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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 non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types.

Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.

This document describes a 510(k) premarket notification for "Disposable Medical Face Masks" (K202719) by Jiangxi Sanxin Medtec Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Disposable Medical Face Masks are based on Level 2 requirements of the ASTM F2100:2019 standard. The study demonstrates that the proposed device meets these requirements.

Table of Acceptance Criteria and Reported Device Performance:

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The proposed device, I.V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

The proposed devices, I.V. Catheters, are sterile, single use devices intended to be inserted in to a patient's vascular system for short term use to withdraw blood samples or administer fluid intravenously.

The I.V. Catheter is a closed system, and further available in two combinations of configurations. All of them are sterilized by Ethylene Oxide to achieve a SAL of 106, and packed in a sterility maintenance package. The shelf life of the product is three years.

This document is a 510(k) summary for an I.V. Catheter (K142797) submitted by Jiangxi Sanxin Medtec Co., Ltd. It declares substantial equivalence (SE) to a predicate device (K083429).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized international and ASTM standards. The reported device performance is that it complies with these standards.

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

The document does not specify the sample size used for each non-clinical test. The data provenance is indicated as "Non clinical tests were conducted to verify that the proposed device met all design specifications" (Page 5), suggesting these were performed by the manufacturer, Jiangxi Sanxin Medtec Co., Ltd. The country of origin for the device itself is China, and the tests were likely conducted there or by affiliated entities. The tests are prospective with respect to the submission, performed specifically to demonstrate compliance.

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

This document describes a 510(k) submission for a medical device (I.V. Catheter). The "tests" here are primarily engineering and biocompatibility evaluations against recognized standards, not diagnostic performance assessments requiring expert ground truth establishment in a clinical sense. Therefore, this information is not applicable and not provided in the document. The standards themselves represent expert consensus on performance requirements.

4. Adjudication method for the test set

Similarly to point 3, adjudication methods like 2+1 or 3+1 are typically for diagnostic studies where there's variability in interpretation or a need to resolve discrepancies. For the non-clinical tests listed (e.g., seal strength, sterilization, biocompatibility), the results are generally objective measurements against predefined criteria in the standards. Therefore, an adjudication method is not applicable and not provided.

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 document is for an I.V. Catheter, which is a physical medical device, not an AI software or a diagnostic imaging system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable and not mentioned.

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

As this is a physical medical device and not an algorithm, a standalone performance study in the context of an algorithm is not applicable and not discussed in the document. The non-clinical tests represent the standalone performance of the physical device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specifications and limits set forth in the referenced ASTM and ISO international standards. For example, for sterility, the ground truth is "achieve a SAL of 10^-6". For biocompatibility, it's "conforms to the requirement of ISO 10993 series Standards." This is based on established scientific and engineering principles for medical device safety and performance.

8. The sample size for the training set

This document describes non-clinical testing of a physical medical device, not a machine learning algorithm. Therefore, the concept of a "training set" is not applicable and no information is provided.

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

As there is no training set for a machine learning algorithm, this question is not applicable.

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