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The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein under the action of gravity.

The device is a Disposable infusion set with needle. Its configuration includes a Protective Cap of Closure-piercing Device, Closure-piercing Device, Clamp, Fluid channel (tubing), Drip chamber upper cover (including the dropper), Drip chamber, Drip chamber base (including Fluid Filter membrane), Flow regulator, Regulator wheel, Luer Lock Connector, Infusion needle hub, Needle tube, Plastic needle handle, Infusion needle protector, Integral air-inlet with air filter and closure, Tubing, Lubricant, and Adhesives. It has a Tubing Diameter of 4 mm and Filter Characteristics of 15µm. It is available in various Needle Gauges and Lengths.

The provided document is a 510(k) summary for a "Disposable infusion set with needle," which is a Class II medical device. This type of device is a physical medical device, not an AI/software device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sample sizes for AI, etc.) is not applicable to this document.

The document discusses physical, mechanical, chemical, and biocompatibility testing according to various ISO and ASTM standards to demonstrate substantial equivalence to a predicate device.

However, to address the spirit of the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical medical device as described in this document, I can extract the relevant performance criteria and testing methods from the provided text.

Here's an interpretation based on the provided content for a physical medical device:

Acceptance Criteria and Device Performance for a Disposable Infusion Set with Needle

This document describes the regulatory submission for a Disposable Infusion Set with Needle (K232475) to demonstrate substantial equivalence to a predicate device (K163160). The "acceptance criteria" here refer to the performance requirements established by recognized standards, and the "study" refers to non-clinical performance testing conducted to prove the device meets these criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

The document presents a comparison between the predicate device and the subject device, outlining various performance parameters. The "acceptance criteria" for the subject device are generally implied to be meeting the same performance standards as the predicate, or demonstrating that any differences do not adversely affect safety or performance, as evaluated against relevant ISO and ASRM standards.

"Reported Device Performance" is indicated by the statement that the subject device "met all design specifications as Substantially Equivalent (SE) to the predicate device" and that "The requirements of the standards are met." Specific quantitative results are generally not provided in this summary, but rather a confirmation of compliance.

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 test (e.g., number of infusion sets tested for leakage, tensile strength, etc.). It generally refers to compliance with recognized standards (e.g., ISO 8536-4, ISO 7864), which themselves specify required sample sizes for testing.

• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Shandong Zhushi Pharmaceutical Group Co., Ltd. in China. The data would be derived from these internal tests. The term "retrospective or prospective" is not applicable to this type of device performance testing.

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. For a physical medical device like an infusion set, "ground truth" is established by direct physical, chemical, and biological testing against engineering and safety standards, not by expert consensus or interpretation of images. The tests evaluate measurable properties (e.g., tensile strength, flow rate, particulate count, presence of toxins) directly.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) where there might be inter-reader variability. For physical device performance testing, results are typically objective measurements or observations against predefined pass/fail criteria from a standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This question is not applicable. MRMC studies are used to assess the performance of diagnostic devices or AI systems, particularly how human readers perform with and without AI assistance on cases. This device is an infusion set, not a diagnostic or AI-enabled device.

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

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

7. The type of ground truth used

For this physical medical device, the "ground truth" is defined by:

• Established Industry Standards: Such as ISO 8536-4, ISO 7864, ISO 9626, USP NF , USP NF , ISO 10993 series, ASTM F1929, ASTM F88, etc. These standards specify acceptable ranges, limits, or characteristics for device performance and material safety.
• Direct Measurement and Observation: Performance is determined by physical tests (e.g., measuring tensile strength, observing leakage), chemical analyses (e.g., residual EO, particulate count), and biological assays (e.g., cytotoxicity, pyrogen testing).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a physical medical device. This term refers to data used to train an AI algorithm.

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

This question is not applicable for the same reason as #8.

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The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body.

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin.

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

• Disposable Sterile Syringe, with/without needle; luer/luer-lock: Piston, Plunger, Barrel. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Length 83-152mm, Diameter 50-31mm, Tip type luer/luer-lock, Needle tip configuration long bevel angle, Nozzle type Luer / Lock, 6% conical, 1,2 mm, Barrel marking specs 0.01ml-0.5ml, Graduation legibility Legible, Needle cover color Transparent, Lubricant composition Dimethicone, Barrel transparency Transparent/ UV resistant, Needle cover strength 15N (min. 2N max. 15N), Hub/needle bond strength min. 22-69 N. Complied with ISO 7886-1, ISO 7864, ISO 9626. Volume 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G. Needle Lengths 13-38 mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material PP, SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

• Sterile Insulin Syringe for Single use, with needle: Needle Cap, Needle, Piston, Plunger, Barrel, End Cap. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Complied with ISO 8537. Volume 0.5ml, 1ml volumes with fixed needle. Needle Lengths 8mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material SUS304, Needle Cap material PE, End Cap material PE. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical effect).

