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Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and and/or injection.

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The provided FDA 510(k) clearance letter pertains to Monoject™ Syringes, which are physical medical devices (piston syringes) and not an AI/ML software device. Therefore, the concepts of acceptance criteria for algorithm performance, study methodology for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this document.

The letter indicates that the device has received substantial equivalence to legally marketed predicate devices, meaning it meets the safety and effectiveness requirements for its intended use, which is general purpose fluid aspiration and/or injection by healthcare professionals.

To answer your request, if this were an AI/ML device, the information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided FDA clearance letter. The letter itself is a notice of clearance, not a detailed technical report of the studies performed.

Therefore, I cannot extract the requested information from the provided document as it does not contain details about an AI/ML study or its performance criteria.

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The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The orallenteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

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This document is an FDA 510(k) clearance letter for the Monoject™ Enteral Syringe with ENFit Connector. It does not contain any information regarding acceptance criteria or a study proving that a device meets those criteria for software or AI/ML-enabled devices.

The letter is a regulatory document indicating that the FDA has determined the device to be substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's intended use, technological characteristics, and safety and effectiveness to an existing, legally marketed device.

Therefore, I cannot provide the requested information from this document. The document discusses regulatory aspects like:

• Trade/Device Name
• Regulation Number and Name
• Regulatory Class
• Product Code
• Indications for Use
• General controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, misbranding, adulteration)
• Quality System (QS) regulation requirements
• Unique Device Identification System (UDI Rule)
• Medical Device Reporting (MDR)
• Contact information for the FDA.

However, none of these sections detail acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided for AI/ML device submissions.

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Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.

The provided text is a 510(k) summary for a medical device (Monoject Magellan Insulin Safety Syringe). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not contain any information about an AI/ML-driven device or its acceptance criteria and study results. The device described is a physical medical device (syringe), not a software or AI/ML product.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study results for an AI/ML device based on the provided text. The questions posed (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set data) are relevant to the evaluation of AI/ML models, but the provided document is not about such a device.

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The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The oral/enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The Monoject™ Enteral Syringes with ENFit Connector are provided in sizes of 1mL to 60mL, sterile or non-sterile. The device (sizes 6mL to 60mL) incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector. The device specific for low dose applications (sizes 1mL & 3mL) incorporates a female ENFit Syringe tip with an internal tip lumen for connection to an enteral access device with male ENFit connector.

The provided document is a 510(k) summary for the Monoject™ Enteral Syringe with ENFit Connector. It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria for an AI or diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how training set ground truth was established) are not applicable to this type of device and submission.

However, I can extract the relevant acceptance criteria and reported performance from the non-clinical testing described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test.
Data provenance is internal testing performed by Covidien for regulatory 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 performance study based on engineering and material standards, not expert clinical interpretation of data.

4. Adjudication method for the test set:
Not applicable. This is a non-clinical device performance study based on engineering and material 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-AI medical device (syringe).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device (syringe).

7. The type of ground truth used:
For most tests (Fluid Leakage, Stress Cracking, Resistance to separation, Resistance to overriding, Disconnection by unscrewing, Dimensional Analysis), the "ground truth" is defined by established engineering and material standards (AAMI /CN3 (PS):2014 and ISO 80369-20). For biocompatibility, it's safety standards. For stability, it's product integrity after aging. For dosing accuracy and usability, it's functional performance.

8. The sample size for the training set:
Not applicable. This is a non-AI medical device (syringe).

9. How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device (syringe).

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The Monoject™ Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in sizes of 1mL and 3mL. The device specific for low dose applications incorporates a female ENFit Syringe tip with an internal tip lumen for connection to an enteral access device with male ENFit connector.

This document is a 510(k) premarket notification for the Monoject™ Enteral Feeding Syringe with ENFit Connector. As such, it details the non-clinical testing performed to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study proving the device meets specific performance criteria against a ground truth.

Therefore, many of the requested sections related to clinical studies, expert-established ground truth, and human reader performance will not be applicable or available from this document.

Here's an analysis of the provided information based on your request:

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a non-clinical evaluation for a medical device (enteral feeding syringe), the "acceptance criteria" are based on the requirements of recognized industry standards. The "device performance" is reported as conformity to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of syringes tested for fluid leakage). It generally states that "Testing performed on the Monoject™ Enteral Feeding Syringes with low dose tip ENFit Connectors included the items listed below..."
• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Covidien, based in Mansfield, MA, USA. The data is thus internally generated non-clinical test data. It is neither retrospective nor prospective in the clinical sense.

