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The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The Oral/Enteral Syringe with ENFit connector is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The Oral/Enteral Syringe with ENFit connector consists of plunger, gasket/piston, barrel with ENFit connector, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The proposed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) premarket notification for an Oral/Enteral Syringe with ENFit connector, seeking substantial equivalence to a predicate device. As such, it does not describe a study to prove a device meets acceptance criteria in the way a clinical trial or performance study for a novel diagnostic algorithm might. Instead, it demonstrates substantial equivalence by showing that the device meets relevant performance standards and has similar technological characteristics to a predicate device.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable in the context of this 510(k) submission for a non-active medical device like a syringe.

However, I can extract the acceptance criteria where applicable (i.e., performance standards and biocompatibility) and report the device's performance against those standards as described in the document.

Acceptance Criteria and Device Performance (Oral/Enteral Syringe with ENFit connector)

Device Under Review: Oral/Enteral Syringe with ENFit connector (K222772)
Predicate Device: Oral/Enteral Syringe with ENFit connector (K211025)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but standard test methods were followed. The number of devices required for each standard (e.g., ISO 7886-1, ISO 80369-3) would dictate the sample sizes.
• Data Provenance: The tests are non-clinical (bench testing, material testing, biocompatibility testing) performed on the manufactured device. The location of testing labs is not specified, but the applicant is based in China. The data is prospective for the purpose of this submission (i.e., new tests performed on the specific device for this submission).

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

• Not Applicable. This is a non-clinical device submission. "Ground truth" in the diagnostic/AI sense is not relevant. Performance is measured against established international and harmonized standards.

4. Adjudication method for the test set:

• Not Applicable. This refers to clinical assessments or expert review, which is not part of this type of submission. Testing involves laboratory measurements against predefined criteria in standards.

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

• Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

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

• Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

7. The type of ground truth used:

• Not Applicable. For this type of device, performance is evaluated against objective, measurable criteria defined in international scientific and engineering standards (e.g., ISO, ASTM). There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic product.

8. The sample size for the training set:

• Not Applicable. This is a non-AI device submission; there is no "training set."

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

• Not Applicable. This is a non-AI device submission; there is no "training set" or ground truth for it.

Summary of Study (Based on Submitted Information):

The "study" in this context is a collection of non-clinical performance evaluations and testing conducted to demonstrate that the Anhui Tiankang Medical Technology Co., Ltd. Oral/Enteral Syringe with ENFit connector is substantially equivalent to its predicate device. This involves:

• Biocompatibility Testing: Evaluating the device's materials for cytotoxicity, irritation, and sensitization according to ISO 10993 series. The device reported "No Cytotoxicity; No Irritation; No Sensitization."
• Sterilization Validation: Confirming the Ethylene Oxide (EO) sterilization process meets ISO 11135 standards and an SAL of 10-6, along with EO and ECH residue testing per ISO 10993-7. The device was found to comply.
• Shelf Life Determination: Performing accelerated aging tests according to ASTM F1980-16 to support a 3-year shelf life.
• Package Integrity Testing: Conducting tests like seal strength (ASTM F88/F88M-15), blue dye penetration (ASTM F1929-2015), and visual inspection (ASTM F1886/F1886M-16) to ensure packaging maintains sterility. All packaging was deemed acceptable.
• Product Performance Testing: Evaluating the syringe against specific functional standards:
  • Dose accuracy according to ISO 7886-1:2017.
  • Enteral connector compatibility and performance according to ISO 80369-3:2016.
  • General connector requirements and common test methods from ISO 80369-1:2018 and ISO 80369-20:2015.
  • Material properties referenced by ASTM D638-22 and ASTM D790-17.

The submission concludes that the non-clinical testing demonstrates the device's safety, effectiveness, and performance are comparable to the legally marketed predicate device, thereby establishing substantial equivalence. No clinical studies were included or deemed necessary for this type of device.

