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The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.

The Angiography Injector is intended to provide the function of aspirating and injecting contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body. The proposed device is intended for single use and is provided sterile using EO sterilization.

The Angiography Injector consists of six components: 1) Piston, 2) Plunger cap, 3) Push-button 4) Barrel, 5) Plunger and 6) Adapter (rotating or fixed). The proposed device is available in volume of 6mL, 8mL, 10mL and 12mL.

The primary package is blister package and plastic paper package. The blister package and plastic paper package all consist of PE film and Tyvek®2FS paper.

The provided text is a 510(k) summary for a medical device called "Angiography Injector." This document describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the 510(k) summary does not contain information related to a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies (MRMC), or a detailed setup for establishing ground truth as typically observed in AI/ML medical device submissions.

The document discusses "acceptance criteria" only in the general sense of meeting design specifications and regulatory standards for a conventional angiography injector (e.g., biocompatibility testing results showing acceptance criteria met, performance tests meeting ISO 7886 requirements). It specifically states: "No clinical study is included in this submission."

Therefore, based on the provided text, I cannot answer the questions about:

• A table of acceptance criteria and reported device performance related to AI/ML or human reader studies.
• Sample sizes for test sets (for AI/ML).
• Data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for test sets.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
• Sample size for the training set (for AI/ML).
• How ground truth for the training set was established.

This is because the device described is a physical medical instrument (an angiography injector and syringe), not an AI/ML-driven diagnostic or assistive software. The "performance testing" mentioned refers to engineering and safety bench tests (e.g., force to operate piston, freedom from air/liquid leakage, sterility, biocompatibility etc.), not diagnostic performance on medical images.

In summary, the provided document does not support a response to the specific questions regarding AI/ML device performance or clinical study methodologies.

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100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.

The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.

The provided text is a 510(k) summary for a medical device (Disposable Syringe (Kit)) and does not contain information about an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and study details cannot be answered based on the provided input.

However, I can provide a summary of the non-clinical performance data presented for the Disposable Syringe (Kit), which demonstrates it meets its acceptance criteria based on established standards.

Non-Clinical Performance Data for Nemoto Disposable Syringe (Kit)

The Nemoto Disposable Syringe (Kit) underwent extensive non-clinical testing to demonstrate substantial equivalence to its predicate devices. The device passed numerous tests in accordance with internal requirements, national standards, and international standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for each non-clinical test. The tests are general performance and materials tests, not based on patient data.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. These are non-clinical engineering and laboratory tests, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method:
Not applicable. This is not a clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the specific parameters and thresholds set by the relevant ISO standards (e.g., ISO 10993, ISO 7886-1, ISO 8536-9, ISO 80369-7) and internal requirements. These standards specify acceptable limits for various properties like cytotoxicity, leakage, tensile strength, and dimensions.

8. Sample Size for Training Set:
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable.

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Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike.

Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector.

Compatibility is shown in the Table 1 Compatibility between Syringe and Injectors. (Note: the newly added and the difference between K211564 and the proposed device is highlighted in Red.)

Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe. The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube. (Note: the newly added and the difference between K211564 and proposed device is highlighted in Red)

J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation.

Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation. The pressure specification for the spike is provided in the following table as Table 3 Pressure Specifications for Spike (Note: this model is only used to distinguish whether it is made with or without DEHP). The product materials, manufacturing process and product structure have not changed. Spikes not made with DEHP are marked with Red. The new additions of spike models are: 700204- 1, 700204-2,700205-1, 700205-2, 700206, 700207-1, 700207-2)

This document is an FDA 510(k) summary for a medical device, specifically Single-use Sterile High-pressure Angiographic Syringes and Accessories. It outlines the comparison between the proposed device and a legally marketed predicate device to establish substantial equivalence.

Important Note: This document describes a medical device clearance process for physical hardware (syringes and accessories), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI/MRMC studies, expert consensus on images, ground truth for training/test sets, etc., are not applicable to this type of submission. The 'acceptance criteria' here refer to meeting engineering and biocompatibility standards, and 'proving the device meets the acceptance criteria' is done through non-clinical laboratory testing.

Here's an attempt to answer your questions based on the provided text, while acknowledging that many are not relevant for this device type:

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

The acceptance criteria are primarily defined by adherence to recognized international and ASTM/USP standards for medical devices and the ability to withstand specified pressures. The reported performance confirms compliance with these standards and pressure specifications.

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

The document states "Nonclinical tests were conducted to verify that the proposed device met all design specifications." and refers to compliance with ISO, ASTM, and USP standards. However, specific sample sizes for each non-clinical test are not disclosed in this summary. The data provenance is internal testing conducted by Shenzhen Boon Medical Supply Co., Ltd. (China). This would be prospective, laboratory-based testing of manufactured units, not retrospective analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This is a hardware medical device; no "ground truth" based on expert medical opinion (like for imaging diagnosis) is established for the purpose of these non-clinical tests. The "truth" is whether the device meets engineering specifications and safety standards as measured by laboratory equipment.

