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Sterile syringe bulk tray is sterile, single-use, and bulk packaged syringes for liquid aspiration and injection procedures.

The sterile syringe bulk tray is designed for manual and single use. It includes multiple syringes and a bulk tray. Each syringe consists of a barrel, plunger stopper (piston). The barrel and plunger are made from polypropylene, while the plunger stopper is made from lsoprene rubber. The device is available in different syringe volumes and offers both Luer slip (1mL) and Luer lock (1, 3, 5, 10, 20, 30, 50, 60mL) connectors. The Luer connector is used to connect the syringe to a hypodermic needle for liquid injection or withdrawal.

The medical device is enclosed in a thermal-formed plastic tray that is protected by dialyzing paper. It is sterilized using EO gas to ensure a shelf life of 5 years. The bulk tray packaging of the device is advantageous for performing batch liquid injections or withdrawals.

In order to maintain sterility, it is advised to utilize the device within 5 hours after the bulk tray has been opened. This device is specifically designed for application in aseptic environments and should only be handled by medical professionals.

The provided document describes a 510(k) premarket notification for a medical device: "Sterile Syringe Convenience Tray" (K230447). This document demonstrates substantial equivalence to a predicate device, focusing on the device's technical specifications, non-clinical performance, and biocompatibility, rather than clinical efficacy studies.

Therefore, the specific information requested about acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML-based medical devices or diagnostics) is not present in this document.

The document discusses performance through non-clinical testing against established ISO standards for syringes and biocompatibility, as well as sterility and packaging integrity. It does not involve human interaction or interpretation of data in the way an AI/ML diagnostic device would.

Here's why the requested information cannot be extracted from this document:

• Device Type: This is a physical medical device (syringe tray), not a software or AI-based diagnostic tool.
• Approval Pathway: The 510(k) pathway for this type of device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, material properties, manufacturing processes, and compliance with performance and safety standards (like ISO standards for sterile syringes). It does not typically require clinical trials in the sense of demonstrating diagnostic accuracy or treatment effectiveness on human patients.
• "Acceptance Criteria" in this context: For this device, "acceptance criteria" are met by demonstrating compliance with the referenced ISO standards for syringe performance (e.g., flow rate, leakage, plunger operation, tolerance on graduated capacity) and biocompatibility, as well as sterility and packaging integrity. There's no "algorithm performance" to be evaluated against a human expert panel.

General Summary of Acceptance in this Document's Context (as much as can be inferred):

The acceptance of this device for 510(k) clearance is based on the satisfactory completion of non-clinical tests that demonstrate its safety and performance align with established international standards for syringes. The "study" proving this involves a series of laboratory tests as detailed below.

Regarding your specific points, based on the provided document:

1. A table of acceptance criteria and the reported device performance:
   The document lists the standards the device was tested against. The "reported device performance" is that the results met the requirements of these standards.

   Acceptance Criteria (Standards Met)	Reported Device Performance
   ISO 7886-1:2017 (Syringe Performance)	Met requirements
   ISO 80369-7:2016 (Luer Connectors)	Met requirements
   ISO 80369-20:2015 (Luer Connectors)	Met requirements
   ISO 10993-1 (Biocompatibility)	Complied (Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Hemolysis, Pyrogen)
   USP (Residual Particles)	Tested, compliant
   USP (Endotoxin)	Tested, compliant
   ISO 11135 (Sterilization)	Validated, compliant (EO/ECH residuals)
   ASTM F1980-16 (Accelerated Aging/Shelf-Life)	Verified 5 years shelf-life
   ASTM D4169-16 (Shipping Conditions/Package Integrity)	Deemed acceptable
   ASTM F88/F88-15 (Seal Strength)	Tested, compliant
   ASTM F1929-15 (Dye Penetration)	Tested, compliant
   USP (Sterility)	Tested, compliant

2. Sample sized used for the test set and the data provenance: Not specified in the document. These would refer to the number of syringes tested for each specific non-clinical test (e.g., how many syringes were tested for leakage or force to operate the piston). The data provenance is implied to be from laboratory testing conducted as part of the device manufacturer's validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a syringe is established by engineering specifications, material science, and performance standards, measured by calibrated equipment, not by human expert interpretation or consensus.

