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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.

Regarding AI/Algorithm-Specific Questions (2-7):

The provided text does not contain any information related to an AI/algorithm for diagnostic or prognostic purposes, and therefore, these questions cannot be answered from the given document. The software mentioned "controls the machine during hemodialysis treatment" rather than performing analytical or interpretive tasks characteristic of AI in medical imaging or diagnostics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This is a physical device, not a diagnostic AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

Regarding Training Set Information (8-9):

The document mentions "Software Verification and Validation Testing" but does not describe a "training set" in the context of machine learning or AI. The software is for controlling the hemodialysis machine's functions.

8. The sample size for the training set: Not applicable. The software performs control functions for the machine, not an AI model that requires a training set of data.
9. How the ground truth for the training set was established: Not applicable for the same reasons as above. The software is validated against functional requirements and design specifications, not against a "ground truth" for a learned AI task.

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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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