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The Infusion Sets for Single Use with Needles is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The Infusion Sets for Single Use with Needles is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. It consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, spike, drip chamber, flow regulator, flexible tube, conical fitting, and injection needle/intravenous needle. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile and single use.

The provided document is a 510(k) summary for a medical device (Infusion Sets for Single Use with Needles) and does not describe a study involving an AI/Machine Learning device that utilizes a test set, expert readers, or ground truth in the way a diagnostic AI would.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device by comparing technical characteristics and performance standards. The "acceptance criteria" and "study" described here refer to non-clinical performance testing to ensure the device meets specified engineering and safety standards, rather than evaluating diagnostic accuracy of an AI model.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test set, number of experts for ground truth, MRMC studies, effect size of AI assistance, standalone performance, and training set details) are not applicable to this 510(k) submission.

Here's an interpretation of the document's content in a way that aligns with your request as much as possible, focusing on the quality and performance testing described:

Device: Infusion Sets for Single Use with Needles (K221069)

Type of Study: Non-Clinical Performance Testing and Biocompatibility Testing for Substantial Equivalence Determination. This is not an AI/ML diagnostic performance study.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like infusion sets, acceptance criteria are typically defined by recognized international and national standards. The "performance" is demonstrated by showing compliance with these standards.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of infusion sets tested for flow rate, sterility, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." Regulatory standards often dictate minimum sample sizes for such tests, but these are not enumerated in the summary.
• Data Provenance: The testing was conducted by Sichuan Prius Biotechnology Co., Ltd. (China). The data represents laboratory testing results performed on the manufactured devices. The studies are by nature prospective, as they are specifically conducted to support the 510(k) submission for the new device.

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

• This concept is not applicable. For non-clinical performance and biocompatibility testing, "ground truth" is established by adherence to validated international standards and test methods (e.g., ISO, ASTM, USP). The expertise lies in the qualifications of the testing laboratories and personnel conducting these specific, standardized tests (e.g., chemists, material scientists, engineers, microbiologists). The document does not specify how many or the qualifications of the testing personnel, as it's assumed to be part of standard quality system requirements for medical device manufacturing and testing.

4. Adjudication Method for the Test Set

• This concept is not applicable. Performance testing results are either compliant with the specified standard and acceptance criteria or they are not. There is no "adjudication" in the sense of reconciling differing expert opinions or interpretations, as would be the case in subjective diagnostic AI assessments.

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/ML device, nor is it a diagnostic imaging device that involves human reader interpretation. No MRMC study was performed.

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

• Not applicable. This is not an algorithm or AI device. The device itself (infusion set) functions independently of human interpretation concerning its core performance metrics (e.g., flow rate, sterility, tensile strength).

7. The type of ground truth used

• Ground Truth: For this type of device, "ground truth" is defined by established international and national standards, regulatory requirements, and validated test methods. Compliance with these standards (e.g., ISO for biological evaluation, physical properties; ASTM for material properties, package integrity; USP for sterility, pyrogens) indicates that the device performs as intended and is safe. The document repeatedly states, "Comply with ISO X," "meets the requirements of ISO Y," or "test result can meet the requirements."

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of medical device which undergoes compliance testing rather than AI model training.

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

• Not applicable, as there is no training set.

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Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.

Safety Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needle sticks.

The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. It has two models, Intravenous Needle for Single Use and Safety Intravenous Needle for Single Use. For the Safety Intravenous Needle for Single Use, the safety sheath is designed to prevent accidental needlesticks. The proposed devices are provided sterile, single use.

The Intravenous Needle for Single Use consists of six components, 1) infusion needle 2) needle handle 3) flexible tube 4) needle protective cover 5) conical fitting 6) conical fitting protective cap. The Safety Intravenous Needle for Single Use consists of seven components, 1) infusion needle 2) needle handle 3) flexible tube 4) needle protective cover 5) conical fitting 6) conical fitting protective cap 7) Safety Sheath.

