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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, connected with a luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.

This document outlines the acceptance criteria and supporting study details for a Sterile Hypodermic Needle for Single Use (K231720) according to its 510(k) summary. This is not an AI/ML-based device, so many of the requested fields (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for AI training/test sets) are not applicable.

The "device" in question is a physical medical device (hypodermic needles), not a software or AI-driven system. Therefore, the acceptance criteria and study descriptions are focused on physical and biological performance, rather than algorithm performance.

Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K231720)

The substantial equivalence determination for this device is based on its compliance with established international and national standards for medical devices, rather than a comparative effectiveness study involving human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. Testing of physical medical devices typically involves testing a statistically significant sample size from a production lot to demonstrate compliance with standards. The data provenance is implied to be from laboratory testing performed on the manufacturer's device, likely in China (where the manufacturer is located). The testing is prospective for the purpose of demonstrating compliance for this specific device model.

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

This information is not applicable as the device is a physical medical device (hypodermic needle), not an AI/ML diagnostic or image analysis system. Ground truth is established through validated laboratory test methods and established international/national standards, not through expert consensus in the medical imaging context.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established through objective laboratory testing against defined standards (e.g., ISO, ASTM, USP), not through the adjudication of medical opinion.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids that assist human readers in interpreting medical images. This device is a sterile hypodermic needle, a physical disposable medical tool.

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

No, a standalone performance evaluation in the context of an AI algorithm was not done. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 10993, ISO 7864, ISO 9626, ISO 80369, ASTM, USP). These standards define the physical, chemical, and biological properties a device must meet to be considered safe and effective for its intended use. Testing protocols outlined within these standards serve as the objective 'ground truth' against which the device's performance is measured. Compliance is determined by the device meeting all the specified numerical and qualitative requirements of these standards.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of a physical medical device. The manufacturing process is controlled by Good Manufacturing Practices (GMP) and validated testing, not machine learning training.

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

This information is not applicable as there is no "training set" involved in the development or evaluation of this physical medical device.

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The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration 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 Safety Hypodermic Needles for Single Use are composed of a hypodermic needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety 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.

This is an FDA 510(k) clearance letter for a medical device, specifically Sterile Safety Hypodermic Needles for Single Use. The primary purpose of this document is to establish substantial equivalence to a predicate device, not to present a detailed study on the device's original performance against a specific set of acceptance criteria with explicit human reader performance metrics, as would be typical for an AI/ML medical device.

Therefore, many of the requested items (e.g., sample size for test set with ground truth, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device clearance and the information provided in this document.

However, I can extract the acceptance criteria and performance data that are relevant to this type of conventional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
This document describes a premarket notification for a conventional medical device (hypodermic needles), not an AI/ML device. Therefore, there isn't a "test set" in the context of diagnostic performance evaluation with specific data provenance (country of origin, retrospective/prospective clinical data) as requested. The performance is assessed through engineering and biological testing against established international and national standards. The sample sizes for these tests would be determined by the specific standards and protocols followed (e.g., number of units tested for particulate matter, tensile strength, sterility, etc.), but are not detailed in this summary.

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 AI/ML, refers to a definitive diagnosis or finding. For this device, ground truth is established by objective measurements and standardized testing against predefined physical, chemical, and biological properties as specified in the referenced ISO, ASTM, and USP standards. The "experts" involved would be the qualified personnel performing the laboratory and engineering tests, whose qualifications are implicit in their ability to conduct these standardized tests accurately.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device does not involve human interpretation of outputs that would require adjudication for establishing ground truth in a diagnostic context.

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, and no human reader studies are mentioned or relevant for its clearance.

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 (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by objective measurements and results from standardized laboratory and engineering tests (e.g., sterility testing, material strength, biocompatibility assays, particulate counts, sharps injury prevention mechanism functionality) against predefined acceptance criteria established in international and national standards.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device clearance.

9. How the ground truth for the training set was established:
Not applicable.

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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 plunger can be locked for self-locking.

The provided text describes a 510(k) premarket notification for a medical device: Sterile Auto-Disable Syringes with/without Needle for Single Use. The FDA clearance letter indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Safety Auto-Disable Syringe with Needle (Auto-Lock), K143497).

However, the provided document does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device. The document is a regulatory submission for a physical medical device (syringes) and details its physical, material, and performance characteristics compared to a predicate device.

Specifically, the document discusses:

• Device Description: The physical components and mechanism of the auto-disable syringe.
• Indications for Use: Aspiration of fluids and fluid injections.
• Comparison to Predicate Device: Detailed table comparing features like indications for use, product code, regulation number, class, principle of operation, safety features, intended user, environment of use, syringe volume, nozzle type, lubricant, barrel transparency, graduations legibility, needle length, needle gauge, configuration of the tip, needle hub, single use, performance specifications, sterilization, SAL, materials, pyrogenicity, biocompatibility, and labeling.
• Performance Data: Lists various tests conducted to demonstrate the physical device's safety and bio-compatibility, such as biocompatibility testing (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogens, Hemolysis, Particulate Matter), sterilization validation, shipping and shelf-life testing, and performance testing against ISO standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-4, ISO 7886-1).

None of the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device is present in this documentation. The questions about sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment are relevant to AI/ML device evaluations, but not to the type of device described in this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and validation using the provided text. The document is about the substantial equivalence of a physical syringe, not a software or AI/ML product.

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The Sterile syringes for single use with/without needle is 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.

