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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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