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The Safety Sliding Blood Collection Set is intention into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

Components of the subject device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap.

The subject device has three configurations: with Holder, with Holder, without Male Adapter. Each configuration has all of the (1) - (6) components mentioned above. The difference between the three configurations is that they have only one or more of the (7) – (12) components mentioned above. The proposed device is available various needle size and flexible tube length. The range of needle size is from 25G (0.5mm) to 20G (0.9mm). The range of flexible tube length is from 10cm (4") to 30cm (12").

The subject device has sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature.

The subject device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) 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.

No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

The provided document describes the Jiangsu Caina Medical Co., Ltd.'s "Safety Sliding Blood Collection Set" (K232781) and its substantial equivalence to a predicate device (K980414), but it does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document primarily focuses on:

• Regulatory Clearance: Announcing FDA clearance (510(k)) based on substantial equivalence.
• Indications for Use: Describing the intended purpose of the device.
• Device Description: Outlining the components and configurations.
• Comparison to Predicate Device: Detailing similarities and differences between the subject device and the predicate.
• Non-Clinical Testing: Listing the international standards and specific tests conducted (e.g., biocompatibility, sterility, seal integrity, sharps injury protection) to support the substantial equivalence claim.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving their fulfillment based on this document.

The document explicitly states:

• 10. Clinical Test Conclusion: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device." This indicates that the regulatory clearance was based on non-clinical data and comparison to an existing device, rather than a clinical trial with specific performance acceptance criteria.

The "Non-Clinical Testing" section lists various tests performed (e.g., ISO, ASTM standards, extraction force, simulated clinical study for safety feature, sharps injury protection testing). These tests would have their own internal pass/fail criteria as defined by the respective standards or the manufacturer's internal specifications. However, these specific criteria and the detailed results demonstrating achievement are not provided in this publicly available 510(k) summary.

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The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.

To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting.

The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years.

No DEHP, BPA and Natural Rubber Latex are added in the device.

The provided text is a 510(k) summary for the ENFit Adaptor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/ML device from this document.

The document discusses non-clinical tests to verify design specifications and compliance with various ISO standards for mechanical performance, biocompatibility, sterilization, shipping, and shelf-life of the physical adaptor. These tests are performed to demonstrate that the device itself is safe and effective as a physical connector, not as an AI-powered diagnostic or therapeutic tool.

For instance, the document mentions:

• Performance tests: Fluid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing, Connector Incompatibility Test, Materials Used for Small-bore Connectors, Dimensional analysis, Compatibility and Usability Test.
• Biocompatibility tests: Cytotoxicity, Irritation, Skin Sensitization.
• Sterilization, Shipping and Shelf-Life tests: Ethylene oxide sterilization residuals, seal leak detection, seal strength, seal integrity, Bacterial Endotoxins Test.

These are all physical and chemical property tests for a medical device connector, not performance metrics of an AI/ML algorithm.

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Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The proposed device, Pen Needle, is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It is provided sterile, single use. The proposed device consists of four components, which are 1) Needle Container 2) Needle Shield 3) Needle Tube and 4) Needle Hub. Needle Container, together with Sealed Paper can forming the unit packaging of Pen Needle, that maintains the sterility of Pen Needle Hub can be connected screwed onto the pen injectors.

The provided document is a 510(k) premarket notification for a medical device (Pen Needle) and focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML medical device submission. Therefore, the document does not contain information typically found in an AI/ML medical device acceptance criteria and study section, such as:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes used for a test set or data provenance for an AI/ML algorithm.
• Number of experts or qualifications of experts used for AI ground truth.
• Adjudication methods for AI test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI performance.
• Type of ground truth used for AI/ML.
• Sample size or ground truth establishment for an AI/ML training set.

The document discusses non-clinical tests performed to verify the Pen Needle met design specifications and complied with ISO standards, focusing on manufacturing quality, sterility, and biocompatibility rather than an AI algorithm's performance.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Safety Push Button Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood specimens. When used without the male adapter, the device allows the clinician to obtain blood sampling from the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician. It aids in the prevention of accidental needle stick through the use of an active safety feature. The device is a sterile, multiple sample, single-use.

