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

Profoject™ Enteral Feeding Syringe provided in a variety of sizes from 0.5mL to 60mL. It consists of plunger, plunger stopper, barrel, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector.

The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10⁻⁶ and supplied sterility maintenance package. The shelf life of both sterile and non-sterile proposed devices has been validated as 5 years.

This looks like a 510(k) clearance letter for a medical device that is NOT an AI/ML device. Therefore, the questions related to AI/ML device evaluations (such as test set, ground truth, expert qualifications, MRMC studies, and training set) are not applicable.

The document describes the non-clinical test conclusions for the Profoject™ Enteral Feeding Syringe.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was evaluated against several ISO and ASTM standards, as well as USP-NF monographs. The acceptance criteria are implicitly those defined by these standards, and the reported performance is that the device "Complied with" these standards.

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

The document indicates that non-clinical verification was performed. This typically involves laboratory testing on device prototypes or production samples. The specific sample sizes for each test are not provided in this summary. Data provenance would be from laboratory testing conducted by or for CMT Health PTE. Ltd. (Singapore), likely in a controlled, prospective manner as part of the device development and validation process.

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

This question is not applicable as the device is a physical medical device (enteral feeding syringe), not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for non-clinical performance and safety relates to adherence to recognized standards and specifications, which are typically evaluated by engineers and quality assurance professionals, not clinical experts for ground truth establishment.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies for AI/ML algorithms. This document describes non-clinical performance and biocompatibility testing.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant.

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

Not applicable. This is not an AI/ML device.

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

For non-clinical testing of a physical device, the "ground truth" is defined by the technical specifications, performance limits, and safety requirements outlined in the referenced ISO, ASTM, and USP standards. For example, for dose accuracy, the ground truth is the specified ±10% accuracy. For sterility, it's the SAL of 10⁻⁶. For biocompatibility, it's the absence of cytotoxicity, irritation, or sensitization as defined by the ISO 10993 series. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML 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 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.

Not Found

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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NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric and adult patient populations. These devices are intended to be used in clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).

The Nutricair™ enteral syringe with ENFit is sterile, single use device. It is provided in size 10 ml. It consists in a body with ENfit connector in polypropylene, a plunger in polypropylene and a piston seal in isoprene. This device incorporates a female ENFit connection to enteral access device with a male ENFit connector that is compliant to ISO 80369-3. Graduations from 1 to 10 ml are printed on the body. The 10 mL syringe model number is NCE10SE.

The provided text describes a 510(k) premarket notification for a medical device called "Nutricair Enteral Syringe with ENFit," which functions as an enteral feeding syringe. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or conducting clinical trials.

As such, the information you're requesting regarding acceptance criteria and studies demonstrating a device meets acceptance criteria, an AI-driven system, ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable to this document.

This submission focuses on engineering and performance criteria to show the new device performs as safely and effectively as an existing one, usually through non-clinical bench testing and comparative analysis of design features.

Here's a breakdown of why your specific questions generally don't apply to a 510(k) for a physical medical device like a syringe, based on the provided text:

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

  • The document largely relies on meeting established international standards (e.g., ISO) for medical devices, particularly those related to syringes and enteral connectors. The "acceptance criteria" are these standard requirements, and the "reported device performance" is that the device met these standards.
  • The table on pages 6-7 ("Table 5-1: Device comparison table") highlights comparisons to the predicate device and states "Equivalent" or "Similar" and "No impact on safety or performance" as the outcome, indicating that existing standards and comparative performance are the basis for acceptance.
  • Section VIII, "Performance Testing," lists the types of tests performed (biocompatibility, visual inspections, enteral device performance tests, enteral connector performance tests, risk analysis, usability analysis) and the standards they comply with (e.g., ISO 10993, ISO 20695, ISO 7886-1, ISO 80369-20, ISO 80369-3, ISO 14971, ISO 62366-1). The acceptance criteria for each of these would be the specific quantitative or qualitative limits defined within those ISO standards. The document states that the device "met updated standard ISO 20695:2020" or "met the standards of 80369-3." However, specific numeric performance results are not typically included in these public 510(k) summaries unless a deviation from a standard is justified or an equivalence needs quantitative proof for a specific parameter.

