standalone accuracy against an appropriate reference.

7. Type of Ground Truth Used

• Blood Volume Monitor (BVM): "Comparison well with other methods such as centrifuge." This refers to established laboratory methods for measuring hematocrit, which is then used to calculate blood volume.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Compliance with international standards (IEC60601-2-30, EN1060-1, EN1060-3, ANSI/AAMI SP-10) which define accuracy requirements, often referencing invasive blood pressure measurements or other validated non-invasive methods as the "ground truth."

8. Sample Size for the Training Set

No training set information is provided as the devices described (BVM and NIBP module) are based on established physical principles and algorithms, not machine learning models that require training data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is described for these devices.

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