The proposed device consists of these components: (1) Needle, (3) Spring, (4) Butterfly wings, (5) Hub, (6) Safety sheath, (7) Flexible tube, (8) Female luer, (9) Male luer hub, (10) Puncture needle, (11) Rubber sleeve, (12) Puncture needle protect cover or holder, (13) Safety push button protect cover. The proposed device have three configurations: With holder, With holder, Without male adapter. For without male adapter, there is a a protective cap to cover female luer. The proposed device is available various needle size and tube length. The range of needle size is from 25G(0.5mm). The range of tube length is from 10cm(4") to 30cm(12"). The proposed device have sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) 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. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

The provided document, a 510(k) Summary for the Safety Push Button Blood Collection Set, is a premarket notification to the FDA. It aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific, independently defined acceptance criteria through a clinical study.

Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies, are not applicable or found in this type of submission. This document focuses on demonstrating equivalence through non-clinical testing and comparison of technical characteristics.

Here's an analysis of the provided information in relation to your request:

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

• Not Applicable in this format. This document is a 510(k) submission for substantial equivalence, not a clinical trial report with defined acceptance criteria for a new performance claim. The "acceptance criteria" are implied by the performance standards the device was tested against and found to comply with, as detailed in Section 8 "Non-Clinical Test Conclusion."
• Implied Performance: The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies applicable parts of the following standards." This implies the device performed within the specifications of these standards.
• Specific Compliance Examples (from Section 8):
  • Biological Safety: Complied with ISO 10993-7 (Ethylene Oxide Sterilization Residuals), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), USP (Pyrogen Test), ASTM F756-17 (Hemolytic Properties), USP (Bacterial Endotoxins Test).
  • Packaging and Sterility: Complied with ASTM F1929-15 (detecting seal leaks), ASTM F88/F88M-21 (seal strength), ASTM F1886/F1886M-16 (integrity of seals by visual inspection), ISO 11607 and ISTA 3A (shelf-life validation for sterility maintenance over 3 years).
  • Device Performance: Complied with ISO 80369-7 (small-bore connectors), ISO 8536-4 (infusion sets), ISO 9626 (stainless steel needle tubing), ISO 7864 (sterile hypodermic needles).
  • Safety Feature: "Simulated Clinical Study for safety feature" and "Sharps injury protection testing in accordance with ISO 23908" were performed. The document states it aids in the prevention of accidental needle sticks.

A table summarizing this would look like:

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: Not explicitly stated for each test. The document refers to "non-clinical tests" and "verification or testing." For a 510(k) submission of a physical device like this, sample sizes would typically be determined by the specific ISO/ASTM standards being followed for each test (e.g., a certain number of units for sterility, strength, or material compatibility tests). These are typically in-house lab tests, not human subject studies.
• Data Provenance: The tests were conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd., based in China. The tests are non-clinical, likely in-house laboratory testing following international standards. No human data is involved. It's prospective testing of the manufactured device.

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

• Not Applicable. As a non-clinical device where substantial equivalence is demonstrated through engineering and material testing, there is no "ground truth" established by human experts in the way that would apply to an AI/imaging device (e.g., radiology reads). The "ground truth" is defined by the physical, chemical, and biological properties measured against established industry standards (ISO, ASTM, USP).

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

• Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or expert review processes for AI. This is a non-clinical testing submission.

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

• No. This is a physical medical device (blood collection set), not an AI-powered diagnostic or imaging device. MRMC studies are not relevant to its evaluation.

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.

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

• Defined by International Standards/Lab Results. For this device, "ground truth" is implicitly established by the quantitative and qualitative results of highly standardized laboratory tests against predefined limits set by ISO, ASTM, and USP standards. For example:
  • Sterility: Absence of microbial growth, reaching a SAL of 10^-6.
  • Biocompatibility: No cytotoxicity, sensitization, irritation, pyrogenicity, or hemolysis as per standard tests.
  • Physical Integrity: Meeting specified tensile strength, leak detection, and dimensional requirements.
  • Sharps Injury Protection: Successful activation of the safety feature and prevention of needle sticks as per ISO 23908.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device. There is no "training set" in this context. The company manufactures these devices, and testing is done on production samples.

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

• Not Applicable. See point 8.

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The Vented Vial Transfer Pin is intended for the transfer and mixing of drugs contained in a vial.

The proposed device consists of five components: (1) Protective cap, (2) Piercing spike, (3) Filter medium, (4) Filter shell, (5) Luer connector cap. The piercing spike contains the dual lumen channel for liquid and air. A 0.2um hydrophobic air filter medium is assembled to the end of air channel. This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/released air through filter medium. There is a female Luer lock connector in the end of liquid channel, it can be attached a device with a male Luer connector (e.g., standard syringe). The proposed device is available 2 specifications according to design, with security clip and without security clip. The Vented Vial Transfer Pin with Security Clip designed which can be fixed to a 13mm drug vial to prevent accidental separation. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

This document is a 510(k) Summary for a medical device called the "Vented Vial Transfer Pin." It mostly focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for the new device as an AI or diagnostic tool.

