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This device 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. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Ethylene Oxide) includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.

These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

This document is a 510(k) clearance letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)" and "BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series". It focuses on proving substantial equivalence to a predicate device, rather than providing the detailed acceptance criteria and study results for a new, innovative AI/software device.

Therefore, this document does not contain the information requested regarding acceptance criteria and performance studies for an AI/software device. The questions in the prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the validation of AI/Software as a Medical Device (SaMD), which is not the subject of this 510(k) clearance.

This submission primarily addresses:

• Device Description: Physical components and intended use of blood tubing lines.
• Technological Characteristics: Comparison of materials, design, and sterilization method to a predicate device.
• Bench Testing: Mechanical and functional performance tests for the physical tubing, such as structural integrity, pump segment performance, and resistance to kinking.
• Biological Safety Testing: Biocompatibility tests for materials in contact with blood.
• Sterilization and Shelf Life: Validation of these aspects.

There is no mention of any AI or software components, nor any studies that would involve human readers, ground truth established by experts, or deep learning models, which are the focus of your prompt's questions.

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The intended indications for use of the PICO 14 is for individuals with mild to moderate pain associated with carpal tunnel syndrome. It is designed to provide support and compression to the wrist, helping to alleviate discomfort and promote healing.

A very compact and versatile smart plug with Wi-Fi connectivity, energy monitoring, and scheduling capabilities.

The provided text describes the FDA clearance for the DBB-06 PRO Hemodialysis Delivery System. However, it does not contain detailed information regarding acceptance criteria for specific device performance metrics (e.g., sensitivity, specificity, accuracy) nor does it describe specific studies that prove the device meets such criteria in the context of an AI/algorithm-driven medical device.

The document focuses on:

• Safety and Performance of a Physical Hemodialysis Machine: It outlines various engineering specifications, material compatibility, sterilization validation, electrical safety, and software verification for a hemodialysis delivery system.
• Substantial Equivalence: The primary goal of the 510(k) submission is to demonstrate that the DBB-06 PRO is substantially equivalent to predicate devices (DBB-06 Hemodialysis Delivery System and 2008T Bluestar Hemodialysis Machine).
• General Performance Testing: The "Performance – Bench Testing" section lists various types of tests conducted (e.g., "System Level Performance Testing," "Disinfection Validation Testing," "Bacterial Retention Testing"), but it does not provide acceptance criteria for these tests nor the specific performance results in a way that would allow for the population of the requested table for an AI model.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a physical medical device (hemodialysis machine) rather than an AI-driven diagnostic or prognostic algorithm. Specifically, sections 1-7 of your request are not applicable as presented because there is no AI/algorithm being evaluated for diagnostic or prognostic performance with associated metrics like sensitivity, specificity, or reader studies.

The document does mention "Software controls the machine during hemodialysis treatment" and "Software Verification and Validation Testing," indicating software components are present, but these are for controlling the machine's operation, not for diagnostic interpretation or prediction in an AI context.

Here's what can be extracted, and where limitations exist:

1. Table of Acceptance Criteria and Reported Device Performance

• Limitation: The document provides "Key Performance Characteristics" (Table 1) for various mechanical and electrical aspects of the hemodialysis machine. These are specifications (e.g., "Flow rate accuracy: Set value ±10%") rather than acceptance criteria for an AI model's diagnostic/prognostic performance (like sensitivity, specificity, AUC). No reported performance results against specific acceptance criteria for AI are available.

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This device 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. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Steam) includes arterial and venous dialysis blood tubing.

The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System.

The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.

These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

Based on the provided FDA 510(k) Clearance Letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) and C18 Series," the device in question is blood tubing lines, not an AI/software device. Therefore, many of the typical acceptance criteria and study components associated with AI-powered medical devices (like those requiring test sets, expert ground truth, MRMC studies, standalone performance, and extensive training data) are not applicable to this product.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Technological Characteristics: Same intended use, design, configuration, scientific technology, and principles of operation.
• Material Equivalence: Similar materials, with no new or additional materials posing unaddressed risks.
• Performance Testing: Bench testing, sterilization validation, shelf-life testing, and biological safety testing.
• Compatibility: Ensuring compatibility with the intended hemodialysis delivery system.

Given that this is a physical medical device (blood tubing lines) and not a software/AI device, the request for a table of acceptance criteria and study details as typically applied to AI devices cannot be fully fulfilled from the provided document. The document confirms that no clinical performance data and no animal performance data were submitted for this 510(k). This is typical for Class II devices demonstrating substantial equivalence where bench and preclinical testing are sufficient based on established predicate devices and known risks.

However, I can extract the types of performance testing and safety evaluations that were conducted to "prove the device meets acceptance criteria" for a physical medical device:

Acceptance Criteria and Study for BLOOD TUBING LINES FOR HEMODIALYSIS (K242479)

Context: This device is a physical medical device (blood tubing lines) used in hemodialysis, not an AI or software-based device. Therefore, the "acceptance criteria" and "study" described below relate to the physical and biological performance of the tubing lines themselves, demonstrating their safety and effectiveness through substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each bench, biological, sterilization, or shelf-life test. This information is typically detailed in the full submission, not the summary.
• Data Provenance: The studies are described as "completed" by the submitter, NIKKISO CO., LTD. The typical provenance for such tests would be internal lab testing or accredited third-party labs where the devices are manufactured or tested. No country of origin for the data itself is specified beyond the applicant being from Japan. These are pre-market, prospective tests performed specifically for this 510(k) submission.