This document is a 510(k) premarket notification for a medical device (Sterile syringes for single use with/without needle). It outlines the performance data provided to support the claim of substantial equivalence to a predicate device, rather than defining novel acceptance criteria for an AI/ML powered device and proving those are met.

Therefore, many of the requested details about acceptance criteria, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, and MRMC studies are not applicable or extractable from this specific document.

The document focuses on demonstrating that the new syringe device performs equivalently to existing legally marketed predicate devices by complying with established international and FDA-recognized standards for mechanical, physical, chemical, and biological properties.

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

What can be extracted:

• Device Name: Sterile syringes for single use with/without needle
• Intended Use: "intended to be used for medical purposes to inject fluid into or withdraw fluid from body."
• Study Type: This is a premarket notification (510(k)) which relies on demonstrating substantial equivalence to a predicate device, not necessarily a de novo clinical study proving novel performance criteria for an AI/ML algorithm. The performance data is primarily for physical, chemical, and biological characteristics of the syringe, not AI/ML performance.
• Acceptance Criteria & Reported Performance Table: While not in the typical "AI/ML performance" format, the document lists specific standards and states that "All evaluation acceptance criteria were met."

• Ground Truth Type: For this device, the "ground truth" is defined by the established international standards and testing methodologies (e.g., ISO, ASTM, USP) for physical, chemical, and biological properties of syringes, rather than expert labels on medical images or outcomes data.
• Sample Size:
  • Test set: The document doesn't explicitly state sample sizes for each test, but implies that sufficient samples were tested to demonstrate compliance with the referenced standards. For example, "The shelf life of 5 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16," which would involve a specific number of samples over time.
  • Training set: Not applicable, as this is not an AI/ML device requiring a training set.
• Data Provenance: The manufacturing and testing entities are based in China (Wepon Medical Technology CO., Ltd. in Zhejiang, China, and Shanghai Ling Fu Technology Co., Ltd. in Shanghai, China). The data would be retrospective in the sense that it was collected during product development and validation for submission, rather than a prospective clinical trial.

What cannot be extracted (because it's not an AI/ML device):

• Number of experts used to establish ground truth & qualifications: Not applicable; ground truth is standard compliance.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) pertains to a conventional medical device (syringes) and demonstrates substantial equivalence by meeting recognized performance standards, not by evaluating an AI/ML algorithm's diagnostic or predictive capabilities.

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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 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 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 document is a 510(k) premarket notification for a Medical Surgical Mask. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the request asks for information regarding an AI/Software as a Medical Device (SaMD) study, specifically about acceptance criteria, ground truth establishment, sample sizes for training and testing, expert qualifications, and potential MRMC studies.

The provided document is NOT for an AI/SaMD device. It is for a physical medical device (a surgical mask) and therefore does not contain any of the information requested about AI/SaMD acceptance criteria or study methodologies.

Therefore, I cannot fulfill the request using the provided text. The document discusses:

• Acceptance Criteria (for a physical surgical mask): These are performance standards like Bacterial Filtration Efficiency (BFE), Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flame Spread, as well as Biocompatibility.
• Device Performance: The document states "Passed" for all the listed performance tests against the specified acceptance criteria for Level 2 and Level 3 masks.
• Study That Proves the Device Meets Acceptance Criteria: This is the "Non-Clinical Test Conclusion" section (pages 4-5), where various physical and biological tests were performed according to recognized standards (e.g., ASTM F2101, EN14683, ASTM F1862, 16CFR Part 1610, ISO 10993).

To explicitly address the numbered points in the prompt based on the provided document (even though it's not an AI/SaMD):

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

   Performance Testing	Purpose	Acceptance Criteria for Level 2 Barrier	Acceptance Criteria for Level 3 Barrier	Result
   Bacterial Filtration Efficiency ASTM F2101	Measure bacterial filtration efficiency	≥98%	≥98%	Passed
   Differential Pressure (mm H2O/cm2)	Determine breathability of a mask	<6.0 H2O/cm²	<6.0 H2O/cm²	Passed
   Sub-micron Particulate Filtration Efficiency ASTM F2299/F2299M-03	Measure initial particle filtration efficiency	≥98%	≥98%	Passed
   Resistance to Penetration by Synthetic Blood ASTM F1862/F1862M-2017	Evaluate the resistance to penetration by impact of small volume of synthetic blood	120 mmHg	160 mmHg	Passed
   Flame spread 16CFR Part 1610-2008	Response of materials to heat and flame	Class I	Class I	Passed

   Biocompatibility Acceptance Criteria and Results:

   Biocompatibility Evaluation	Biological Effect	Standard	Results
   	Cytotoxicity	ISO 10993-5	Not cytotoxic
   	Sensitization	ISO 10993-10	Non sensitizing
   	Irritation	ISO 10993-10	Negligibly irritating

2. Sample sizes used for the test set and the data provenance: The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many masks were tested for BFE). It also does not specify the country of origin of the data or whether the testing was retrospective or prospective, though it implicitly describes a prospective testing process for compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the type of device. The "ground truth" for a surgical mask's performance is established by standardized test methodologies and equipment, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical performance 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 device is not an AI/SaMD, so no MRMC study or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI/SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is determined by adherence to established, quantitative non-clinical testing standards and their respective measurement methods. For biocompatibility, it's based on biological responses in standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set: Not applicable. There is no AI/ML model for this physical device that would require a "training set."

9. How the ground truth for the training set was established: Not applicable.

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