However, it does list several non-clinical tests that were performed to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests, along with comments on the differences between the proposed and predicate devices, indirectly describe acceptance criteria and how the device met them.

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

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

The document does not explicitly present a table of acceptance criteria alongside reported performance in the general sense of a diagnostic or AI device. Instead, it lists standards with which non-clinical tests complied and states that the proposed device "met all design specifications" and "complies with the following standards." The comments section addresses differences between the proposed and predicate device and assures that these differences do not affect substantial equivalence on safety and effectiveness.

Here's an interpretation based on the provided text, focusing on the non-clinical tests:

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 relates to a physical medical device (Vented Vial Transfer Pin), not an AI/diagnostic software. Therefore, there is no "test set" in the context of data for an algorithm. The non-clinical tests would have involved physical samples of the device. The document does not specify the number of units tested for each non-clinical test.

Data provenance is not applicable here as it refers to typical AI/diagnostic data (e.g., patient images, medical records).

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 device is a physical medical device, not an AI or diagnostic tool that requires ground truth established by medical experts for performance evaluation. The "ground truth" for this device's performance would be derived from the physical and chemical properties and test outcomes according to the cited standards.

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

Not applicable. This is not an AI/diagnostic software study involving human readers or adjudication of results.

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

Not applicable. This is not an AI 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.

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

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

• Compliance with international and national standards (e.g., ISO, ASTM, USP) for materials, sterility, packaging, and functional performance.
• Material properties and test results from laboratory analyses (e.g., cytotoxicity, hemolytic properties, tensile strength).
• Physical measurements and functional tests directly assessing the device's ability to perform its intended function (e.g., flow rate, filter bursting pressure).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm.

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

Not applicable. This is a physical device, not an AI/ML algorithm.

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Single use O-ring gasket syringe 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 settings by users ranging from clinicians to laypersons in all age groups.

Reusable O-ring gasket syringe with ENFit connector-(provided non-sterile):
The device is indicated for use as a dispenser, a measuring 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.

The proposed device is manual feeding syringe, used as a dispenser, a measuring device, and a fluid transfer device. And it is used to deliver fluids into the body orally or enterally in clinical and non-clinical settings.

There are 2 types of connector for proposed device: Low dose tip ENFit connector(1ml to 6ml) and Standard ENFit connector(12ml to 60ml). The proposed device is standard piston syringe consisting of a plastic hollow barrel with female ENFit connector of ISO 80369-3, plunger, 0-ring piston, Connector of 1ml and 3ml syringe situated centrally, connector of other syringe situated eccentrically. All connectors are compatible only with enteral access or accessories having male ENFit connector of ISO 80369-3. The proposed syringes are available in transparent barrel and amber barrel.

The proposed device is provided sterile or non-sterile, single use or reusable. The sterile device is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life. The reusable device is for single patient use only.

The proposed device is made with polypropylene and Silica gel. No DEHP, BPA and Natural Rubber Latex are added in the proposed device. The proposed device also has an optional syringe tip cap.

The provided document is a 510(k) Premarket Notification for a medical device (O-ring gasket syringe with ENFit connector). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving a device meets specific acceptance criteria through a large-scale clinical study or AI performance evaluation.

Therefore, the information typically requested in your prompt regarding AI/algorithm performance, ground truth establishment for training and test sets, multi-reader multi-case (MRMC) studies, expert opinions, and sample sizes for AI model development is not present in this document.

The document demonstrates compliance with performance standards for a physical medical device. Here's what can be extracted and inferred based on the document's content:

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

The document doesn't present a table of "acceptance criteria" in a quantitative sense as might be found for algorithm performance (e.g., minimum accuracy). Instead, it lists the standards the device was tested against and states that the test results "demonstrated that the proposed device complies with the following standards." Compliance with these standards is the acceptance criterion for a physical device in this context.

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

• Sample Size: Not explicitly stated for each test. These would be determined by the specific requirements of each ISO/ASTM standard (e.g., how many units are tested for seal integrity or biocompatibility).
• Data Provenance: The tests were "Non-clinical tests" conducted to verify compliance with international standards. The country of origin for the testing itself is not specified, but the applicant (Jiangsu Caina Medical Co., Ltd.) is from China. These are laboratory-based compliance tests, not data collected from human subjects.
• Retrospective or Prospective: Not applicable, as these are technical performance tests, not clinical data collection.