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

• Not Applicable. This is a physical device clearance based on engineering performance and biological safety tests, not an AI device requiring expert-labeled medical imaging or clinical data. Ground truth for these types of tests is established through standardized methodologies (e.g., ISO standards, ASTM standards, AAMI standards) and quantitative measurements rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no "test set" in the context of expert adjudication for AI models exists for this device. Performance is determined by meeting pre-defined quantitative thresholds and qualitative observations in laboratory settings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

• No. An MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance for diagnostic tasks. This device is blood tubing lines, not an AI diagnostic tool.
• The 510(k) summary explicitly states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)."

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

• Not Applicable. This is not a software algorithm. The "standalone performance" of the blood tubing refers to its ability to perform its function (e.g., maintain structural integrity, prevent kinking, ensure blood flow pathways) independently, which is covered by the extensive bench testing listed.

7. The Type of Ground Truth Used

• For Physical Performance/Bench Testing: Ground truth is defined by objective engineering specifications, performance standards (e.g., ISO, AAMI, ASTM), and quantitative measurements (e.g., tensile strength values, flow rates, volume measurements, pressure limits). These are often derived from predicate device performance and established medical device standards.
• For Biological Safety Testing: Ground truth is established by the results of standardized biological assays conforming to ISO 10993 series and FDA guidance, where specific chemical or biological reactions (e.g., cytotoxicity, hemolysis, pyrogenicity) are measured against predefined safety limits.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of machine learning for this physical medical device. The device itself is manufactured, not "trained."

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

• Not Applicable. As there is no training set for an AI/software model, no ground truth needed to be established for it. The design and manufacturing process for the blood tubing lines are validated through the various tests described above, ensuring they meet the specified performance and safety characteristics.

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This device 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. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The provided text is a 510(k) summary for a medical device (Blood Tubing Lines for Hemodialysis AV06C-E). It details the device's characteristics, intended use, and comparison to a predicate device, focusing on demonstrating substantial equivalence based on recognized standards and bench testing.

However, the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in this document.

This document outlines various tests conducted (sterilization, biological safety, bench performance) to support the device's safety and effectiveness compared to a predicate, but it does not provide explicit acceptance criteria with numerical values or detailed study designs for those criteria as you've requested. It indicates what tests were done (e.g., Cytotoxicity, Structural Integrity, Pump Segment Performance) but not the specific thresholds for acceptance or the methodology of the associated studies in the depth you're looking for.

Therefore, I cannot populate the table or answer most of your detailed questions from the provided text.

Here's what I can extract and state explicitly from the document regarding the information you asked for:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated in the document with specific numerical criteria and outcomes against those criteria. The document states "Sterilization validation and Shelf Life test were completed using the subject device," "Biological safety testing was completed to confirm the safety of the subject device," and "Bench testing was completed to confirm the subject device is substantially equivalent to the predicate device in performance." It then lists the types of tests performed.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device's evaluation is primarily based on bench testing, sterilization, and biological safety, not expert interpretation of diagnostic images or clinical outcomes.
• Adjudication method for the test set: Not applicable.
• 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 is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
• The type of ground truth used: For biological safety, it's based on standard biological safety tests (e.g., cytotoxicity, sensitization, systemic toxicity, hemocompatibility). For bench performance, it's based on engineering and performance standards relevant to blood tubing lines (e.g., structural integrity, pump segment performance, tensile strength, flow dynamics).
• The sample size for the training set: Not applicable (not an AI/learning algorithm).
• How the ground truth for the training set was established: Not applicable.

The document emphasizes that the device is "substantially equivalent" to a predicate device, meaning it has similar intended use, design, configuration, scientific technology, and principles of operation, with only minor differences that do not raise new questions of safety and effectiveness. The demonstration of this equivalence relies on a series of validations and bench performance tests listed by appendix number.

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This device 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. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) includes arterial and venous dialysis blood tubing.

The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series is one part of a blood tubing lines device for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

I'm limited to the information provided and cannot determine the acceptance criteria or reported device performance for NIKKISO Co., Ltd.'s Blood Tubing Lines since the text does not contain such details. The document is a 510(k) summary, which outlines the device description, intended use, and technological characteristics, but does not provide specific performance data or acceptance criteria that a study would prove the device meets. The listed "Test Item" reports are general performance tests and do not include the acceptance criteria or the numerical results that would fulfill the criteria. Therefore, I cannot construct the table you requested.

The document states that no animal or clinical performance data was submitted, so a study with a test set, ground truth, or adjudication methods as requested in your prompt was not provided in this 510(k) submission.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Cannot be provided as this information is not present in the document.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no performance study results were provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study results were provided.
4. Adjudication method for the test set: Not applicable, as no performance study results were provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, no clinical performance data was submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical medical device (blood tubing lines), not an AI algorithm, so this question is not applicable. No standalone performance study results were provided.
7. The type of ground truth used: Not applicable, as no performance study results were provided.
8. The sample size for the training set: Not applicable, as no AI algorithm is involved.
9. How the ground truth for the training set was established: Not applicable, as no AI algorithm is involved.

The document lists various "Test Item" reports (e.g., Sterilization Barrier System Performance Test, Mechanical Hemolysis, Structural Integrity), but these are general performance tests for the device's functionality rather than a study designed to meet specific clinical acceptance criteria. The submission declares that the device is "substantially equivalent" to a predicate device (K082719) based on similar intended use and technological characteristics, with only minor differences that "do not raise new questions of safety and effectiveness." This indicates that the regulatory clearance relies on equivalence to a previously approved device rather than presenting new performance data against specific acceptance criteria.

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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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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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Ask a specific question about this device