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Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.

Sterile Syringe with Fixed Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe and fixed needle with a safety mechanism. 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.

The proposed device is available in a variety combination of syringe volume and needle size.

This document is a 510(k) Premarket Notification from Gemtier Medical (Shanghai) Inc. for a "Sterile Syringe with Fixed Safety Needle for Single Use." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about an AI/ML-driven medical device. The acceptance criteria and study described are for a physical medical device (syringe and safety needle), focusing on its mechanical, material, and safety performance, rather than an AI algorithm's performance on data.

Therefore, I cannot provide the detailed information requested in the prompt, as it pertains to AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types).

The document specifically mentions:

• No clinical study is included in this submission. (Page 10)
• The studies performed are non-clinical tests verifying the physical device's specifications, such as needle performance according to ISO standards, syringe performance, sharp injury protection, simulated clinical study for the safety feature, biocompatibility testing, sterility, shipping, and shelf-life. (Pages 8-9)

Because the provided text is about a physical medical device and not an AI/ML product, the questions related to AI/ML device performance and evaluation methodologies are not applicable.

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The Medical Face Masks are intended to be worn to protect both the patient and healthcare persomel 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. Face Masks are single use, disposable device, provided non-sterile.

The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (PTFE membrane filter) and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nosepiece (iron wire with white plastic covering) to provide a firm fit over the nose.

The provided text is a 510(k) summary for a Medical Face Mask (K202493). This document details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance tests.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The relevant information is presented under "Table 1 Summary of Performance Test" in the document.

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

The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the Fluid Resistance test, it mentions "32/32 passed at 160 mmHg", which implies a sample size of 32 for that specific test. The document focuses on demonstrating substantial equivalence through non-clinical testing against established standards, rather than new clinical trials with 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 provided in the document. The tests performed are laboratory-based and follow established international standards (ASTM, MIL-M, ISO, 16 CFR). These standards define the methodology and acceptance criteria, and their execution would typically be undertaken by trained laboratory technicians or scientists, rather than by medical experts establishing "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication method" usually refers to a process of resolving disagreements among experts when establishing ground truth for a test set, typically in a clinical or image-interpretation context. The tests described are objective, standardized laboratory tests with clear pass/fail 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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI systems on human performance in diagnostic tasks, which is not the purpose of this submission (which concerns a medical face mask).

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

No, a standalone (algorithm only) performance study was not done. This type of study is specifically for AI/software devices. The device in question is a physical medical face mask, and its performance is evaluated through physical and material tests, not algorithm performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed on the Medical Face Mask is based on objective, quantitative measurements in accordance with established international testing standards. For example:

• Bacterial Filtration Efficiency (BFE): Measured objectively as a percentage according to ASTM F2101.
• Differential Pressure: Measured objectively in mmH2O/cm² according to MIL-M-36954C.
• Particulate Filtration Efficiency (PFE): Measured objectively as a percentage according to ASTM F2299.
• Fluid Resistance: Measured objectively by resistance to synthetic blood penetration at a specific pressure (160 mmHg) according to ASTM F1862.
• Flammability: Objectively classified according to 16 CFR Part 1610.
• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Evaluated through standardized biological assays with defined endpoints (e.g., cell viability for cytotoxicity, irritation index for irritation), as per ISO 10993 series.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for these types of physical product performance tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms. The Medical Face Mask is a physical medical device, not an AI or software device, so there is no training set in this context.

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

This information is not applicable and therefore not provided, for the reasons mentioned in point 8.

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The 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. The Medical Face Masks are single use, disposable device, provided non-sterile.

The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer (meltblown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with white plastic covering) to provide a firm fit over the nose.

The provided text describes the acceptance criteria and performance data for a Medical Face Mask, not an AI-powered diagnostic device. Therefore, the questions related to AI device performance metrics, such as human reader improvement with AI assistance, standalone algorithm performance, AI training/test set details, and expert adjudication, are not applicable to this document.

However, I can extract the information relevant to the medical device's performance as described in the provided text.

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

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

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

The document does not specify general "sample sizes" for the test sets in the typical sense of a clinical trial. Instead, it references specific test methodologies with their own inherent sample requirements. For example:

• Resistance to penetration by synthetic blood (ASTM F1862): The result is "32/32 passed," indicating a sample size of 32 masks were tested.
• For other tests (BFE, PFE, Delta-P, Flammability, Biocompatibility), the specific sample sizes used for the tests are not explicitly stated, but the methodology standards (e.g., ASTM F2101, F2299, etc.) would define these.

Data Provenance: The document does not explicitly state the country of origin of the data for these performance tests. It mentions the manufacturer is Gemtier Medical (Shanghai) Inc. in China. The testing was non-clinical. The document implies these tests were conducted as part of the submission to the FDA. It does not mention if the data was retrospective or prospective, as these terms are typically reserved for clinical studies.

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

This question is not applicable. The device is a medical face mask, and its performance acceptance is based on objective, standardized laboratory tests (e.g., filtration efficiency, fluid resistance, biocompatibility), not on expert interpretations of data like in an AI diagnostic setting.