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

  • For physical product testing as described (e.g., fluid leakage, stress cracking, barrel dimensions), sample sizes are typically defined by the test protocols within the relevant ISO standards (e.g., a certain number of syringes tested per batch). This information is generally not included in the 510(k) summary itself, as it's part of the detailed test reports provided to the FDA.
  • Data provenance for such physical device testing is typically the manufacturer's internal testing labs or third-party accredited labs. Country of origin for testing is not specified, but the manufacturer is based in France. The testing is retrospective in the sense that it was completed before the submission to demonstrate compliance.

• 3. Number of experts used to establish the ground truth... and their qualifications:

  • This is not applicable. There is no "ground truth" in the diagnostic AI or clinical outcome sense for a basic physical device like a syringe. The "truth" is whether it meets engineering specifications and safety standards defined by regulatory bodies and consensus standards. These are established through engineering principles, laboratory testing, and risk assessment by qualified engineers and scientists.

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

  • Not applicable. This concept pertains to human review of diagnostic imaging or clinical findings for establishing ground truth, which is not relevant here.

• 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/software device that would involve human readers or diagnostic interpretation.

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

  • Not applicable. This is not an AI/software device.

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

  • As explained in #3, "ground truth" in the diagnostic sense is not applicable. The "truth" is whether the physical device meets its specified engineering performance parameters and safety requirements, as verified through standard laboratory tests and adherence to ISO standards.

• 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. No training set is involved.

In summary: The provided document is an FDA 510(k) clearance summary for a disposable medical syringe. The "acceptance criteria" are the relevant ISO standards for medical device safety and performance, and the "study" is a series of non-clinical, bench-top engineering tests demonstrating compliance with these standards and substantial equivalence to a predicate device. Concepts related to AI/ML performance, diagnostic ground truth, or multi-reader studies are entirely outside the scope of this particular device and its regulatory submission.

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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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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ENFit Nutrifit™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow. The 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 to administer enteral fluids. ENFit Nutrifit™ enteral syringes are single use devices. ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.

An enteral syringe consists of a syringe barrel with integral tip (ENFit), plunger, gasket, barrel lubricant and can be supplied with or without a syringe tip cap. Only the 5mL single use syringe can be connected with compatible enteral syringe-driver pumps; the other syringes are for manual use.

The provided document is a 510(k) Premarket Notification for ENFit enteral syringes, which are medical devices used for delivering enteral fluids. It outlines the regulatory process for clearance, not a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing and conformance to established standards, rather than clinical studies with human participants.

Therefore, I cannot provide the information requested in the prompt's structured format (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types, training set details) because this document does not describe such a study for an AI/ML powered device.

The document details the following about the device's testing and intended performance:

• Device Type: ENFit enteral syringes (NUTRIFIT™)
• Intended Use: Delivering enteral fluids to the gastrointestinal system of patients unable to eat and swallow. Intended for use in clinical or home care settings by laypersons (under supervision) and clinicians, for pediatric and adult use.
• Regulatory Class: Class II (Product Code: PNR, Regulation Number: 21 CFR 876.5980 - Gastrointestinal tube and accessories).
• Predicate Device: ENFit enteral pump syringes PENTA™/ENFit enteral pump syringes NUTRIFIT™ (K161141).
• Testing and Evaluation:
  • Performance test: According to ISO 7886-1/-2 & ISO 80369-3/-20, including testing after simulated clinical use and cleaning.
  • Biocompatibility tests: According to ISO 10993 series requirements.
  • Sterility validation and tests: According to ISO 11135.
  • Packaging validation and tests: According to ISO 11607-1/-2.
  • Labeling requirements: According to ISO 15223-1 and FDA Guidance "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications."
• Conclusion: The tests demonstrated that the ENFit enteral syringes NUTRIFIT™ are safe and effective, meet their intended use, and are similar to the predicate device in terms of intended use, indications for use, and medical technique.

The document emphasizes compliance with international standards (ISO) and FDA guidance for medical devices, specifically for physical characteristics, sterility, biocompatibility, and packaging, rather than performance metrics related to diagnostic accuracy, image interpretation, or other tasks that would involve AI/ML algorithms and require the types of studies outlined in your request.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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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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