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not a diagnostic AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not an algorithm. Standalone performance refers to the device meeting its performance specifications independently, which is implied by the testing against ISO standards.

7. The type of ground truth used: Engineering specifications, material properties, and compliance with established performance standards (e.g., ISO 7886-1 for syringe performance, ISO 10993 for biocompatibility).

8. The sample size for the training set: Not applicable. This is not an AI/ML device with a "training set."

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

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The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).

The Sterile Aesthetic Cannula and Hypodermic Needle is a combined medical device, including a blunt needle-cannula and a hypodermic needle. The sharp needle consists of a needle hub, a needle, and a protective cap. The blunt needle-cannula consists of a needle hub, a blunt cannula, and a protective cap. The device is provided for single-used, sterilized, and prescription use only. It offers various model configurations, including multiple needle gauge sizes, lengths, and tips, to fit most usage scenarios.

This document does not contain an AI/ML device. Therefore, the requested information elements related to AI/ML device performance, such as acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable and cannot be extracted.

The document describes a Sterile Aesthetic Cannula and Hypodermic Needle (K223327), which is a conventional medical device. The information provided is primarily about its physical and biological performance testing to demonstrate substantial equivalence to a predicate device.

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Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.

KDL Sterile Syringes for Single Use are composed of barrel, plunger, and a moveable piston. The plunger does not contact any part of the fluid path, rather the plunger which attaches to the piston and the barrel are fluid path components. Materials of construction for the components have been shown to meet the applicable requirements of ISO 10993-1. Additionally, there is a small amount of lubricant for moving the plunger smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals. The Sterile Syringes for Single Use have different specifications, include 1ml, 3ml, 10ml, 20ml and 30ml.

The provided text is a 510(k) summary for the "Sterile Syringes for Single Use". This document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes compliance with recognized international standards (ISO and ASTM) and specific tests conducted. The "Performance" column in the table below represents the device's conformance to these standards and the completion of the described tests.

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

The document does not specify the sample sizes used for any of the performance tests. It only states that the device was "tested" and "evaluated."

Regarding data provenance: The testing appears to be conducted by the manufacturer, Shanghai Kindly Enterprise Development Group Co., Ltd. within China, or by a testing facility on their behalf. The studies are prospective as they are conducted specifically to support this regulatory submission for the proposed device (non-clinical 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 section is not applicable to this device and the type of studies conducted. The device is a sterile syringe, and the studies are primarily non-clinical performance and biocompatibility tests against established international standards. "Ground truth" in the context of expert consensus (like in AI/medical imaging studies) is not relevant here. The "ground truth" is defined by the technical specifications and performance requirements of the ISO and ASTM standards.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting results, especially in complex diagnostic scenarios or AI performance evaluation. The studies for this device are non-clinical, laboratory-based performance tests against 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

This is not applicable. The device is a disposable, manually operated syringe, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or warranted.

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

This is not applicable. The device is a physical medical device (syringe), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

The "ground truth" for the non-clinical tests is based on established international standards and validated testing methodologies described within those standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series, USP , ISO 11135, ASTM F88/F88M-15, ASTM F1929-15, ISTA 3A:2018, ASTM F1980-16). These standards define acceptable performance limits and test procedures.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or deep learning algorithms.

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

This is not applicable for the same reason as point 8.

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The Sterile Safety Syringes for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.

The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.

The provided text describes the 510(k) premarket notification for "Sterile Safety Syringes for Single Use." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria in the manner one would see for an AI/ML medical device or a novel product requiring a clinical trial.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially those related to clinical studies, human expert involvement, ground truth, and training data for AI/ML) are not applicable to this type of submission.

However, I can extract information related to the technical performance tests conducted to show equivalence.

Here's a breakdown based on the provided document:

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

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical outcomes, but rather lists the standards to which the device conforms and the results of the tests confirming that conformity. The "acceptance" is that the device's performance meets the requirements of these recognized standards.

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

• Sample Size: The document does not specify the exact number of units tested for each standard. This level of detail is typically found in the full test reports, which are summarized in the 510(k) submission.
• Data Provenance: The tests were non-clinical performance tests conducted for the purpose of demonstrating substantial equivalence. The document doesn't explicitly state the country of origin for the testing data, but the manufacturer is based in Shanghai, China. The tests are "retrospective" in the sense that they were completed prior to this submission for regulatory review.