• Sterile Hypodermic needle for Single use: Protective cap, Needle, Adhesives, Needle hub. EO Sterilized. Prescription use. Medical professionals and trained care givers. Protective cap, Needle, Adhesives, Needle hub. Single use. For Manual Use Only, For Single Use only. Complied with: ISO 7864, ISO 9626. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G. Needle Lengths 13-38 mm. Protective cap materials PP, Adhesive Epoxy resin, Needle Hub materials PP, Needle material SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

The provided text is a 510(k) summary for medical devices (syringes and needles). It does not describe a study involving an AI model or a device that uses AI. Instead, it focuses on demonstrating substantial equivalence of the submitted devices to a predicate device through performance testing against established international standards for medical devices.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document. The document primarily details the physical and performance specifications of the syringes and needles themselves.

To directly answer your request based on the provided document, I must state that the information related to AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not present in the provided text. The document describes a traditional medical device submission, not an AI/ML-enabled medical device.

However, I can extract the acceptance criteria and performance data for the physical medical devices described:

Acceptance Criteria and Device Performance for Physical Medical Devices

The acceptance criteria for these devices are defined by compliance with a series of international ISO standards and USP guidelines. The "device performance" is reported as having "complied with" these standards. No specific quantitative performance metrics (e.g., accuracy, precision, etc.) are provided in a numerical table format for an AI algorithm, as this is not an AI device.

Table of Acceptance Criteria and Reported Device Performance

Regarding an AI-enabled device and its study, the following information is NOT available in the provided document:

• 1. Table of acceptance criteria and reported device performance for an AI model: Not applicable, as this is not an AI device.
• 2. Sample size used for the test set and data provenance: No test set for an AI model is mentioned. The performance testing refers to physical tests on the medical devices themselves.
• 3. Number of experts used to establish ground truth & qualifications: Not applicable for an AI model's ground truth. The ground truth for the physical devices' performance is established by the specifications and test methods within the referenced ISO standards.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No prospective clinical trials were conducted in support of this 510(K)."
• 6. If a standalone (algorithm only) performance was done: Not applicable, as there is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical devices, the "ground truth" is adherence to established engineering and material standards for safety and performance (e.g., fluid aspiration/injection, material biocompatibility, sterility).
• 8. The sample size for the training set: Not applicable, as there is no AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI model.

In summary, the provided document details a 510(k) submission for conventional medical devices (syringes and needles) and their compliance with relevant international standards, not an AI-enabled medical device. Therefore, the specific criteria requested for AI devices are not found within this text.

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The Disposable Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.

The Disposable Surgical Gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of polyester elastic closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown

This document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is about the physical and performance characteristics of a surgical gown, not a diagnostic AI device requiring complex clinical studies or expert ground truth.

Therefore, many of the requested categories for AI/diagnostic device evaluation (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable to this type of medical device submission.

The "acceptance criteria" for this device are defined by a series of standardized non-clinical tests that measure physical properties and barrier performance.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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 Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.

The document describes the acceptance criteria and performance of a "Disposable Surgical Face Mask" (K210643) compared to a predicate device (K203200).

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with tie on and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. During use, the tie on shall be tied over user head. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.

The provided text is a 510(k) Summary for a Disposable Surgical Face Mask, which is a medical device. This document describes the non-clinical testing performed to demonstrate that the device meets specific performance criteria, primarily based on recognized standards for surgical masks.

It is crucial to understand that this document DOES NOT describe a study involving AI, human readers, or image analysis. Instead, it focuses on the physical and biological characteristics of a surgical mask. Therefore, many of the requested points regarding AI/human reader studies are not applicable to the information contained in this document.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance (for a Disposable Surgical Face Mask)

This document details acceptance criteria and performance for a surgical face mask, not an AI-based device.

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing

Since this document pertains to a physical medical device (a surgical mask) and not an AI/software device, the following points are not applicable (N/A) based on the provided text.

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

N/A - This document describes testing on physical samples of surgical masks, not a data-driven test set for a software/AI device. The text indicates "31 of 32 test articles passed" for the synthetic blood penetration test, which implies a test sample size of 32 masks for that specific test. Data provenance like country of origin for the data is not relevant here as it's about physical product testing.

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

N/A - Ground truth for a physical device like a surgical mask is established by validated laboratory test methods and compliance with recognized standards (e.g., ASTM F2100-19), not by expert consensus in a medical imaging context.