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

• This is not applicable. The "ground truth" for the device's physical performance is established by the definitions and methodologies within the cited international standards (ISO, ASTM, USP-NF). The tests are designed to objectively measure properties and assess compliance according to these universally accepted procedures, not through expert consensus in the way a medical image diagnosis might be.

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

• Not applicable. Adjudication methods are typically used for subjective assessments (like medical image interpretation). For compliance testing against engineering and biological standards, the results are typically quantitative measurements that either meet or fail a predefined specification.

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

• No. This type of study (MRMC, human readers, AI assistance) is relevant for AI-powered diagnostic devices. The device in question is a physical syringe, not an AI diagnostic tool.
• The document explicitly states: "No clinical study is included in this submission."

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

• No. This is not an AI algorithm.

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

• For this device, the "ground truth" for proving performance is adherence to established international and national engineering and biological standards. This involves:
  • Validated test methods: e.g., the specific procedures for pyrogen testing (USP-NF ), seal integrity (ASTM F88/F88M-21), or material biocompatibility (ISO 10993 series).
  • Defined acceptance limits/specifications: e.g., allowable residuals of ethylene oxide, specified ranges for dosing accuracy, or criteria for passing cytotoxicity tests.

8. The sample size for the training set:

• Not applicable. This is not an AI model requiring a training set.

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

• Not applicable.

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The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

The Pump Alignment Syringe is available in various specifications, including 3ml, 5ml, 10ml, 30ml and 60ml. The proposed device consists of three components: (1) plunger, (2) piston, (3) barrel. The connector of barrel have two types of luer-lock and luer-slip. The proposed device is provided sterile. The product 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 five years.

The provided text describes the submission of a 510(k) premarket notification for a Pump Alignment Syringe (K220184) and its comparison to a predicate device (K980987). However, it does not contain information regarding traditional acceptance criteria, performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) typically associated with AI/ML-based medical device studies.

The document focuses on demonstrating substantial equivalence based on non-clinical tests and a comparison of technical characteristics. The "performance testing" mentioned refers to compliance with ISO standards for syringes, not a study evaluating specific performance metrics against acceptance criteria in the context of AI/ML.

Here's an analysis based on the information provided in the document:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of AI/ML. Instead, it lists standards that the device conforms to. For the purpose of this request, I will interpret "reported device performance" as the device's conformity to these standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. These tests assessed biocompatibility, packaging integrity, sterility, and physical/functional performance according to the listed standards.

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

This information is not provided in the document. The document primarily reports adherence to engineering and biological safety standards, not a clinical or AI/ML performance study involving test sets 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):

This information is not applicable/not provided. The device is a physical medical device (syringe), and its performance evaluation involves compliance with established engineering and biological standards, not interpretation by experts to establish a "ground truth" on a test set (as would be typical for an AI/ML diagnostic or prognostic device).

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

This information is not applicable/not provided. Adjudication methods are relevant for studies where expert disagreement needs a resolution mechanism, which is not the case for the type of testing described (compliance with physical and biological 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human interpretation, which is not the function of this Pump Alignment Syringe.

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

No, a standalone algorithm-only performance assessment was not done. The device is a physical syringe and does not involve an algorithm.

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

The "ground truth" for this device is its adherence to established international and national standards (e.g., ISO, ASTM, USP) for materials, sterility, package integrity, and functional performance. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of a clinical diagnostic study.

8. The sample size for the training set:

This information is not applicable/not provided. The device is not an AI/ML product developed using training data. Its development involves engineering design and manufacturing processes, followed by testing against standards.

9. How the ground truth for the training set was established:
This information is not applicable/not provided as there is no training set for this type of device.

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The Pre-filled Syringe with Saline is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

Not Found

This document is an FDA 510(k) clearance letter for a "Pre-filled Syringe with Saline." It does not contain any information about acceptance criteria or a study proving device performance as would be relevant for an AI/ML or diagnostic device.

The provided text deals with:

• The FDA's determination of substantial equivalence for a medical device (a pre-filled saline syringe).
• Regulatory classifications and requirements for medical devices.
• Indications for Use for the specific device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the document does not discuss these aspects for an AI/ML or diagnostic device. The device in question is a simple medical device (a saline syringe), not one that would typically undergo the kind of performance studies involving AI, ground truth, expert readers, or MRMC studies.

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Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow.

Enteral Pump Syringe is intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.

