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The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.

The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

The devices are packaged sterile and labeled for single use only.

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.

Here's a breakdown of the acceptance criteria and study information for the NovaLine SP-C35 Transducer Protector based on the provided FDA 510(k) summary.

Note: This document describes a medical device, not an AI or software-based medical device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Device: NovaLine SP-C35 Transducer Protector

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

The document does not specify exact sample sizes for each test within the finished product performance, packaging, or shelf-life evaluations. It mentions "proposed devices" were tested, implying a statistical sample was used according to the relevant standards, but the specific number is not provided.

Data Provenance: The tests were conducted by Bain Medical Equipment (Guangzhou) Co., Ltd. in China. The data is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

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

Not Applicable. This is a medical device (transducer protector) and not an AI/software device. The "ground truth" here refers to the physical and biological properties of the device, established through standardized laboratory testing, not human expert interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/software device involving human interpretation, there is no adjudication method in the traditional sense. Device performance is determined by objective, measurable laboratory tests against pre-defined specifications and standards.

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

No. An MRMC study is relevant for imaging or diagnostic AI, comparing human readers with and without AI assistance. This device is a component of a hemodialysis system, and its performance is assessed through physical, chemical, and biological testing.

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

Not Applicable. This device is hardware, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Standardized Test Results: Objective measurements from various laboratory tests (e.g., dimensional measurements, sterile barrier integrity, biocompatibility assays).
• Compliance with Recognized Standards: Adherence to international and national standards such as ISO 80369-7, ISO 10993 series, ASTM F88, ASTM F1929, ASTM D4169, USP , ASTM F1671, etc.
• Predicate Device Equivalence: Direct comparison to the performance characteristics of a legally marketed predicate device (Nipro Transducer Protector TP-SURE, K072988) where applicable.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not Applicable. See response to #8.

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The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

The Nipro Transducer Protector TP-SURE consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.1 um. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.

The TP-SURE is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.1 µm hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.

The provided text is a 510(k) Summary for the NIPRO Transducer Protector TP-SURE. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or an analytical study that rigorously proves the device meets such criteria as would typically be described in a research paper or a detailed performance validation report.

The document states that "Performance testing was conducted to verify that the device is safe and effective for its intended use" and that "The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO Transducer Protector TP-SURE performs equivalent to the predicate device and is safe and effective when used as intended." This general statement indicates that tests were performed, but it lacks the specifics requested in your prompt.

Therefore, for almost all of your requested information, the answer is "Not provided in the document."

Here's a breakdown of what can be extracted or inferred, and what is not provided:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in a tabular format. The general criteria are implied to be "safe and effective for its intended use" and "performs equivalent to the predicate device."
• Reported Device Performance: No specific quantitative performance metrics (e.g., filtration efficiency, pressure drop, burst strength) with their respective values are provided.

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

• Sample Size for Test Set: Not provided.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not provided.

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

• Number of Experts: Not applicable, as this device does not involve expert interpretation or diagnosis for "ground truth." The performance testing would be against engineering specifications for physical characteristics and filtration efficacy.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable, as this device does not involve expert interpretation or diagnosis.

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

• MRMC Study: No. This is a medical device (a transducer protector) that does not involve AI assistance or human interpretation in its function.

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

• Standalone Performance: Not applicable in the context of an "algorithm." The device's performance is inherently "standalone" in its mechanical and filtration function.

7. The type of ground truth used

• Type of Ground Truth: For a physical device like this, "ground truth" would typically be established through engineering specifications, validated test methods (e.g., for filtration efficiency, material compatibility, pressure resistance), and compliance with relevant standards. The document mentions "Biocompatibility testing" and "performance testing" which would fall under this category, but specific details of the ground truth (e.g., exact pore size verification, bacterial challenge results) are not provided.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a manufactured physical good, not an AI/ML model that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

In summary, the provided document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device and general statements about performance and biocompatibility testing, rather than detailed analytical study results proving specific acceptance criteria.

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Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine's pressure transducer.

Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 um hydrophobic filter helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, viruses, bacteria, and particulate matter into the pressure monitor at pressures lower than the rated pressure of the device.

The provided text describes a 510(k) submission for "Medisystems Transducer Protectors" and focuses on establishing substantial equivalence to previously marketed devices. It details the device's intended use and technological characteristics. However, it does not contain the specific information required to complete the requested table and answer the study-related questions.

The document primarily states that the product is "tested and must meet all required release specifications before distribution," including "sterility, pyrogenicity, physical testing, and visual examination." It refers to "written and approved procedures that conform to the product design specifications" in "Device Master Records," but these specifics are not provided.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Study Information (Based on availability in the text):

• 2. Sample size used for the test set and the data provenance: Not available. The document states "To assure that the device is safe and effective, all finished products are tested," implying ongoing manufacturing testing rather than a single clinical study for market approval.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This sounds like an AI/machine learning evaluation, which is not the context of this 510(k) submission. For mechanical devices like transducers, "ground truth" typically refers to established engineering standards and test methods.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not available.
• 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 k-submission is for a physical medical device (transducer protector), not an AI-assisted diagnostic tool.
• 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): For manufacturing release, the "ground truth" would be the pre-defined engineering and sterility specifications (e.g., lack of bacterial growth for sterility, specific pressure tolerance for physical testing).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a regulatory submission for a physical medical device. It outlines the device's function and the general commitment to quality control testing, but it does not describe a clinical study or performance evaluation in the way that would typically be associated with software or AI-driven diagnostics, which is what the detailed questions seem to be geared towards. The "study" here is the ongoing manufacturing testing to meet "release specifications."

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The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.

The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.

I'm sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and study details for the "Better-Bladder™" device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It lists the device's indications for use but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance. The letter mentions "premarket notification submission" but doesn't detail the study itself.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set.
5. Information on whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Information on whether a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on regulatory clearance based on substantial equivalence, not a detailed scientific study report.

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Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.

Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.

The provided 510(k) summary describes a medical device, the Medisystems Transducer Protectors, and its asserted equivalence to a predicate device. However, it does not include the kind of detailed study information (acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies) that would typically be found in a submission for a device involving AI or complex performance claims. This summary is for a relatively simple disposable component, and thus the "study" described is primarily quality control and manufacturing process validation rather than a clinical performance study.

Here's an analysis based only on the provided text, highlighting what's not present given the nature of the request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The submission refers to "all finished products" being tested as part of the release specifications. This implies a manufacturing quality control process rather than a discrete clinical/performance study with a defined sample size for a test set.
• Data Provenance: Not applicable in the context of clinical or AI-related data. The testing described is part of the manufacturing and quality assurance process.

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

• Not applicable. The "ground truth" for this device's performance comes from its physical properties (0.2 µm filter, hydrophobic nature) and manufacturing quality control tests (sterility, pyrogenicity, physical testing, visual examination) against defined specifications, not from expert interpretation of complex data.

4. Adjudication method for the test set

• Not applicable. There is no expert adjudication process described. The acceptance criteria are objective tests against specifications.

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 device is a passive mechanical filter. It does not involve AI or human readers, so an MRMC study is not relevant or described.

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

• Not applicable. This device is a passive mechanical filter. There is no algorithm or AI component mentioned.

7. The type of ground truth used

• Objective physical and chemical properties, combined with manufacturing process control specifications. The device's function relies on its 0.2 µm pore size and hydrophobic material. "Ground truth" for its performance is established by demonstrating these properties and verifying manufacturing quality (sterility, pyrogenicity, physical integrity) according to internal procedures and specifications.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this device does not involve machine learning or AI.

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

• Not applicable. There is no training set mentioned.

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