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The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System ™

The Moda-flx Hemodialysis System™ Cartridge is a single use blood tubing set that provides extracorporeal access during hemodialysis and is only compatible with Moda-flx Hemodialysis System™

The provided text is a 510(k) Summary for the Moda-flx Hemodialysis System™ Cartridge. It describes the device, its intended use, and comparability to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, sample sizes, information about expert-established ground truth, adjudication methods, or MRMC study details. The document states that "No animal or clinical studies were required to support this submission," which implies that a standalone performance study as typically understood for AI/ML devices involving human-in-the-loop or standalone algorithm performance was not conducted.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.

Here's a summary of what is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests that were conducted but does not provide specific acceptance criteria or quantitative performance results in a table format. It only states that the tests supported the substantial equivalence determination.

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

Not explicitly stated. The tests performed are engineering/performance verification tests of the device's physical components and functionality, not clinical test sets with patient data.

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

Not applicable, as this is not a diagnostic device relying on expert-established ground truth from clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is not a diagnostic device relying on expert adjudication of clinical data.

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:

No, an MRMC study was not done. The document explicitly states: "No animal or clinical studies were required to support this submission." This type of study is relevant for diagnostic devices, particularly those incorporating AI, which this device is not.

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

No, a standalone performance study for an algorithm was not done. This device is a physical hemodialysis cartridge, not an AI/ML algorithm.

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

Not applicable in the context of clinical ground truth. The "ground truth" for the performance tests would be established by engineering specifications and industry standards for medical device functionality and safety.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model.

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The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.

The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.

The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set. The CombiSet Bloodline is part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access.

This document describes the premarket notification (510(k)) for the CombiSet Hemodialysis Blood Tubing Set. It does NOT describe a study involving an AI device or algorithm. Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness with AI.

The document focuses on the substantial equivalence of the CombiSet Hemodialysis Blood Tubing Set to a predicate device (CombiSet SMARTECH Hemodialysis Blood Tubing Sets, K201207) through various performance, sterilization, and biocompatibility tests.

Here's the relevant information about the non-AI device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "All testing met predetermined acceptance criteria."

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

The document does not provide specific sample sizes (e.g., number of units tested) for each performance or biocompatibility test. It mentions that "samples" were tested.

• Data Provenance: The studies were conducted by Fresenius Medical Care Renal Therapies Group, LLC, likely internally or through contracted labs, as part of their 510(k) submission to the FDA. The country of origin for the data is not specified beyond being part of a US FDA submission. It is implicitly prospective testing of the manufactured device.

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

This information is not applicable as the document describes performance testing of a physical medical device (blood tubing set), not an AI device requiring expert ground truth for classification or diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the document describes performance testing of a physical medical device. The results of the physical tests (e.g., pressure resistance, leak tests) are objective measurements.

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 document is for a physical medical device (blood tubing set), not an AI device. No human reader studies or AI assistance were involved.

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

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

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

The "ground truth" for the device's performance is based on established engineering standards and regulatory requirements (e.g., ISO 8638:2010, ISO 80369-7:2016, AAMI/ANSI/ISO 10993-7:2008, ANSI/AAMI/ST72:2019, ISO 10993-1:2018, ASTM F1671-13). The device's ability to resist pressure, prevent leaks, sustain flow rates, and demonstrate biocompatibility according to these standards serves as the ground truth.

8. The sample size for the training set:

Not applicable. This document describes the testing of a physical medical device, not an AI device that requires a training set.

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

Not applicable. See point 8.

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The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.

The Tablo Cartridge is a single use blood tubing set attached to an organizer tray. The E-beam sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment.

The provided document is a 510(k) summary for the Tablo Cartridge, a medical device used in hemodialysis. It outlines the performance data submitted to the FDA to demonstrate substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/machine learning device, nor does it detail acceptance criteria and a study proving an AI device's performance in the way implied by the prompt's structured questions.

Specifically, the device in question is a physical "blood tubing set" for hemodialysis, and the changes discussed are related to manufacturing processes (sterilization method) and minor design improvements. The "performance data" refers to validation tests for sterilization, shelf-life, biocompatibility, and bench performance of the physical cartridge, not the performance metrics of an AI algorithm.

Therefore, many of the questions asked in the prompt, such as "Number of experts used to establish the ground truth for the test set," "Adjudication method," "MRMC comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "How the ground truth for the training set was established," are not applicable to the information provided in this 510(k) summary.

Based on the provided document, here's what can be extracted, acknowledging that it does not fit the typical AI/ML device study format requested:

Device: Tablo® Cartridge (Hemodialysis blood tubing set)
Nature of Submission: 510(k) for a modified device (change in sterilization method from Ethylene Oxide (EO) gas to E-beam radiation, and minor design changes).