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The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) Summary for the Oral/Enteral Syringe with ENFit connector (K211025). It does not contain information about a study proving the device meets acceptance criteria in the manner you describe for AI/imaging devices. Instead, it demonstrates substantial equivalence to a predicate device (K161039) through non-clinical testing.

Here's an analysis of the information provided in the context of your questions, explaining why certain sections are not applicable:

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

The document provides a list of standards the device complies with, which implicitly serve as acceptance criteria for different aspects of the device's performance. It also states that "dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity." This is a key performance metric and a stated acceptance criterion.

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 mentions "non clinical tests were conducted," but does not specify the sample sizes for these tests for each standard or the dose accuracy testing. It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as these types of details are typically associated with clinical studies involving patient data, not non-clinical device testing.

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 question is not applicable to this type of device submission. The "ground truth" concept, especially involving expert consensus and specific qualifications of medical professionals, is relevant for AI/imaging devices interpreting medical images or data. For this physical medical device (an enteral syringe), performance is assessed through objective engineering and biological tests against established international standards, not against expert human interpretations of data.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where multiple experts evaluate ambiguous cases. For non-clinical tests on a physical device, the results are typically objectively measured and do not require expert adjudication in this manner.

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 question is not applicable. MRMC studies are specifically designed for assessing the performance of diagnostic devices, particularly AI-powered ones, and their impact on human reader performance. This submission is for a physical medical device (a syringe), not a diagnostic AI tool.

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

This question is not applicable. This refers to the standalone performance of an algorithm. The device here is a physical syringe, not an algorithm.

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

For this device, the "ground truth" is established by the requirements of the referenced international standards (e.g., ISO for sterility, biocompatibility, connector features, and ASTM for material properties) and specific performance specifications (e.g., dose accuracy ±10%). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for proving the performance of a syringe.

8. The sample size for the training set

This question is not applicable. This refers to the training data for an AI algorithm. This submission is for a physical medical device.

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

This question is not applicable. This refers to establishing ground truth for AI model training. This submission is for a physical medical device.

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The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The enteral feeding syringe consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male tapered connector. There are 2 types of the syringe: Side connector tapered syringe and central connector tapered syringe. The sizes of the central connector tapered syringe range from 0.5ml to 3ml; and side connector tapered syringe range from 6ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The provided text is a 510(k) Summary for an Oral/Enteral Syringe, which is a medical device for dispensing and transferring fluids. It outlines the regulatory process for clearance and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Crucially, this document describes physical, mechanical, chemical, and biocompatibility testing of a physical medical device (a syringe), not a software or AI-based device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to software performance (e.g., sensitivity, specificity, F1 score for an AI model) are not relevant here.

The document discusses performance purely in terms of the physical characteristics of the syringe.

However, I can extract the information related to the physical device's "acceptance criteria" and the "study" (non-clinical tests) that proves it, as per the format you requested, but adapted for a physical device:

Acceptance Criteria and Study Proving Device Meets Criteria (for a Physical Medical Device)

The device in question is an Oral/Enteral Syringe. The acceptance criteria and the studies (non-clinical tests) proving the device meets these criteria are related to its physical properties, material safety, and functionality as a fluid delivery device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample sizes" (i.e., number of syringes tested) for each non-clinical test. It broadly states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

• Data Provenance: The tests were conducted internally by or for Ningbo Tianyi Medical Appliance Co., Ltd. The data is from prospective non-clinical laboratory testing of the manufactured device. The country of origin of the data would be China, where the manufacturer is located.

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

This question is not applicable as the "ground truth" for a physical device like a syringe is established by objective engineering and laboratory measurements against internationally recognized standards (e.g., ISO, ASTM). There is no "expert consensus" in the sense of medical image interpretation for ground truth.

The "experts" involved would be qualified laboratory technicians and engineers with expertise in medical device testing and quality control.

4. Adjudication Method for the Test Set

Not applicable. As described above, the verification involves objective measurements against established technical standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document pertains to a physical medical device.