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

Not Applicable. As this is a hardware device undergoing non-clinical engineering and biological safety tests, there is no adjudication process involving multiple human reviewers for a "test set" in the context of diagnostic accuracy. Test results are objective measurements against defined standards.

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

Not Applicable. This device is a physical syringe and accessories, not an AI software or system that assists human readers in diagnosis. No MRMC study was performed.

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

Not Applicable. This is not an algorithm or software device.

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

The "ground truth" in this context is defined by international, national, and industry-recognized standards and specifications (e.g., ISO, ASTM, USP) for medical device performance, safety, and biocompatibility. Compliance is determined by objective laboratory measurements and tests against these established benchmarks.

8. The sample size for the training set

Not Applicable. As this is a hardware device, there is no "training set" in the context of machine learning or AI.

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

Not Applicable. There is no training set.

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The Disposable High-pressure Extension Lines is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Disposable High-pressure Extension Lines," which is a medical device. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the text does not include:

• Details about acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Information on sample sizes for test sets (or training sets, for that matter).
• Any mention of data provenance (country of origin, retrospective/prospective).
• Details about experts used for ground truth establishment or their qualifications.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used (expert consensus, pathology, etc.).
• How ground truth for a training set was established.

This document specifically concerns a physical medical device (extension lines for angiographic injectors), not an AI/Software as a Medical Device (SaMD) that would typically involve the types of studies and criteria you've asked about (e.g., performance metrics, ground truth, expert readers, training sets).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.

High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated.

The question asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is a 510(k) Pre-market Notification for a "High Pressure Tubing" device, which describes its comparison to a predicate device and includes information about performance testing, but it does not contain information typically found in a study proving an AI/ML device meets acceptance criteria.

Specifically, the document discusses a medical device that is a physical product (High Pressure Tubing) used in PTCA surgery. It does not mention any AI or machine learning components. Therefore, information regarding "sample sizes used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" is completely absent and not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device by comparing technological characteristics and presenting results of biocompatibility and bench testing.

Based on the provided text, the following information can be extracted regarding the physical device's performance testing, which is analogous to "acceptance criteria" and "device performance" for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the bench testing section):

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

• Not Applicable. The document describes performance and bench testing of a physical medical device, not a software or AI/ML device. Specific sample sizes for each test are not provided, nor is data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective). The tests were conducted to assure reliable design and performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. This information is relevant for AI/ML device validation where human experts establish ground truth. For this physical device, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 80369-7, ISO 80369-20).

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

• Not Applicable. Adjudication methods are used in clinical studies or expert reviews for AI/ML devices to resolve discrepancies in ground truth establishment. This document pertains to physical device testing.

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. MRMC studies are specific to AI/ML devices involving human readers. This document is about a physical high-pressure tubing.

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

• Not Applicable. This concept is only relevant for AI/ML algorithms.

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

• Not Applicable. For this physical device, "ground truth" is adherence to established engineering specifications and international standards for medical device safety and performance.

8. The sample size for the training set:

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

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

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

In summary, the provided document is a 510(k) Pre-market Notification for a conventional (non-AI/ML) medical device. Therefore, most of the questions related to AI/ML device validation are not applicable. The "acceptance criteria" and "device performance" for this specific device are demonstrated through adherence to relevant international standards and successful completion of biocompatibility and bench testing as listed above.

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Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline: they shall be used with US legally marketed angiographic injectors.

The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.

This document is a 510(k) summary for Sterile High-pressure Angiographic Syringes for Single-use. It primarily focuses on demonstrating substantial equivalence to a predicate device (K192657) and does not contain information about a study proving specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for AI/ML technologies.

This type of submission typically demonstrates the device meets a set of performance standards or specifications, rather than a "study that proves the device meets the acceptance criteria" in the way a clinical trial or AI performance study would. The acceptance criteria here relate to physical, chemical, and biological properties, as well as compatibility.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details, are not applicable to this type of device submission.

Here's the available information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests and standards that the device complies with, along with some performance specifications.

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

• The document does not specify sample sizes for the individual non-clinical tests (e.g., number of syringes tested for pressure, number of samples for biocompatibility).
• Data provenance: Not explicitly stated, but the submission is from Shenzhen Boon Medical Supply Co., Ltd. in China, suggesting the tests were likely conducted in China. The submission itself is dated August 13, 2021, and received August 23, 2021, implying these are retrospective test results for device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• This is not applicable. The "ground truth" for this medical device (angiographic syringes) involves meeting engineering specifications and biological safety standards, not diagnostic interpretations that require expert consensus. The compliance is against defined standards (e.g., ISO, ASTM, USP) and internal specifications.