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

Not applicable. For non-clinical device testing verifying compliance with standards, "experts" in the sense of clinical specialists establishing a "ground truth" are not relevant. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO and AAMI standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions. Device performance is assessed directly against the objective criteria of the specified standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes a 510(k) submission for an enteral feeding syringe, which is a physical medical device. It does not involve AI, image analysis, or human readers, so an MRMC comparative effectiveness study is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software device or an algorithm.

7. Type of Ground Truth Used

The "ground truth" for these tests is the set of objective, measurable requirements specified in the following international and industry standards:

• AAMI /CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications.
• ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
• ISO 7886-1, Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use.
• Biocompatibility standards (not explicitly listed, but implied by "Biocompatibility testing has demonstrated the biological safety").

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable, as there is no training set. The relevant "ground truth" for non-clinical performance evaluation is established by international and industry consensus standards.

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The Monoject™ Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The Monoject™ Enteral Feeding Syringe with ENFit Connector is a disposable enteral feeding syringe provided in a variety of sizes from 6mL to 60mL. The device incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector.

The provided document is a 510(k) premarket notification for a medical device, specifically an enteral feeding syringe. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI algorithm or an acceptance criteria study related to an AI device's performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria because the document is not about an AI device.

However, I can extract the acceptance criteria and test results for the physical characteristics of the Monoject™ Enteral Feeding Syringe with ENFit Connector, as detailed in the "Nonclinical testing" section.

Here's the information adapted to the prompt's structure for the physical device, recognizing this is not an AI study:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of syringes tested for fluid leakage). It mentions "accelerated aging" for stability testing, implying lab-based, prospective testing conducted by the manufacturer, Covidien, based in Mansfield, MA, USA.

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

Not applicable. This is not an AI device or a study requiring expert human interpretation for ground truth establishment. The ground truth for physical tests is based on objective measurements against international standards (ISO 80369 series and AAMI /CN3 (PS):2014).

4. Adjudication method for the test set

Not applicable. The tests are objective physical measurements against predefined 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

Not applicable. This is not an AI device or a study involving human readers.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

For the physical tests, the ground truth is based on objective measurements against established international and industry standards. For example, fluid leakage is "true" if the device meets Clause 6.2 of AAMI /CN3 (PS):2014.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

Not applicable.

Summary regarding the device:

The Monoject™ Enteral Feeding Syringe with ENFit Connector underwent non-clinical testing to demonstrate its substantial equivalence to predicate devices and conformity to relevant standards (ISO 80369-3, ISO 80369-20, and AAMI /CN3 (PS):2014). The testing covered aspects like fluid leakage, stress cracking, resistance to separation, resistance to overriding, disconnection by unscrewing, dimensional analysis, biocompatibility, and stability. All tested parameters met the specified criteria in the relevant standards. Clinical testing was not deemed necessary for the demonstration of safety and effectiveness.

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The syringe is intended to inject or withdraw fluids from the body.

The Monoject 60mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and an attached gasket. It is available in three nozzle types: Luer lock, luer slip and catheter tip. The barrel is made from polypropylene and is designed with clear graduation for easy use. The luer barrel nozzle has an ISO 594 compliant male luer tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 30 devices, and the master case contains 12 inner boxes. This syringe is sterilized by gamma irradiation.

The provided text describes a 510(k) summary for a medical device, specifically the Monoject 60mL Syringe. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study with acceptance criteria and a detailed report of how a device meets those criteria in the context of an AI-powered system or a study involving human readers.

Therefore, most of the requested information (points 1, 2, 3, 4, 5, 6, 7, 8, 9) is not applicable or cannot be extracted from the given text because:

• This is a traditional medical device (syringe), not an AI/ML-powered device. The 510(k) summary details performance tests for a physical product (syringe), not an algorithm's performance.
• The document focuses on non-clinical performance testing for safety and effectiveness, not clinical trials with human subjects or AI-assisted performance.
• The concept of "ground truth," "experts," "adjudication," "training set," and "test set" as typically understood in the context of AI/ML or comparative effectiveness studies of diagnostic algorithms is not relevant here. The "ground truth" for a syringe is its physical specifications and functionality.

However, I can extract information related to the performance testing and conclusions based on the provided text, aligning with the spirit of "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific type of device.

Acceptance Criteria and Device Performance (Interpreted for a Syringe Device)

The "acceptance criteria" for the Monoject 60mL Syringe are implicitly defined by the successful completion of the non-clinical performance tests, proving the device is safe and effective and comparable to predicate devices. The "reported device performance" is that it met these test requirements.

Here's a breakdown of the specific points related to the provided 510(k) summary, acknowledging the context of a traditional medical device:

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

   • See the table above. The acceptance criteria are implicitly met by successful completion of the listed non-clinical tests, and the reported performance is that these tests were passed, leading to the conclusion of safety, effectiveness, and substantial equivalence.