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

Not applicable. This is a physical device, not an algorithm. The "standalone performance" is equivalent to the results of the non-clinical tests demonstrating compliance with physical, mechanical, and biocompatibility standards.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established international and national standards (e.g., ISO 7886-1, ISO 80369 series, ISO 10993 series, ASTM F88/F88M, ASTM F1929) for medical device design, manufacturing, and safety. This involves objective measurements and assessments rather than clinical outcomes or expert consensus in an interpretative medical sense.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical device.

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The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

The proposed device is a disposable enteral feeding syringe provided two models, including Type A and Type B, the main difference is the piston of Type A is rubber stopper made of isoprene rubber, and the piston of Type B is rubber pad made of silicone rubber. The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml. The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.

This document is a 510(k) premarket notification for an Oral/Enteral Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study of an AI/ML powered device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and study proving an AI/ML device meets those criteria.

The document states:

• "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• "No clinical study is included in this submission."

Therefore, I cannot extract the requested information as it pertains to a medical device (syringe), not an AI/ML powered device.

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Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile):

The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile):

The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 12 mL to 60 mL nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip that has the additional low dose tip design feature, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 1 mL to 6 mL nominal capacity. The integral syringe tip is a female ENFit connector with the additional low dose tip design feature which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

Reusable Standard ENFit Syringes (12 mL to 60 mL) and reusable Low Dose Tip ENFit Svringes (1 mL to 6 mL) are supplied non-sterile and are intended for single patient use. They are provided in varying colors and sizes ranging from 1 mL to 60 mL nominal capacity.

The provided text describes a medical device, NeoMed Oral/Enteral Syringes with ENFit® connector, and its substantial equivalence to a predicate device. However, the document does not contain information typically found in studies that prove a device meets acceptance criteria for an AI/ML product. The questions raised in the prompt are more relevant to AI/ML device performance evaluation than to the type of medical device described (syringes).

Therefore, I cannot provide a direct answer to the acceptance criteria and study details for an AI/ML device based on the given input, as the input focuses on a physical medical device (syringes) and its substantial equivalence determination.

The document does list "PERFORMANCE DATA (BENCH)" for the syringes, which includes various tests to ensure the physical device's functionality, safety, and compliance with standards. These are benchmarks for the syringes, not for an AI/ML algorithm.

If the prompt were intended for a different type of medical device where AI/ML is involved, the information required would typically be found in clinical study reports, performance evaluation sections, or specific FDA guidance documents for AI/ML-based medical devices.

Summary of what can be extracted from the provided text regarding device performance (for the syringes, not an AI/ML device):

The device is NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL).

The document details various performance tests (bench) conducted to demonstrate the device's substantial equivalence to a predicate device (K161039). These tests assess the physical and functional attributes of the syringes.

Here's a breakdown of the performance data provided for the syringes:

• Finished Device Testing:

  • Risk Analysis (design, use, and process FMEA in accordance with ISO 14971:2007)
  • Human Factors and Usability Validation
  • Biocompatibility (ISO 10993-5: Cytotoxicity, ISO 10993-10: Irritation and sensitization, ISO 10993-11: Acute Toxicity)
  • Chemical Testing (Extractables and Leachables)
  • Reusability (Cleaning Instructions Validation, Use Cycle Parameters Study)
  • Finished Device Verification Testing (Critical Dimension verification, Ink Adhesion, ISO 7886)
  • Capacity Tolerance
  • Graduated Scale
  • Piston Fit in Barrel
  • Air and Liquid Leakage Testing
  • Direct Oral Administration Dosing Accuracy Testing

• Syringe Tip (ISO 80369-3 (ENFit) connector) Testing:

  • Enteral Connector Misconnection Assessment
  • Human Factors Validation Study (Standard ENFit)
  • Dimensional verification to ISO 80369-3
  • Liquid leakage testing
  • Resistance to stress cracking
  • Resistance to separation from axial load
  • Resistance to separation from unscrewing
  • Resistance to overriding
  • Disconnection by unscrewing