The provided text describes a 510(k) premarket notification for Intravenous Needles for Single Use and Safety Intravenous Needles for Single Use. This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study in the way typically associated with AI/software devices.

Therefore, many of the questions regarding acceptance criteria, study design, and performance metrics for AI devices are not applicable to this submission. This document pertains to a traditional medical device (intravenous needles), where performance is generally assessed through non-clinical bench testing and adherence to recognized standards.

Here's an breakdown of the relevant information based on the provided text:

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

The document does not present a single table of "acceptance criteria" and "reported device performance" in the context of an AI/software device. Instead, the performance is demonstrated through compliance with various international and ASTM standards for medical devices. The "acceptance criteria" are implied by these standards, and the "reported device performance" is a statement of compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for testing beyond the general statement of compliance with standards. These are non-clinical engineering and biocompatibility tests. Data provenance in terms of country of origin or retrospective/prospective does not apply here as it's not a clinical study. These tests would have been conducted by the manufacturer in China or by contracted laboratories.

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)

This question is not applicable. The ground truth for device performance in this context is established by the specifications and methodologies outlined in the referenced international standards (e.g., ISO, ASTM, USP). There are no "experts" in the sense of clinical specialists establishing a ground truth for a diagnostic outcome.

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

This question is not applicable. Adjudication methods are relevant for clinical studies with subjective interpretations, which is not the case for the non-clinical tests described.

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 question is not applicable. This is not an AI-assisted device, nor is it a diagnostic device where human "readers" would be involved in interpreting results.

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

This question is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical tests is defined by the objective measurement criteria and methodologies specified in the cited international regulatory standards (e.g., ISO, ASTM, USP) for the physical and biological properties of the device.

8. The sample size for the training set

This question is 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

This question is not applicable.

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The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The proposed device consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, drip chamber, drip tube, flow regulator, flexible tube, and conical fitting. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile, single use.

The provided document is a 510(k) Summary for a medical device (Infusion Sets for Single Use) and not a study describing the acceptance criteria and performance of an AI/ML powered device. Therefore, the requested information regarding AI/ML device performance, acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, and training set details cannot be extracted from this document.

The document discusses the substantial equivalence of the proposed device to a predicate device, focusing on material, physical characteristics, and compliance with various ISO and ASTM standards relevant to infusion sets (e.g., sterilization, biocompatibility, seal strength, flow rates). It explicitly states:

• No clinical study is included in this submission. This means there is no data on human-in-the-loop performance, standalone algorithm performance, or the benefits of AI assistance.
• The device being reviewed is a physical medical device (Infusion Sets for Single Use), not an AI/ML algorithm or system.

Therefore, I cannot fulfill your request using the provided text.

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The Sterile Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration of fluids for medical purpose.

The Sterile Hypodermic Syringes for Single Use with Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle. The proposed device is available in a variety combination of syringe volume and needle size.

The provided text describes a 510(k) premarket notification for "Sterile Hypodermic Syringes for Single Use with Needles." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm evaluation.

Therefore, many of the requested sections about acceptance criteria, clinical studies, reader studies, and ground truth establishment are not applicable to this type of regulatory submission and the provided document.

Here's an analysis based on the available information:

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

The document does not present a table of acceptance criteria and reported device performance in the way a clinical study or standalone algorithm study would. Instead, it demonstrates compliance with recognized international standards for medical devices. The "reported device performance" is essentially that the device complied with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes non-clinical laboratory testing (e.g., physical performance, biocompatibility, sterilization validation) but does not detail the sample sizes for these tests or the data provenance. The tests are general in nature for medical device components and manufacturing processes, not related to patient data.

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)

This is not applicable to this submission. Ground truth established by medical experts (like radiologists) is relevant for diagnostic devices or AI algorithms that interpret medical data. This submission is for a physical medical device (syringes and needles). The "ground truth" here is compliance with engineering and material standards, which is assessed through laboratory testing by qualified personnel, not by medical experts establishing diagnostic ground truth.