Enteral Pump Syringe is intended for neonatal, pediatric and adult use.

Enteral Pump Syringe is single use device.

The proposed device is modified device of K190502(ENFit Oral/Enteral Syringe,cleared July 2, 2019) according to 21CFR 820.30. The change is a operation mode change from manual use to use with infusion pump.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml to 60ml. The ENFit enteral feeding syringe consists of moveable plunger, piston, calibrated hollow barrel and tip cap(not necessary). At the distal end of the barrel is a female connector, designed according to ISO 80369-3 (often referred to as an ENFit connection). The tip is designed to mate only with enteral administration devices and is incompatible with Luer connectors. The device is used to deliver fluids into the body enterally by connected to an enteral access device with male ENFit connector. The syringes (size 6ml to 60ml) incorporate a female Standard ENFit connector; the syringes (size 1ml and 6ml) incorporate a female low dosing ENFit connector.

There are 2 types of ENFit connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 12ml to 60ml; and The sizes of the central connector ENFit syringe range from 1ml to 60ml. The syringes are provided with transparent or amber color barrel.

The material used of deviec are Polypropylene. Polyisoprene rubber, Polydimethysiloxane(inside surface coating of barrel ). Amber additive(for used amber color barrel only), which are also patient-contacting materials for the proposed devices. The time of contact duration is less than 24 hours. The contact level is mucosal membrane, indirect.

The proposed device is sterile or non-sterile, single use. The 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 five years.

The proposed device intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals. The device has no energy in itself. But the syringe works with infusion pump and extension sets.The syringe is aspirated nutritional formula liquid, connected the extension set. Then user installed it on the infusion pump, and pump fluids into a body enterally in a controlled manner for administer enteral nutrition. The accuracy of graduations for enteral syringes is +/- 4% of expelled volume.

This document is a 510(k) Premarket Notification for an "Enteral Pump Syringe." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device meets specific performance acceptance criteria through the kind of study described in the prompt. This device is a syringe, not an AI or imaging device, so the requested information regarding AI performance metrics, expert adjudication, MRMC studies, and ground truth establishment is not applicable.

Therefore, I cannot provide the requested information for an AI/imaging device. However, I can extract the information relevant to the performance and testing of this specific medical device, the Enteral Pump Syringe, as presented in the document:

Device: Enteral Pump Syringe

Context: This document is an FDA 510(k) submission, aiming to demonstrate "substantial equivalence" of the proposed device to an already legally marketed predicate device. It is not a clinical study report for an AI or imaging device.

Information that can be extracted from the provided text regarding this device's performance and testing:

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

The document primarily refers to compliance with established international standards rather than specific quantitative acceptance criteria and reported performance values in a table format. The "acceptance criteria" here are the requirements of these standards.

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "non-clinical tests" and "bench tests" to verify compliance with standards, but not the number of units tested.
• Data Provenance: Not specified, but likely from the manufacturer's internal testing facilities in China (Jiangsu Caina Medical Co., Ltd.). The tests are "non-clinical" (bench tests) and therefore not from patients.

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

This information is not applicable as this is a medical device (syringe) and not an AI or imaging device that requires expert-established ground truth from images or clinical data. The "ground truth" for this device's performance is adherence to engineering and biocompatibility standards measured through bench tests.

4. Adjudication method for the test set:

Not applicable. As above, this is not an AI/imaging device study requiring human reader adjudication.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by the international and national standards it is required to meet (e.g., ISO and ASTM standards for sterility, biocompatibility, connector compatibility, and physical performance). Compliance is shown through bench tests and material characterization, not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic or prognostic devices.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. This device does not involve machine learning.

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The Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direction, intermittent infusion, continuous infusion or aspiration.

The proposed device, Needleless Connector, is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The proposed device is a needleless connector which can be activated by a male luer, and the flush volume for the device is 5ml. The device can be used for less than 7 days and 100 activations.

The Needleless Connector also suitable for power injection of contrast media into the central venous system only through IV line that is also indicated for power injection at a maximum pressure of 325psi and a flow rate of 10ml/s.

The provided text is related to an FDA 510(k) premarket notification for a "Needleless Connector." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technical characteristics, rather than a study of an AI-powered device. 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 details the device's technical specifications, materials, and non-clinical performance tests (e.g., biocompatibility, sterility, integrity, fluid dynamics) to show it is as safe and effective as a previously cleared device. It explicitly states: "No clinical study is included in this submission."

To address your request, I would need a document describing an AI device and its associated clinical or performance study.

Ask a specific question about this device