• Syringe Tip (ISO 80369-3 (ENFit) connector with Low Dose Tip Design Feature) Testing:

  • Low Dose Tip Misconnection Risk Management Report
  • Usability Study for Low Dose Syringe Tip Design Feature
  • Low Dose Tip Oral/Enteral Syringe Design Dosing Accuracy Testing
  • Dimensional verification to ISO 80369-3
  • Liquid leakage testing
  • Resistance to stress cracking
  • Resistance to separation from axial load
  • Resistance to separation from unscrewing
  • Resistance to overriding
  • Disconnection by unscrewing

Regarding the specific questions in the prompt (relevant to an AI/ML device, not these syringes):

1. A table of acceptance criteria and the reported device performance: This information is not provided in a format relevant to AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The performance data listed are for the physical properties and functionality of syringes.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device. The "test set" here refers to the samples of syringes subjected to various bench tests, not a dataset for an AI/ML model.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for AI/ML refers to expert labels or pathology results. For these syringes, "ground truth" would be engineering specifications and international standards.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for assessing human performance with/without AI assistance.
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 these syringes, the "ground truth" for the tests would be established by engineering specifications, validated test methods, and adherence to international standards like ISO 14971, ISO 10993, ISO 7886, and ISO 80369-3.
8. The sample size for the training set: Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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The subject device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) are basically enteral syringes that can also be used for oral uses. There are two different types of models of the syringes, which are Type A and Type B. The Type A syringes of a polypropylene barrel and plunger rod and a synthetic rubber gasket stopper manufactured from polyisoprene. The Type B syringes consist of a polypropylene barrel and plunger rod and a silicone O-ring. The 10 to 60 mL syringes come with the standard female ENFit connector and the 1 to 5 mL syringes come with a female ENFit connector incorporating a low dose tip design.

The provided text focuses on establishing substantial equivalence for an Oral/Enteral Syringe, primarily through comparison to a predicate device and adherence to recognized standards. It does not contain information about an AI/ML powered medical device, or the kind of acceptance criteria and study designs that would be typical for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics like sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, as this information is not present in the provided document for this particular medical device.

The document discusses non-clinical tests performed to ensure the device's effectiveness and safety, primarily focusing on:

• Biocompatibility: Adherence to ISO 10993 series standards (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity).
• Performance safety and effectiveness (according to ISO 7886-1): Cleanliness, lubricant, limits of extractable metals, limits for acidity/alkalinity, tolerance on graduated capacity, graduated scale, dead space, barrel configuration, nozzle design verification, piston/plunger assembly, freedom from air and liquid leakage, force to operate the piston.
• Performance safety and effectiveness (according to ISO 80369-3 for connectors): Fluid leakage, stress cracking, resistance to separation from axial load, resistance to unscrewing, resistance to overriding, disconnection by unscrewing.
• Additional Performance tests: Dimensional verification (to ISO 80369-3, low dose tips, syringes), risk management report, dosing accuracy testing (for low dose tips and oral administration).

The conclusion states that the "subject device will be as safe and effective for usage as the listed predicate device," based on these non-clinical tests and the comparison of technological characteristics. No clinical tests were performed for this submission.

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The Oral/Enteral Syringes is intended for the delivery of liquid medication, formula, and breast milk.

The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.

The provided text describes a 510(k) premarket notification for "Oral/Enteral Syringes." However, it is a submission for a medical device (syringes), not an AI/ML powered device. As such, the information you requested regarding acceptance criteria and studies that apply to AI/ML powered devices, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through design verification tests related to the physical and functional properties of the syringes.

Here's the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

2. Sample size used for the test set and the data provenance: Not applicable (this is a physical device, not an AI/ML model evaluated on a test set of data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical properties and functional performance as described by engineering and regulatory standards, not expert consensus on data interpretation.

8. The sample size for the training set: Not applicable.

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

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