Given the nature of the device and the modification, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to the safety and performance of the physical medical device and its manufacturing process, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table with explicit "acceptance criteria" alongside "reported device performance" values in a quantitative, pass/fail format in terms of algorithm accuracy (e.g., sensitivity, specificity, AUC). Instead, it lists various types of tests conducted to ensure the device's safety and functionality after the modification. The acceptance criteria for these tests are implied to be compliance with relevant ISO standards, USP standards, and FDA guidance documents.

Overall Conclusion: "The Tablo Cartridge (Modified Device) is substantially equivalent to the Predicate Device, and the minor difference between the Modified and the Predicate Device do not raise any new or different questions of safety or effectiveness."

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

• Sample Size: Not explicitly stated numerically (e.g., number of cartridges tested). For sterilization validation, often a statistically significant sample size based on standards like ISO 11137 is used, but the exact number isn't provided here. The same applies to shelf-life and bench performance testing.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. This is typical for device performance testing performed by the manufacturer, rather than clinical trial data.

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

• Not Applicable. This is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for this device would be objective measurements and laboratory test results demonstrating physical, chemical, and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

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:

• No. This is a physical medical device, not an AI/ML algorithm that assists human readers.

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

• Not Applicable. This is a physical medical device.

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

• For this device, the "ground truth" is established through objective laboratory testing, established chemical/biological assays, and physical performance measurements against predefined specifications and internationally recognized standards (e.g., ISO, USP). It's based on empirical measurements of device properties rather than human diagnostic interpretation.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML model.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI/ML.

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The SANSIN Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

The propose device, SANSIN Tubing Sets for Hemodialysis, is used to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The proposed devices are provided sterile and single use.

The proposed device is intended to be used with Fresenius 2008K Home Hemodialysis manufactured by Fresenius Medical Care North America, which is a hemodialysis delivery system being submitted to FDA for premarket notification (K124035).

The proposed device mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessories such as priming piece, drain bag, priming needle, fluid replacement tube, connecting tube, monitor and transducer protector.

The proposed devices are available in various specifications. Based on the different volume of air capture chamber, there are five models HDJ, HDK, HDL, HDM and HDN.

This document describes the non-clinical performance evaluation of the SANSIN Tubing Sets for Hemodialysis for its 510(k) submission (K202796).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by a combination of internal test methods, recognized consensus standards, and specific performance attributes compared against the predicate device. The document explicitly states that the non-clinical tests were conducted to verify that the proposed device met "all design specifications" and was "Substantially Equivalent (SE) to the predicate device."

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

The document does not explicitly state the specific sample sizes used for each non-clinical performance test. It mentions that tests were performed on "proposed device" or "relevant device configurations," implying that samples of the SANSIN Tubing Sets were used.

Data provenance: Given that the manufacturer is Jiangxi Sanxin Medtec Co., Ltd. in Nanchang, Jiangxi, China, and the listed contact person is in Shanghai, China, the data provenance is China. All tests appear to be retrospective (performed on completed devices or materials) and conducted by the manufacturer or a third-party testing facility.

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

This section is not applicable as the studies described are non-clinical (bench testing) rather than clinical studies involving expert interpretation of patient data. The "ground truth" for these tests is based on objective, quantifiable measurements against established standards and design specifications.

4. Adjudication Method for the Test Set

This section is not applicable as no adjudication method is mentioned or required for non-clinical bench testing. The results are based on objective test measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The SANSIN Tubing Sets are physical medical devices used for delivering hemodialysis, and their performance is evaluated through non-clinical bench tests and compatibility assessments, not human reading studies.

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

This question is not applicable as the device is not an algorithm or AI system. It is a physical medical device. The "standalone" performance here refers to the device's ability to meet its specifications independently, which is what the non-clinical tests demonstrate.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is predominantly:

• Established consensus standards: Such as various parts of ISO 10993, ISO 11135, ASTM F88, ASTM F1929, USP, ISO 594-2, and ISO 8638.
• Internal design specifications: For tests like Repeated Closing, Tensile Strength, Endurance Pump, Pressure Leak, Priming Volume, Tubing Compliance, Mechanical Hemolysis, and Stimulated Operation where specific quantitative thresholds would be defined internally by the manufacturer to ensure functional performance and equivalence to the predicate.
• Predicate device characteristics: For comparison of physical performance parameters (e.g., length, priming volume, negative pressure, inner diameter), although the proposed device did not always match the predicate, the testing demonstrated that the proposed device's different characteristics did not raise new safety or effectiveness concerns.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

The proposed devices, NovaLine Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessory which is recirculating connector. There are two models BL 11 and BL 12, The main difference between BL 11 and BL 12 is the Drip chamber on the arterial line. There is drip chamber on the arterial line of BL 12, there is no drip chamber on the arterial line of BL 11. The BL 12 has more drip chambers than the BL 11 on the whole tubing. The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

This document does not describe an AI/ML device or its performance criteria. Instead, it is a 510(k) summary for a NovaLine Tubing Sets for Hemodialysis, a medical device used in hemodialysis treatments.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device as none are present in the provided text.