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

N/A - Adjudication methods are relevant for subjective assessments, typically in medical imaging or clinical trials where human interpretation is involved. This is laboratory testing of a physical product.

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:

N/A - This device is a surgical mask, not an AI system. No MRMC study was conducted.

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

N/A - As above, 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/acceptance criteria for the surgical mask performance is based on recognized industry standards (ASTM F2100-19) and guidelines for medical devices (ISO 10993 for biocompatibility), which specify quantitative and qualitative outcomes for the physical and biological properties of the mask.

8. The sample size for the training set:

N/A - There is no "training set" as this is not an AI/machine learning device. The document describes product manufacturing and testing.

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

N/A - No training set.

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Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

The Infrared Thermometer, Model ZST-A is a non-contact long-distance infrared thermometer which is specialized in measuring human body temperature. It contains buzzer prompt, memory reading, backlight reminder, temperature offset setting, alarm threshold setting, automatic shutdown and common functions of equipment. The Infrared Thermometer measures the temperature by using the principle of receiving infrared. The product is composed of built-in infrared detector and related hardware and software, which can receive, analyze and record the measured object and ambient temperature. Therefore, once the user approaches the specific part of the human body (forehead) and presses the measurement key, the infrared sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the passive infrared sensor, so as to accurately measure the body temperature of the human body. The measurement distance of the subject device is 1~5 cm from the middle of the forehead.

The provided document is a 510(k) summary for an Infrared Thermometer (Model: ZST-A). It details the device's technical specifications, intended use, and comparison to a predicate device, along with non-clinical and clinical test conclusions.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

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

The primary acceptance criteria for the infrared thermometer are related to its accuracy in measuring human body temperature. The standard referenced is ASTM E1965-98.

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

• Sample Size: A minimum of 105 subjects were used for the clinical study. These subjects were divided into three age groups, with at least 35 subjects per group.
• Data Provenance: The document does not explicitly state the country of origin where the clinical study was conducted. It mentions "Shandong Zhushi Pharmaceutical Group Co., Ltd." in China as the submitter, which implies the study could have been performed in China, but this is not definitively stated for the clinical trial location. The study is described as a "clinical investigation," which generally implies prospective data collection, but the document does not explicitly specify "retrospective" or "prospective." However, clinical trials are typically prospective.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical test set. For temperature measurement, the ground truth is typically established using a reference thermometer (e.g., a rectal thermometer for core body temperature, as per ASTM standards for clinical thermometry studies) rather than expert consensus.

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

The document does not describe any adjudication method. This is typically not relevant for a temperature measurement device where a reference standard device provides the "ground truth" rather than human interpretation.

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 an infrared thermometer. An MRMC study is typically performed for AI-powered diagnostic imaging devices where human readers (e.g., radiologists) interpret images with or without AI assistance. The Infrared Thermometer is a direct measurement device and does not involve human interpretation of complex data that AI would assist with.

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

The device itself, the "Infrared Thermometer," operates as a standalone device. Its performance is measured directly (algorithm only, as it's an embedded system) without continuous human interaction in the measurement process other than positioning and activating the device. The clinical study assessed the device's accuracy against a recognized standard (ASTM E1965-98), which inherently evaluates its standalone performance.

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

The ground truth for the clinical study would have been established by a reference clinical thermometer (e.g., a rectal or oral thermometer depending on the specific ASTM E1965-98 protocol used), which is considered the gold standard for core body temperature measurement in such studies. The document states that the clinical study was conducted "per ASTM E1965-98." This standard details the methodology for clinical accuracy assessment for infrared thermometers, which involves comparing measurements from the test device to core body temperatures obtained from a highly accurate reference thermometer.

8. The sample size for the training set:

The document does not mention a training set or any machine learning/AI training process in the conventional sense. This device is a traditional infrared thermometer, not an AI/ML-based diagnostic tool that would typically have a separate training phase. Its operation is based on established physical principles of infrared radiation detection and calibrated algorithms, not learned patterns from a large training dataset.

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

As no training set is mentioned or implied for this type of device, this point is not applicable.

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The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

This document is a 510(k) Premarket Notification for "Disposable Nitrile Examination Gloves" (K203436) by Shandong Zhushi Pharmaceutical Group Co., Ltd. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (K171422).

The 510(k) submission primarily relies on non-clinical performance testing to demonstrate safety and effectiveness.

Here's an analysis based on your request, focusing on acceptance criteria and study proving device meets criteria:

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

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The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text describes the acceptance criteria and a study for Disposable Vinyl Examination Gloves. It is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the requested information:

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

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