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

Not applicable. This is a non-clinical device performance study based on standardized test methodologies, not a study involving human readers or subjective interpretations that would require 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

Not applicable. This document pertains to the regulatory submission for a medical face mask, not an AI-assisted diagnostic device. No human reader studies (MRMC) were conducted or are relevant.

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

Not applicable. This is not an algorithmic device. The performance data presented is for the physical medical face mask.

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

The "ground truth" for the device's performance is established by adherence to recognized international and national standards for medical face masks and biological evaluation. These standards define the specific methodologies and acceptance criteria for measuring characteristics like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, flammability, and biocompatibility. For example:

• ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR Part 1610 (for physical properties)
• ISO 10993-1, ISO 10993-5, ISO 10993-10 (for biological evaluation)

The performance results are objectively measured against these predefined thresholds, rather than based on subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

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

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

Not applicable. As this is not an AI system, there is no training set or associated ground truth establishment process.

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Sterile Syringe with Safety needle for Single Use in the aspiration and injection of fluids for medical purpose. 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.

Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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.

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

The Sterile Syringe for Single Use is intended for manual and single use only, which consists of piston, barrel and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock, which is intended to be connected with a hypodermic needle.

Sterile Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a 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.

The provided text describes a submission for K192679 (Sterile Syringe with Safety Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use) to the FDA, asserting substantial equivalence to predicate device K170651.

The document discusses acceptance criteria for various tests and confirms that the proposed device met these criteria through non-clinical testing and a simulated clinical study.

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

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

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

The document does not explicitly state the numerical sample sizes for each test set. It mentions tests were performed on the "proposed device" and "aging samples" for shelf-life. In the Safety Feature Test, tests were performed on "both proposed device and predicate device".

The data provenance is from non-clinical tests conducted by Gemtier Medical (Shanghai) Inc. in China (manufacturer location). The nature of these tests (bench testing, simulated clinical study) implies they are prospective in execution, meaning they were designed and performed for the purpose of this submission.

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 section is not applicable as the document describes non-clinical and simulated clinical studies for a medical device (syringes and needles), not studies involving human subjects or expert assessment of medical images/data for ground truth. The acceptance criteria are based on compliance with international standards and internal design specifications, not expert consensus on medical conditions.

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

This section is not applicable. Adjudication methods are typically used in clinical studies or studies where subjective interpretations need to be resolved. The tests described here are objective performance measurements against established 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

This is not applicable. The device is a sterile syringe and needle system, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical medical instrument, 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 the international standards (e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 10993-7, ISO 23908, ISO 80369-7) and internal design specifications against which the device was tested. For biocompatibility, the lack of "negative impacts" is the ground truth. For the safety mechanism, meeting "pre-established criteria" of relevant guidance documents serves as the ground truth.

8. The sample size for the training set

This is not applicable. The document describes the testing and comparison of a physical medical device. There is no training set mentioned, as this is not an AI/ML device.

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

This is not applicable as there is no training set for this device.

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The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is a single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The venipuncture needle is designed to be covered with a safety mechanism, which can be activated to cover needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Device for Single Use is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The Safety Blood Collection/Infusion Set is individually wrapped, sterile, non-pyrogenic and is designed for collection of blood specimens or short-term intravenous administration of fluid (up to 2 hours under direct clinical supervision). When it's equipped with male luer adapter and/ or tube holder, it can be used for taking samples from the patients through vacuum tubes. It is also indicated for short-term intravenous fluids (up to 2 hours under direct clinical supervision) after attaching to an IV set, a transfusion set or to other compatible/appropriate device.

Three models were included in this submission, which are JT-HSQ, JT-HSQ-B, and JT-HSQ-Z.

The provided text is a 510(k) Summary for a medical device called "Safety Blood Collection Device for Single Use." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than presenting a clinical study with acceptance criteria and comparative human reader performance as one might find for an AI/ML medical device.

Therefore, many of the requested details, such as sample size for test sets (in the context of clinical studies), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or not provided in this document. The document describes bench testing of physical and chemical properties and biocompatibility, not clinical performance for diagnostic accuracy or human-in-the-loop performance.

Here's an analysis based on the provided text, addressing what can be inferred and highlighting what is absent:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

The acceptance criteria are implicitly defined by the successful adherence to recognized international standards and FDA guidance documents for medical devices of this type. The reported device performance is that it met the requirements of these standards and guidance documents.

Since this premarket notification is for a conventional medical device (safety blood collection device) and not an AI/ML-based diagnostic or imaging device, the following points are largely not applicable or not detailed in the submission.

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

   • The document mentions "test devices" for performance testing and "samples" for biocompatibility but does not specify the number of units or lot sizes tested for each standard.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not applicable given this is hardware testing against engineering standards, not patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance and biocompatibility is established by adherence to international engineering and biological safety standards, not expert consensus on clinical data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench testing.

4. 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/ML diagnostic tool.

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

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

   • For biocompatibility: Ground truth is established by the results of standardized biological tests (e.g., cell cultures, animal irritability tests) that comply with ISO 10993 series.
   • For performance: Ground truth is established by meeting the quantified specifications and thresholds defined within various ISO engineering standards (e.g., tensile strength, flow rate, dimensions).

7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

8. 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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