The document discusses substantial equivalence for a medical tubing set based on:

• Non-clinical tests: Verification against design specifications and compliance with standards such as ISO 8638, ISO 594-2, ASTM D4169-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Biocompatibility: Conformance to ISO 10993 series standards, with the patient contact materials of the proposed device being covered by those of the predicate device.
• Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6.
• Physical performance: Comparison of tube lengths, priming volume, positive/negative pressure, and blood flow rate limitations against the predicate device, noting that both comply with relevant ISO standards.

No clinical study was included in this submission.

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The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.

The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).

The document provided is a 510(k) summary for the Dimesol Tubing Sets for Hemodialysis. It establishes substantial equivalence to predicate devices rather than proving the device meets explicit acceptance criteria through a standalone study. Therefore, some information typically found in a study demonstrating such criteria (like sample sizes for test/training sets, expert qualifications, or adjudication methods) is not applicable or not provided in the context of this 510(k) submission.

Here is a summary based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit quantitative acceptance criteria with reported numerical performance values in a distinct table, the document refers to compliance with established international standards for various performance characteristics and biocompatibility. The "acceptance criteria" are implied by adherence to these standards and by demonstrating equivalence to predicate devices.

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

The document does not specify the sample sizes used for the tests conducted to demonstrate compliance with ISO standards. It states that tests were performed but does not detail the number of units tested.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. The manufacturing entity is Bain Medical Equipment (Guangzhou) Co., Ltd. in Guangzhou, China. The testing was conducted to international standards (ISO), which are globally recognized.

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

This information is not applicable to a 510(k) submission for a hemodialysis tubing set, as it is a medical device and not an AI/software device that typically requires expert consensus for ground truth establishment. The "ground truth" for demonstrating the safety and effectiveness of this device comes from compliance with recognized performance and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device submission. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, often seen in diagnostic imaging or AI performance evaluations.

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. The Dimesol Tubing Sets for Hemodialysis are physical medical devices, not an AI or software product. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant for this submission.

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

Not applicable, as this is a physical medical device and not an algorithm or AI product.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by compliance with recognized international standards (ISO 10993 for biocompatibility, ISO 8638 and ISO 594-2 for performance) and by demonstrating substantial equivalence to legally marketed predicate devices that have already met these standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no "training set" for this physical medical device.

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The DORA Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

The proposed devices, DORA Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as two accessories which are recirculate connector and drainage bag. They are available in five (5) models, following very similar design principles, and has some differences in dimensions and configurations. The proposed devices are provided in sterile condition, it is subject to e-beam sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

This document is a 510(k) premarket notification for DORA Tubing Sets for Hemodialysis. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, it does not contain the detailed information about acceptance criteria and study design for performance metrics that would typically be found in a clinical study report or a more comprehensive performance evaluation for an AI-powered medical device.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for performance metrics in a table format, nor does it provide quantitative performance data like sensitivity, specificity, or accuracy. Instead, it refers to conformity with established international standards for medical devices.

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

This document describes non-clinical laboratory testing and does not involve patient data or a "test set" in the context of an AI/algorithm study. The testing was performed on the device itself. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

This document does not involve AI or an algorithm requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This document does not involve AI or an algorithm requiring ground truth 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

No such study was conducted or is mentioned in this document. The device is a physical medical device (tubing sets), not an AI-powered diagnostic or assistive tool.

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

Not applicable. The device is not an algorithm.

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

Not applicable. This is a physical medical device. The "ground truth" for its performance is adherence to established engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm that requires a training set.

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

Not applicable. This device is not an AI/machine learning algorithm.

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The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.

The Oxyless Blood Tubing Set is a hemodialysis blood tubing set designed to transport blood from a patient for acute or chronic hemodialysis treatment from the point of access to the dialyzer fixed to the hemodialysis machine and returning to the patient to complete the extracorporeal circuit. The tubing line components are preconfigured and packaged as an arterial line, a venous line and in some configurations, a priming line, for use with various dialysis machines from Fresenius, Nikkiso, B. Braun and Gambro. The components of the Oxyless Blood Tubing Set include pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines and tubing clamps. Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free. Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.