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 specify the exact sample size for each performance test. It only states that "Performance testing was conducted."
   • Data Provenance: Not specified. This typically refers to the testing done by the manufacturer (Nipro Medical Corporation) or a contracted lab. The country of origin of the data is not mentioned, nor is whether the data is retrospective or prospective, as these terms are less relevant in the context of physical product performance testing for regulatory submission.

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

   • Not applicable. For a physical device like a syringe, "ground truth" is established by adherence to engineering standards, material specifications, and performance requirements. There are no "experts" in the sense of medical reviewers establishing ground truth for diagnostic accuracy, as this is not a diagnostic device. The tests themselves, conducted by qualified engineers/technicians following standardized protocols, serve as the verification.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical trials or expert reviews, especially for diagnostic outputs. For objective performance tests of a physical device, the outcome is measured by instrumentation against defined limits, not adjudicated by human consensus.

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 not an AI-powered device, nor is it a diagnostic device that involves human "readers." Therefore, an MRMC study is completely irrelevant here.

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

   • No. This is a physical medical device (syringe), not an algorithm.

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

   • The "ground truth" for this device's performance is objective, defined by established engineering and performance standards for syringes (e.g., ISO 594 compliance, specified limits for force, leakage, etc.) and the material properties required for biocompatibility.

8. The sample size for the training set:

   • Not applicable. This term relates to machine learning (AI), which is not involved in the development or testing presented for this syringe.

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

   • Not applicable. As above, this is an AI/ML concept and does not apply to this traditional medical device submission.

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The syringe is intended to inject or withdraw fluids from the body.

The Monoject 12 mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and attached gasket. The barrel is made from polypropylene and is designed with clear graduation for easy use. The barrel nozzle has an ISO 594 compliant male 6% taper luer lock tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 100 devices, and the outer box contains 10 inner boxes. This syringe is sterilized by gamma irradiation.

The provided text describes the 510(k) summary for the Monoject 12mL Syringe (K130049). It details the device's characteristics, intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness.

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

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

The document lists various performance tests conducted. It implies that the acceptance criteria for these tests would be compliance with established standards or achieving results comparable to the predicate device. The reported performance is that the device meets these criteria and performs equivalently to the predicate device.

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

The document states that "Performance testing was conducted to verify that the device is safe and effective for its intended use." However, it does not specify the sample size used for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically detailed in the full test reports that are part of the submission but not included in this summary.

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

The document describes non-clinical performance testing, which generally refers to laboratory or bench testing of the device itself against established standards or specifications. This type of testing typically does not involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies would. Therefore, this information is not applicable to the described study.

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

As mentioned above, the testing described is non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where subjective interpretation of results might be involved. Since this is for a syringe, a physical medical device, such adjudication methods are not applicable. The results of the performance tests are generally objective measurements against predefined specifications.

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 a physical medical device (syringe), not an AI or diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.

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

Again, this is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For the non-clinical performance tests, the "ground truth" is established by technical specifications, industry standards (e.g., ISO 594 for luer taper), and internal design requirements. For example, the "ground truth" for liquid leakage is "no leakage" when tested under specified conditions, or for force required to operate plunger, it's a specific range of force. There isn't a "pathology" or "outcomes data" type of ground truth for a syringe's physical performance.

8. The sample size for the training set:

As this is a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are honed through engineering principles and quality control, not through training data.

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

Since there is no training set (as per point 8), this question is not applicable.

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These devices are intended for the injection of medications into or the withdrawal of body fluids from parts of the body below the surface of the skin.

The devices consist of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

This document does not describe an AI/ML powered medical device. It details a 510(k) premarket notification for 30 Gauge Monoject® Hypodermic Needles.

Therefore, I cannot provide the information requested regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as these concepts are specifically relevant to the evaluation and validation of AI/ML algorithms, not hypodermic needles.

The document indicates that the device's substantial equivalence is based on its conformity to recognized safety and performance consensus standards for needles (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2, and ISO 6009) and its similarity in design and intended use to predicate devices.

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The device is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The proposed device consists of a sterile syringe, labeled for either U-100 Insulin or Tuberculin, with a permanently attached single lumen needle, and an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip or thumb operation or by pressing the shield. Once activated, the safety shield is securely and permanently locked.

The provided text is a 510(k) summary for the Kendall Monoject® Safety Syringe. It describes the device, its intended use, and its substantial equivalence to a previously marketed device. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria for performance, such as diagnostic accuracy or clinical outcomes.

The nonclinical testing mentioned (Biocompatibility testing) only states that the device meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. This is a general safety standard, not a performance study.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document focuses on regulatory approval through substantial equivalence, primarily by comparing the new device's design and intended use to a predicate device and confirming biocompatibility, rather than providing detailed performance data against specific acceptance criteria.

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