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

• This is not applicable for this type of device. Adjudication methods are typically used in clinical studies for diagnostic accuracy, where disagreements between readers or algorithms need resolution. Here, the tests yield objective pass/fail results against established 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. The device is a physical medical instrument (syringe), not an AI/ML diagnostic or assistive tool.

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 (syringe), not an AI/ML algorithm.

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

• The "ground truth" in this context is defined by international and national standards (e.g., ISO 10993, ASTM F88, USP 41) and the device's own engineering specifications (e.g., maximum pressure resistance, volume, material properties). Compliance is measured against these objective criteria.

8. The sample size for the training set

• This is not applicable. There is no AI/ML component, therefore no "training set."

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

• This is not applicable. There is no AI/ML component, therefore no "training set" ground truth.

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ACIST CVi®1 Contrast Delivery System: The ACIST CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi@1 Syringe Kits are also indicated for single patient use with ACIST CVi® Contrast Delivery Systems. The ACIST CVi@1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

ACIST CVi® Contrast Delivery System: The ACIST CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Kit must be discarded after each patient procedure. The ACIST CVi® Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

The CVi/CVi1 System is designed to aid the physician in the controlled infusion of radiopaque contrast media. Radiographic imaging devices are used in conjunction with the delivery of contrast media to produce angiograms. Operating environments for the CVi/CVi1 System are catheterization and radiological laboratories. The CVi/CVi1 System contains a software-controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume via the ACIST provided consumable kits and a hospital provided angiographic patient catheter. The CVi/CVi1 System is also equipped to synchronize with commercially available X-ray imaging systems. The CVi/CVi1 System is used in interventional cardiology, radiology, and vascular surgical procedures. The CVi/CVi1 System device modification that is the subject of this 510k premarket notification is a material component change to the AngioTouch Hand Controller.

The provided text is a 510(k) summary for the ACIST CVi®1 Contrast Delivery System, focusing on a modification to its AngioTouch Hand Controller. This document primarily addresses the substantial equivalence of the modified device to a predicate device and includes information about the types of testing performed to support this claim, but it does not contain the level of detail typically found in a clinical study report or a publication detailing specific acceptance criteria and detailed performance data for a diagnostic algorithm.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for training sets cannot be extracted from this document.

However, I can extract the following information:

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

The document describes "bench testing" and "biocompatibility testing" to demonstrate that the modified device meets specifications and performs as intended. Specific numerical acceptance criteria and precise performance values are not given, but the summary states the device met specifications.

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

• Sample Size for Test Set: Not specified. The document refers to "bench and biocompatibility testing" without enumerating the number of samples or tests.
• Data Provenance: Not specified. Bench and biocompatibility testing are typically laboratory-based and do not involve patient data provenance in the same way clinical studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software. Ground truth in this context refers to engineering specifications and biological safety standards, not expert consensus on medical images.

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

Not applicable. This is a medical device (contrast delivery system) modification.

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

Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software.

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

Not applicable. This is a medical device (contrast delivery system) modification.

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

For the bench testing, "ground truth" would be established by engineering specifications and industry standards for device performance (e.g., burst pressure limits, flow rate accuracy). For biocompatibility, "ground truth" is established by recognized standards for biological safety (e.g., ISO 10993 series). The document states the modified device "meets specification and performs as intended," implying conformity to these established engineering and biological safety standards.

8. The sample size for the training set

Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software that requires a training set.

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

Not applicable. This is a medical device (contrast delivery system) modification.

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The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.

The proposed devices are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.

The provided document is a 510(k) premarket notification for a medical device: "Sterile High-pressure Angiographic Syringes for Single-use". This type of submission focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.

As such, the document does not describe a study to prove the device meets acceptance criteria in the way you've outlined for an AI-powered diagnostic device. Instead, it details non-clinical tests to show the proposed device performs comparably to the predicate and meets relevant engineering standards.

Therefore, many of your requested points regarding Acceptance Criteria and Study Proof (especially related to AI, MRMC, expert consensus, and ground truth establishment) are not applicable to this 510(k) submission for a non-AI medical device.

However, I can extract the relevant information from the document regarding the "acceptance criteria" (in the sense of standards compliance and comparative performance) and the "study" (non-clinical tests) that proves these criteria are met.

Here's a breakdown based on the provided document:

Device: Sterile High-pressure Angiographic Syringes for Single-use

Device Type: Non-AI Medical Device (Angiographic Syringes)

Study Purpose: To demonstrate Substantial Equivalence (SE) to a predicate device (Shenzhen BaoAn Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use, K151960) through non-clinical testing and comparison.

