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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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The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner.

The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS includes arterial and venous dialysis blood tubing (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during for hemodialysis procedures. Three models of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS (AV06A-P, AV06B-P, AV06C-P) are being manufactured for use with the Nikkiso DBB-05 Hemodialysis Delivery System (K061519). The components of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS include pump tubing, air trap chambers, transducer filters, pressure monitoring lines, infusion lines for saline, access ports and tubing clamps which are all used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices. Major materials used for the various components are Polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP). Materials in direct contact with blood are Polycarbonate (PC), Polyvinyl chloride (PVC), Silicone, Polypropylene (PP) and Polytetrafluoroethylene (PTFE). The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are restricted for sale by or on the orders of a physician. The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are packaged sterile and labeled for single use only and non-pyrogenic.

The provided document describes the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, a medical device intended for hemodialysis, and its substantial equivalence to a predicate device, the Nipro® Blood Tubing Set with Transducer Protectors and Priming Set (K010264). The acceptance criteria and the study proving conformance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a dataset for algorithmic evaluation. Instead, the testing described appears to be for verification and validation of the physical device according to established standards.

• Sample Size: Not explicitly stated for each specific test, but the document implies that "all tests required in RD17" were performed on both the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS and the Nipro tubing set.
• Data Provenance: The tests were performed by NIKKISO CO., LTD. for their device and were compared against the predicate device's performance which was also evaluated against the same standard by Nipro. The country of origin for NIKKISO CO., LTD. is Japan. The data is prospective in the sense that the tests were conducted specifically for the submission.

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

Not applicable. The ground truth for this device's performance is established by conformance to recognized international and national standards (ANSI/AAMI RD17: 2007 and ISO10993), rather than expert consensus on a test set.

4. Adjudication Method

Not applicable. The evaluation is based on meeting pre-defined criteria in engineering and biological safety standards, not on subjective expert assessment requiring adjudication.

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

Not applicable. This device is a physical medical accessory for hemodialysis tubing, not an AI or diagnostic imaging device that would typically undergo an MRMC study for human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth is based on established industry standards and regulatory requirements as defined in:

• ANSI/AAMI RD17: 2007 "Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofitters"
• ISO10993 (various parts for biocompatibility)
• ISO11134 and EN554 (for steam sterilization validation)
• ISO11135-1 (for Ethylene Oxide sterilization, referenced for the predicate)

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is relevant for this device.

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The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.

The DBB-05 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 dialyser 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 dialyser is controlled automatically by adjustment of the Ultra Filtration (UF) amount and UF rate by the dialyser. Heparinization of the external circulating blood is performed with the heparin pump either by continuous or one-shot injection before it is passed on to the dialyser. The DBB-05 Hemodialysis Delivery System uses both acetate dialysis and bicarbonate dialysis. Using the various functions of the device, the conductivity and UF profile can be programmed. In addition, DBB-05 Hemodialysis Delivery System incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis treatment. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with the necessary protective systems for patient safety and correct operation.

The provided text is a 510(k) summary for the DBB-05 Hemodialysis Delivery System. It describes the device, its intended use, and claims substantial equivalence to a predicate device (the original Nikkiso DBB-05 Hemodialysis Delivery System cleared under K023509).

However, the summary does not contain the detailed information required to fill out the table and answer the specific questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document explicitly states that the device received a 510(k) clearance based on "substantial equivalence" to a predicate device. This means the manufacturer argued the new device is as safe and effective as the previously cleared device, not necessarily that it met new, quantitative acceptance criteria through a specific performance study outlined in the summary.
• No Standalone Study Described: The core argument for clearance is equivalence, not a standalone performance study. While it mentions "verification and validation activities," these are described generally as proving the modified device is substantially equivalent, not as a specific clinical or technical study with defined acceptance criteria and performance results.
• No Information on Test Sets, Ground Truth, Experts, MRMC, or Training: Since a specific performance study proving new acceptance criteria is not described, all related questions about sample sizes, data provenance, number of experts, ground truth, MRMC studies, and training sets are unanswered by the provided text.

In summary, the document states that the device is substantially equivalent to a predicate device, and the modifications do not raise new safety or effectiveness questions. It does not provide data from a study designed to demonstrate performance against specific, quantifiable acceptance criteria.

Therefore, I cannot populate the table or answer the questions as requested based only on the provided text. The missing information would typically be found in a more detailed Device Description, Performance Data, or Clinical Data section of a 510(k) submission, which is not fully included here.

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