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The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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(s), provided non-sterile.

The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and 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 are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.

The provided FDA 510(k) summary for the Azur Medical Company Inc. Medical Surgical Mask (K231719) details the acceptance criteria and study results for the device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask with two types: Level 2 and Level 3, based on ASTM F2100-19.
The table below combines information from the "VII Comparison of technological characteristics with the predicate device" and "VIII Summary of Non-Clinical Tests" sections. Note that for some performance characteristics, the specific numerical results are given in comparison to the predicate, while for others, only "Pass" is stated against the acceptance criteria.

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many masks were tested for PFE, BFE, etc.). It only reports the overall "Test results" as "Pass" or an average value for the proposed device.

The data provenance is not specified in terms of country of origin, but the testing would typically be performed by accredited labs. The studies described are non-clinical (laboratory-based performance testing and biocompatibility testing), not clinical trials, so the terms "retrospective" or "prospective" do not apply in the same way they would for patient data.

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 to this document. The "ground truth" for non-clinical testing of a surgical mask is established by validated standardized test methods (e.g., ASTM, ISO standards) and their defined acceptance criteria. It does not involve expert consensus in the way clinical diagnostic studies might.

4. Adjudication Method for the Test Set

This is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently review cases and then resolve discrepancies. Non-clinical performance tests follow predefined protocols and acceptance 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

This is not applicable to this document. This submission is for a physical medical device (surgical masks), not an AI/software as a medical device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant.

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

This is not applicable to this document. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth for this device's evaluation is based on standardized test methods and their defined performance criteria, primarily from ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:

• Particulate Filtration Efficiency: ASTM F2299/F2299M-03
• Differential Pressure: ASTM F2100: 2019
• Bacterial Filtration Efficiency: ASTM F2101: 2019
• Flammability: 16 CFR Part 1610
• Synthetic Blood Penetration Resistance: ASTM F1862/F1862M-17
• Biocompatibility: ISO 10993 series (ISO10993-5, ISO10993-23, ISO10993-10)

These standards define the methodology and the quantitative or qualitative criteria for "passing" the test, which serves as the ground truth.

8. The Sample Size for the Training Set

This is not applicable to this document. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML device, so there is no training set in this context.

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

This is not applicable to this document, as there is no training set for an AI/ML model for this device.

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The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided text describes a 510(k) premarket notification for a medical device called "Sterile Auto-Disable Syringes with/without Needle for Single Use." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information details the device, its intended use, and a comparison to the predicate, along with performance testing conducted.

Here's an analysis of the provided text in relation to your request for acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" with numerical targets in a tabular format as you might expect for a specific performance metric (e.g., "accuracy > 90%"). Instead, it states that the device's performance "complies with" or "conforms to" various ISO standards. For medical devices like syringes, these standards themselves define the performance requirements and test methods. Therefore, the "acceptance criteria" are implicitly the requirements set forth by these international standards, and the "reported device performance" is that the device meets those standards.

Below is a table constructed from the "Performance testing" section, indicating the relevant standards as acceptance criteria and the reported performance as compliance 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 any of the performance tests.
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). These details are typically found in the full test reports, which are summarized here.

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 to this type of device and study. The testing for a syringe involves physical, chemical, and biological performance against standardized criteria, not interpretation by human experts to establish a "ground truth" like in imaging or diagnostic studies. The "ground truth" is defined by the parameters and thresholds in the ISO and ASTM standards themselves.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth for subjective assessments. Since this study relies on objective performance against defined standards, there's no need for 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

This is not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation devices. This submission concerns sterile auto-disable syringes, which are physical medical devices, not diagnostic software.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the syringe device is defined by the requirements and test methods specified in the cited international ISO and ASTM standards. For example, for "Seal Strength," the ISO/ASTM standard dictates the method and acceptable range, which serves as the objective ground truth. For "Biocompatibility," the ground truth is whether the device materials elicit a toxic response beyond defined limits, as determined by standardized biological tests.

8. The sample size for the training set

This is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

This is not applicable for the reason stated above.

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

The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing. The Sterile Hypodermic Needles for Single Use is for single use only, It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.

The provided document, K211214, is an FDA 510(k) summary for a medical device: Sterile Hypodermic Needles for Single Use. This document outlines the manufacturer's claims that their device is substantially equivalent to an existing legally marketed predicate device (K180417 from Berpu Medical Technology Co., Ltd).

However, it's crucial to understand that this document describes a conventional medical device (a hypodermic needle), NOT an AI/ML-based device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI, ground truth establishment for training set) are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a physical medical device like a hypodermic needle are based on performance testing against recognized industry standards (ISO standards, USP standards), and biocompatibility, sterilization, and shelf-life testing. These are fundamentally different from the validation methods for AI/ML algorithms.

Here's a breakdown of the requested information based on the provided document, addressing what is relevant and explicitly stating what is not applicable:

Acceptance Criteria and Device Performance (for a Hypodermic Needle)

1. Table of Acceptance Criteria and Reported Device Performance

For this conventional medical device, the "acceptance criteria" are compliance with various ISO and USP standards for physical and biological properties. The "reported device performance" is a statement that the device "meets the requirements" or "acceptance criteria" of these standards.

Information Relevant to AI/ML Device Testing (Not Applicable to this Device)

The following points are typically relevant for AI/ML-based medical devices but are not applicable to this 510(k) submission concerning a sterile hypodermic needle.

2. Sample size used for the test set and the data provenance: Not applicable. Testing involves physical samples of needles, not data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a needle is based on objective physical and chemical measurements against standards, not expert interpretation of AI outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing a needle's compliance with ISO 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 is for AI-assisted diagnostic or interpretative devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a hypodermic needle, "ground truth" is established by the specifications and performance requirements defined in the international standards (e.g., ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 for biocompatibility) and direct physical/chemical measurements. It's not expert consensus on an image or pathology.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable. There is no AI model to train.

In summary: K211214 describes the regulatory clearance for a traditional medical device (hypodermic needle). The "acceptance criteria" and supporting "study" are engineering and biological validations demonstrating the device meets established international safety and performance standards for its physical form and intended use. The questions posed in your prompt are tailored for Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under a entirely different set of validation and regulatory expectations than conventional devices.

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The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The document describes the acceptance criteria and performance data for the "Sterile syringes for single use with/without needle," but it does not involve a study with a test set of data, ground truth, or expert consensus in the way that AI/ML device studies typically do. This is a traditional medical device (syringes) rather than an AI/ML diagnostic or prognostic tool.

Therefore, many of the requested fields are not applicable.

Here's the information extracted from the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated by compliance with various international standards and specific tests. The "acceptance criteria" are implied by the requirements of these standards.

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

• Sample Size: Not explicitly stated. The document refers to "testing" and "evaluations" according to various standards, which would define the sample sizes for those specific tests.
• Data Provenance: Not explicitly stated, but the testing was conducted to comply with international standards (ISO, ASTM, USP), indicating standard laboratory and manufacturing quality control procedures. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China, so likely some testing occurred there.

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

Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. This does not involve adjudication of expert readings.

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.

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

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

7. The type of ground truth used

The "ground truth" for this device's performance is established by its adherence to the technical and safety specifications outlined in the referenced international standards (e.g., ISO, ASTM, USP). For instance, the ground truth for "sterilization" is the result of tests confirming a certain sterility assurance level; for "biocompatibility," it's the outcome of biological tests.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

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

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