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

For a non-AI device like this syringe, "acceptance criteria" primarily refer to adherence to recognized international standards and demonstration of comparable performance to a predicate device. "Reported device performance" is the outcome of non-clinical tests demonstrating compliance.

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

• Sample Size: The document does not explicitly state the number of units/samples used for each non-clinical test (e.g., how many syringes were tested for seal strength, or how many batches for endotoxin). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The specific number of test replicates/samples would typically be detailed in the full test reports, which are not part of this summary document.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed to verify compliance with standards. The company "Youwo (Guangzhou) Medical Device Co., Ltd." is based in Guangzhou, P.R. China, implying the testing was conducted in China, likely at their own facilities or certified labs in China. The data is entirely lab-generated, not from human subjects. The nature of the testing is prospective, in the sense that the tests were performed specifically for this submission on new device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a non-AI, non-diagnostic medical device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance of these syringes is defined by the objective pass/fail criteria of the recognized engineering and biocompatibility standards (e.g., is the seal strong enough? Is there pyrogen presence?). Compliance is measured by laboratory equipment and established protocols, not expert human review of an image or signal.

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

• Not Applicable. As per point 3, there's no human diagnostic interpretation to adjudicate. Test results are objective measurements against pre-defined thresholds from standards.

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

• Not Applicable. This device is not an AI diagnostic tool, nor is it intended to assist human readers in interpreting medical cases. No MRMC study was conducted.

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

• Not Applicable. This is not an algorithm or AI device. Standalone performance refers to the device's ability to meet its specifications independently, which is what the non-clinical tests implicitly demonstrate (e.g., a syringe's seal strength is measured independently of human operation).

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

• Standards-Defined Ground Truth: The "ground truth" here is the adherence to internationally recognized performance and safety standards (e.g., ISO, ASTM, USP). The device is "true" if it passes the specified tests according to the criteria defined within those standards. For example, a "true" biocompatible device produces no cytotoxicity according to ISO 10993-5. This is determined by laboratory measurements and chemical/biological assays, not clinical outcomes or expert diagnostician consensus.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device. There is no training set.

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

• Not Applicable. This is not an AI/machine learning device. No ground truth for a training set was established.

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Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube and spike.

The provided text is a 510(k) Summary for a medical device (Sterile High-pressure Angiographic Syringes for Single-use). It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in a clinical setting.

Therefore, I cannot provide information regarding:

• Acceptance Criteria and Reported Device Performance for clinical outcomes: The document focuses on performance specifications (e.g., pressure, sterility, biocompatibility) of the device components, not clinical performance metrics or specific acceptance criteria for a clinical study.
• Sample size for the test set and data provenance: No clinical test set is described. The "test set" here refers to samples used for non-clinical engineering and biological tests.
• Number of experts and qualifications, and adjudication method: These pertain to clinical studies with a ground truth established by experts, which is not applicable here.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This is a type of clinical study not performed or referenced in this document.
• Effect size of human readers with/without AI assistance: This is irrelevant as the device is a syringe and connection tube, not an AI-assisted diagnostic tool.
• Standalone (algorithm only without human-in-the-loop performance): This is also irrelevant for this type of medical device.
• Type of ground truth used: Ground truth, typically defined by expert consensus or pathology in a clinical context, is not applicable here. The "ground truth" for these non-clinical tests is adherence to established engineering and biological standards.
• Sample size for the training set and how the ground truth for the training set was established: These concepts are related to machine learning and AI, which are not relevant to the described device.

What the document does provide in relation to "acceptance criteria" and "study that proves the device meets the acceptance criteria" (within the scope of a 510(k) for a physical medical device):

The document details a series of non-clinical tests performed to demonstrate that the proposed device meets established performance standards and is substantially equivalent to a predicate device. These standards effectively act as the "acceptance criteria" for the device's design and manufacturing.

Here's a summary of the non-clinical acceptance criteria (standards/tests) and the reported performance:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)

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

• The document does not specify the exact sample sizes (number of units) used for each non-clinical test. It generally states that "Non clinical tests were conducted."
• The data provenance is from non-clinical laboratory testing performed by the manufacturer (Shenzhen Boon Medical Supply Co., Ltd) in China, as per the sponsor identification. These are not human clinical trials.

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 this context refers to established engineering and biological standards (e.g., ISO, ASTM, USP), not expert clinical adjudication. Compliance with these standards is determined by trained technicians/engineers through validated testing methods.

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

• Not applicable. This concept relates to multi-expert clinical review, which is not relevant for non-clinical device testing verifying adherence to standards.

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

• No. This is not relevant to a sterile syringe product.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" for proving it meets "acceptance criteria" is adherence to recognized international and national standards for medical device performance, biocompatibility, and sterility (e.g., ISO 7886, ISO 594, ISO 10993, ASTM F88, USP monographs).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

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