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

This is not applicable to this submission. Adjudication methods are typically used in clinical trials or reader studies where multiple human readers or algorithms provide interpretations that need to be resolved to establish a definitive ground truth. The testing described here is based on objective measurements against established international standards.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or decision support systems. The device in question is a sterile hypodermic syringe with needles, which is a physical device used for aspiration and injection, not an AI or diagnostic tool.

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

A standalone performance study for an algorithm was not done. This device is not an algorithm.

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

The "ground truth" for the device's performance is established by international standards and regulations for the physical, chemical, and biological properties of sterile hypodermic syringes and needles. This includes:

• Physical performance requirements (e.g., according to ISO 7886-1, ISO 7864, ISO 9626)
• Biocompatibility (e.g., according to ISO 10993-1)
• Sterility Assurance Level (SAL) (e.g., according to ISO 11135)
• Particulate matter levels (e.g., according to USP )
• Endotoxin levels (e.g., according to USP )

These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology reports.

8. The sample size for the training set

This is not applicable. This device is a physical medical product, not an AI algorithm that requires a training set.

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

This is not applicable. As stated above, this device is not an AI algorithm and therefore does not have a "training set" or "ground truth for a training set."

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The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

The provided text describes the regulatory clearance (510(k)) for the "Sterile Hypodermic Syringes for Single Use with Safety Needles" by Sichuan Prius Biotechnology Co., Ltd. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report for AI-powered medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this given text.

However, I can extract the acceptance criteria and performance data for the non-clinical functional and safety aspects of the device, as well as general information about testing methodologies.

1. Table of acceptance criteria and the reported device performance:

The following questions are not applicable as the document describes a traditional medical device (syringes with safety needles) and not an AI/ML-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is for physical characteristics and biological safety, not a "test set" in the AI/ML context.
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. This refers to expert review for AI/ML model training/validation.
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 for an AI context. For physical device testing, "ground truth" is established by the specified ISO/ASTM standards and their associated test methods for measuring properties (e.g., strength, sterility, dimensions).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle. The proposed device is available in a variety syringe volume. Syringe volume: 1ml, 2ml, 3ml, 5ml, 20ml, 30ml, 50ml, 60ml, 100ml

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

This document is a 510(k) Summary for a medical device called "Sterile Hypodermic Syringes for Single Use" (K221079). It focuses on demonstrating substantial equivalence to a predicate device (K180417) rather than providing detailed acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

Therefore, many of the requested categories for acceptance criteria and study details for an AI/algorithm device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this submission.

However, I can extract the relevant information regarding the performance criteria and the non-clinical studies conducted to demonstrate its safety and effectiveness against recognized standards.

Here's the breakdown of the available information:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document pertains to a physical medical device (syringes), not an AI/algorithm. Performance is demonstrated through non-clinical laboratory testing of the manufactured product, not data analysis of a test set in the context of AI. The country of origin for the device manufacturer is China (Sichuan Prius Biotechnology Co., Ltd.). The studies are non-clinical, involving physical testing of the device.

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. Ground truth, in the context of AI/algorithm performance, is not relevant here. Performance is measured against recognized industry standards and validated laboratory methods for physical device characteristics (e.g., sterility, biocompatibility, mechanical performance).

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

• Not Applicable. Adjudication is a method for resolving discrepancies in expert labeling or diagnoses used in AI/algorithm studies. It is not relevant for the non-clinical testing of a physical device.

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 a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.

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

• Not Applicable. This refers to the performance of an AI algorithm. This submission is for a physical syringe.

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

• For the performance of this physical device, the "ground truth" is defined by compliance with established international and national standards (e.g., ISO for syringe performance, biocompatibility, sterility; USP for particulate matter and endotoxins) and validated test methodologies.

8. The sample size for the training set

• Not Applicable. Training sets are used for machine learning. This submission is for a sterile syringe.

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

• Not Applicable. This question relates to AI/machine learning model development, which is not relevant to this medical device submission.