This document is a 510(k) Premarket Notification for a medical device, the Oxyless Blood Tubing Set. It details the device's comparison to a predicate device to establish substantial equivalence, rather than a study proving the device meets acceptance criteria based on performance metrics against a clinical ground truth.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of the requested AI/algorithm evaluation. The "acceptance criteria" discussed in this document refer to engineering and biocompatibility testing for a physical medical device, not performance metrics of an AI model against a diagnostic or predictive ground truth.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as the "study" in this context.

Here's a breakdown of what can be derived from the provided text, reinterpreting the request for AI-specific criteria to fit the presented information about a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here refer to engineering performance and biocompatibility standards for a physical medical device. The "reported device performance" indicates that these criteria were met, not specific quantitative results for each test.

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

• Sample Size for Test Set: Not explicitly stated as a single number. The testing included multiple specific tests (pressure, endurance, tensile, etc.) for which a sample size would have been used for each. The document states "Bench performance testing of the Oxyless Blood Tubing Set was conducted and compared to the predicate device."
• Data Provenance: Not applicable in the traditional sense of a clinical or imaging dataset. The "data" here are the results from in-vitro (bench) and material (biocompatibility) tests performed on the physical device. The testing was conducted to "the predicate device for its 501(k) submission" and "in accordance with the performance testing described in the FDA Guidance for Hemodialysis Blood Tubing Sets."

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

Not applicable. "Ground truth" in the context of diagnostic AI refers to a definitive clinical diagnosis or label. For this physical blood tubing set, the verification is against engineering specifications and biocompatibility standards, not against "ground truth" established by human experts in the diagnostic sense. The "ground truth" are the test specifications themselves, likely set by engineering and regulatory standards.

4. Adjudication method for the test set

Not applicable. This is not a study involving human adjudication of results for a diagnostic or predictive task. Test results are objective measurements against defined criteria.

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 document is for a physical medical device (blood tubing set), not an AI algorithm or a diagnostic assistive device.

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

Not applicable. This describes a physical medical device submission, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation consists of:

• Established engineering specifications and performance criteria for hemodialysis blood tubing sets (e.g., specific pressure limits, endurance cycles, tensile strengths).
• Biocompatibility standards as outlined in "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
• The performance characteristics of the legally marketed predicate device (Nipro Blood Tubing Set) with which it claims "substantial equivalence."

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for one.

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The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Tablo™ Cartridge is compatible only with the Tablo™ Hemodialysis System.

The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.

This document is a 510(k) summary for the Tablo™ Cartridge, a blood tubing set used for hemodialysis. It does not present a study proving the device meets acceptance criteria in the way one might expect for a clinically-oriented AI/software device. Instead, it describes performance testing to demonstrate substantial equivalence to a predicate device for a hardware medical device.

Therefore, many of the requested fields (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be common for AI/software devices. Instead, it lists types of performance testing and a general conclusion of compliance.

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

This information is Not Applicable to this document as it describes testing of a physical medical device (blood tubing set) rather than an AI/software device with a distinct "test set" of data. The testing mentioned would involve laboratory and engineering tests on physical devices.

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

This information is Not Applicable. Ground truth, in the context of expert review for medical images or data, is not relevant for the performance testing described for a blood tubing set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is Not Applicable. Adjudication methods are typically used for expert consensus on ambiguous cases in the context of diagnostic AI/software.

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

This information is Not Applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a physical device like a blood tubing set.

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

This information is Not Applicable. There is no algorithm discussed for standalone performance.

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

This information is Not Applicable. The "ground truth" for the performance of a blood tubing set would be established by validated engineering specifications, material standards, and functional requirements rather than medical expert consensus or pathology.

8. The sample size for the training set

This information is Not Applicable. Training sets are relevant for machine learning algorithms, which are not described in this submission for a physical medical device.

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

This information is Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors. The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.

The document provided is a 510(k) summary for a medical device called the "Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, much of the information requested about acceptance criteria and studies in the context of AI/diagnostic devices (e.g., sample size, ground truth, expert consensus, MRMC studies) is not applicable here.

However, I can extract information related to the device's performance, the type of testing conducted, and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way one might see for an AI diagnostic algorithm's sensitivity/specificity. Instead, it details bench testing conducted to demonstrate that the device is safe and effective and performs equivalently to its predicate. The "acceptance criteria" in this context are implicitly that the device passes these bench tests successfully.

The successful completion of these non-clinical (bench) tests forms the basis for the conclusion that the device performs equivalently to the predicate device and is safe and effective when used as intended.

The following questions are not applicable to this 510(k) submission, as it pertains to a physical medical device (blood tubing set) and relies on bench testing for substantial equivalence, not clinical studies or AI algorithm performance validation.

2. Sample sizes used for the test set and the data provenance: Not applicable. Bench testing, not a diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense needed for this device.
4. Adjudication method 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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device like this is its ability to meet performance specifications and safety criteria through bench testing.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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