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The ENFit® Reusable Enteral Syringe 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.

The proposed device with Enfit® connector (1ml-60ml) are standard piston style syringes consisting of syringe barrel with integral EnFit syringe tip, syringe plunger and ring type piston. The proposed device are supplied non-sterile, and reusable. The sizes rang from 1ml to 60ml 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.

This is a 510(k) summary for a medical device (ENFit Reusable Enteral Syringe). 510(k) submissions typically demonstrate substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical efficacy studies with acceptance criteria in the manner of AI/software devices. Therefore, the information requested in the prompt, especially related to AI-specific metrics, reader studies, and ground truth establishment, is not applicable or present in this document.

However, I can extract the non-clinical tests performed and mention that these tests serve as the "acceptance criteria" for demonstrating substantial equivalence for this type of device.

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

The document lists various non-clinical tests performed to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests, and the implication that the device met their requirements, serve as the "reported device performance" and "acceptance criteria" for a 510(k) submission. No specific numerical thresholds are provided in this summary, but the successful completion of these tests indicates compliance.

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

The document does not specify the sample sizes for each non-clinical test conducted. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are material performance tests rather than clinical 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 is a physical medical device (syringe), not an AI/software device that requires expert ground truth for classification or diagnosis. Therefore, this information is not applicable and not present in the document.

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

Not applicable, as this is not an AI/software device or a study involving human interpretation with 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 a physical medical device. No MRMC study was conducted or reported.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For these physical device tests, the "ground truth" is defined by the established industry standards (e.g., ISO 14971, ISO 7886-2, ISO 10993 series, ISO 80369-3) and pre-defined specifications for device performance (e.g., freedom from leakage, specific dimensions, resistance to force). The device's performance against these verifiable physical and chemical metrics serves as the ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software device requiring a training set.

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

Not applicable.

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Wealy ENFit® Disposable Enteral Syringe 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 setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~100ml. This device incorporates a female ENFit® connector for connection to an enteral access device with male ENFit® connector. The proposed syringe is 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 document is a 510(k) summary for the ENFit® Disposable Enteral Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and detailed performance of an AI-powered diagnostic device. Therefore, many of the requested categories (expert ground truth, MRMC study, training set details) are not applicable as this is a medical device for fluid delivery, not an AI diagnostic.

However, I can extract the relevant information regarding acceptance criteria and performance based on the non-clinical tests described.

Here's a breakdown of the information that can be extracted from the provided text:

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

The document lists various tests based on international standards (ISO, ASTM, USP). The reported performance is generally stated as "The testing demonstrates the proposed devices conform to the requirements" or "Conforms to the requirement of [standard]". Specific quantitative acceptance criteria are given by referencing clauses within these standards, implying that the device met those quantitative values.

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

The document does not explicitly state the sample sizes used for each specific test in the non-clinical performance testing. It also does not specify the country of origin of the data (beyond the manufacturer being in China) or whether it was retrospective or prospective, as these are non-clinical hardware tests.

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 an enteral syringe for fluid delivery, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is not a diagnostic device involving expert 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 device is not an AI diagnostic or image analysis tool, so an MRMC study is irrelevant.

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 or AI.

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

For a medical device like a syringe, "ground truth" is established by adherence to recognized international performance standards (ISO, ASTM, USP). For example, the "ground truth" for fluid leakage would be the acceptable limits defined in ISO 80369-3, and the device passing means it met those objective, standardized measures. For biocompatibility, the ground truth is defined by the toxicological profiles and testing methods in the ISO 10993 series.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this type of device.

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The Automatically Retractable Safety Syringes with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

The Automatically Retractable Safety Syringes with Fixed Needle devices are piston syringes, intended for medical purposes and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. The Automatically Retractable Safety Syringes with Fixed Needle are sterile, single use, disposable and non-reusable.

This document is a 510(k) premarket notification for an "Automatically Retractable Safety Syringe with Fixed Needle". It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, many of the requested categories related to AI/algorithm performance studies (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.

However, I can extract information related to "acceptance criteria" through the lens of performance testing conducted to show substantial equivalence.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantitative "acceptance criteria" and their corresponding "reported device performance" values in the format typically seen for algorithm validation. Instead, it refers to general performance testing to demonstrate substantial equivalence.

Explanation of "Acceptance Criteria" in this context: For a physical medical device like a syringe seeking 510(k) clearance, "acceptance criteria" are typically defined by recognized standards (e.g., ISO standards for syringes, biocompatibility standards) and the internal design specifications of the manufacturer. The document states that testing was done "appropriately for design verification, design validation, biocompatibility and sterilization," implying that the device met these established criteria without specifying the exact numerical thresholds.

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

• Sample Size for Test Set: Not specified in the document. The document mentions "performance testing" but does not detail the number of units tested.
• Data Provenance: Not specified. It's likely the testing was conducted by the manufacturer, Shantou Wealy Medical Instrument Co. Ltd, in China, given their location. The nature of the testing (design verification, biocompatibility, etc.) suggests it would be prospective testing of newly manufactured devices.

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 instrument, not an AI/algorithm-driven diagnostic device that would require expert-established ground truth.

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

Not applicable. This is not an AI/algorithm study requiring adjudication of diagnostic outputs.

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/algorithm-driven 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.)

Not applicable in the AI/algorithm sense. For a physical device, "ground truth" would be established by objective measurements against engineering specifications and relevant ISO/ASTM standards (e.g., fluid delivery accuracy, plunger force, needle retraction force, material biocompatibility test results). The document refers to "test results" concluding the device passed these standards.

8. The sample size for the training set

Not applicable. There is no AI/algorithm training set for this physical device.

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

Not applicable. There is no AI/algorithm training set for this physical device.

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Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into the body. Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.

The provided document describes a 510(k) premarket notification for an Automatically Retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance in the way typically seen for diagnostic algorithms.

Therefore, the requested information elements related to specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and ground truth types are not applicable to this document's content.

However, I can extract the acceptance criteria and a summary of how the device meets them based on the equivalence testing performed to satisfy the 510(k) submission.

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

The acceptance criteria are implied by the comparison to the predicate device and relevant industry standards. The reported device performance is that it meets these criteria, demonstrating equivalence.

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 submission focuses on demonstrating substantial equivalence through comparison of design, intended use, and similar safety and performance testing to the predicate device. Details about the specific sample sizes or data provenance for these tests are not included.

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

This is not applicable as the document describes a medical device (syringe) rather than a diagnostic algorithm that requires expert-established ground truth. The "ground truth" here is compliance with established standards and performance metrics for the device itself, verified through engineering and biocompatibility testing.

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

This is not applicable for the same reasons as #3.

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

This is not applicable as the device is a syringe, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a syringe, not a standalone algorithm.

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

The "ground truth" for this device's performance is established by international standards (e.g., ISO 7886-1:1993, ISO 10993-1) and the performance characteristics of the legally marketed predicate device (VanishPoint™ Syringe K970803). The device demonstrates "conformance" to these standards and "similarity" to the predicate.

8. The sample size for the training set

This is not applicable as the document describes a medical device, not a machine learning model requiring a training set.

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

This is not applicable for the same reasons as #8.

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