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The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for general purpose fluid injection/ aspiration.

The Sterile Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle and a needle hub. The proposed device is available in variety of needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe.

This information is pertaining to a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needles for Single Use." This is a regulatory submission for a device, not a study of an AI algorithm. Therefore, many of the requested categories are not applicable.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device was tested against recognized international standards for hypodermic needles. The "reported device performance" is essentially that the device "complied with" these standards.

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

• The document does not specify the exact sample sizes for each non-clinical test. It states that tests were "conducted" and "met" or "complied" with standards.
• Data Provenance: The document does not explicitly state the country of origin for the data (beyond the manufacturer being in China), nor whether it was retrospective or prospective. Given it's a 510(k) submission, the testing would generally be prospective to demonstrate compliance with standards.

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

• This is not applicable as this is not a study involving ground truth established by human experts for interpretive tasks. The evaluation is based on objective measurements against engineering and biological standards.

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

• Not applicable for non-clinical engineering and biological tests.

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 or an MRMC study.

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.):

• The "ground truth" for this device's evaluation consists of the acceptance limits and methodologies defined by recognized international and national standards (e.g., ISO, USP, ASTM). The device's performance is measured against these objective criteria.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model; therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Sterile Safety Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose which consists of 1) Needle, 2) Safety shield, 3) Protective Cap, 4) Needle Hub. The proposed device is available in a variety needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

This device, Sterile Safety Hypodermic Needles for Single Use (K221080), is a medical device and therefore its acceptance criteria and validation studies are primarily focused on demonstrating its safety and effectiveness, often by showing substantial equivalence to a legally marketed predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on compliance with recognized international standards and demonstration of comparable performance to the predicate device.

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

The document specifies "test sets" for various non-clinical tests. However, it does not provide specific numerical sample sizes for each test. For example, it states:

• Simulated Clinical Study: "A simulated clinical study was performed on proposed device according to FDA Guidance... and ISO 23908:2011 to evaluate the safety mechanism of the proposed device."
• Safety Feature Test: "The safety feature test was performed on both proposed device and predicate device..."
• Biocompatibility Testing: "The following testing was conducted: Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Material Mediated Toxicity."

The data provenance is retrospective in the sense that these are non-clinical (laboratory/bench) tests conducted by the manufacturer as part of the premarket submission. The country of origin of the data is not explicitly stated for each test, but the manufacturing company (Sichuan Prius Biotechnology Co., Ltd.) is based in China. The adherence to international ISO and ASTM standards implies a global applicability of the testing methodologies.

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

This type of device (hypodermic needle) does not involve subjective interpretation or a "ground truth" derived from human experts in the same way an AI diagnostic device would. The "ground truth" for these tests are the objective acceptance criteria defined by the recognized standards (e.g., a specific force required for needle penetration, a certain level of extractable chemicals, or a maximum particle count). Therefore, no human experts were used to establish ground truth in the context of diagnostic interpretation. The experts involved would be those performing and interpreting the bench and lab tests according to the standards, but not interpreting "cases" for a diagnostic task.

4. Adjudication method for the test set

Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations for a test set. The tests are objective measurements against established international standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a sterile safety hypodermic needle, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily objective metrics derived from recognized international standards (e.g., ISO, ASTM, USP) and the FDA's guidance documents. These standards define measurable acceptance criteria for device performance, safety features, biocompatibility, sterility, and shelf-life.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument evaluated through non-clinical testing against standards, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

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The surgical mask is 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, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.

The provided text is a 510(k) Summary for a Surgical Mask (K210908). This document describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML-based medical device.

Therefore, the information requested in your prompt regarding acceptance criteria and study proving an AI/ML device meets them (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

The document focuses on the physical and biological performance characteristics of the surgical masks. Here's a breakdown of the relevant information provided in relation to performance, but specifically for a surgical mask, not an AI device:

1. Table of acceptance criteria and reported device performance (for the Surgical Mask):

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