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 submission refers to a traditional medical device (syringes), not an AI/ML device or one requiring human expert interpretation of complex data for "ground truth" establishment. The "ground truth" for these tests is defined by the objective measurements and pass/fail criteria specified within the referenced ISO and ASTM standards.

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

• Not applicable. See point 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:

• No. This type of study is relevant for diagnostic devices interpreting complex data (e.g., radiology images) and involving human readers. It is not applicable to a safety syringe.

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

• Not applicable. This isn't an algorithm. The "performance" is mechanical and material integrity.

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

• For this device, the "ground truth" is established by the objective, quantitative requirements and methods defined in the listed international and national standards (ISO, ASTM, USP) for sterility, biocompatibility, and physical performance of hypodermic needles and syringes. For instance, a test for "Force to activate safety mode" would have a defined NMT (Not More Than) value (e.g., 10N), and passing means the device operates within that mechanical specification.

8. The sample size for the training set:

• Not applicable. This refers to machine learning. No training set was used for a physical syringe.

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

• Not applicable. See point 8.

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The safety needles are intended to be used with a Luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

The KDL Safety Needle is a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath could be manually activated when the needle is withdrawn from the body before disposal, minimizing the risk of needle sharps injury during disposal. It is activated manually by hand or any solid surface. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The KDL Safety Needle has various colors, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the KDL Safety Needle is sterilized by ethylene oxide and without any pyrogen or latex.

This document is a 510(k) Premarket Notification from the FDA regarding "KDL Safety Needles". It details the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Based on the provided text, the device in question is a hypodermic needle with a safety shield, not an AI/ML-driven device or a diagnostic aid. As such, the typical "acceptance criteria" and "study" framework for AI/ML medical devices (e.g., related to sensitivity, specificity, reader studies, ground truth establishment by experts, etc.) do not apply to this submission.

The document describes the testing performed for this device as non-clinical testing in conformance with various ISO and ASTM standards, which are primarily related to physical performance, sterility, and biocompatibility. There is an explicit statement: "No clinical testing is available for this device."

Therefore, I cannot provide the information requested in the prompt's numbered list, as it pertains to AI/ML device evaluation criteria that are not relevant to this submission.

The "acceptance criteria" for this device are its ability to meet the specified performance standards (e.g., ISO 7864, ISO 9626, ISO 23908), sterility requirements (e.g., ISO 11135), and biocompatibility requirements (e.g., ISO 10993 series). The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted according to these standards, as enumerated in section 8 of the 510(k) summary. These tests demonstrate the device's physical properties, sterility, and biological safety.

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The Sterile Safety Syringe for Single Use (Retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.

The proposed device, Sterile Safety Syringe for Single Use (Retractable), is available in 1ml. The proposed device consists of seven components:(1) protective cap, (2) needle tube, (3) connecting seat, (4) plunger stopper, (5) sliding sleeve, (6) barrel, (7) plunger. The proposed devices are sterilized by ethylene oxide to achieve a SAL 10-6 and supplied in sterility maintenance small package which could maintain the sterility of the device during the shelf life of 5 years.

The provided document is a 510(k) premarket notification for a medical device: "Sterile Safety Syringe for Single Use (Retractable)". It declares the device's substantial equivalence to a predicate device.

However, the document does not contain the acceptance criteria and performance data for a study proving the device meets those criteria in the format requested (i.e., a table of "acceptance criteria vs. reported device performance").

Instead, it lists various standard tests and their respective ISO/ASTM/USP standards that were applied to the device to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device. These tests primarily focus on:

• Biocompatibility: Adhering to ISO 10993 standards for biological evaluation.
• Sterility, Shipping and Shelf-Life: Meeting ISO 10993-7, USP, and ASTM standards for sterilization residuals, bacterial endotoxins, packaging integrity (seal strength, leak detection), and accelerated aging for a 5-year shelf life.
• Performance Testing: Conforming to ISO 7864 (hypodermic needles), ISO 7886-1 (hypodermic syringes for manual use), ISO 9626 (stainless steel needle tubing), and ISO 23908 (sharps injury protection features).
• Simulated Clinical Use Study: Conducted to evaluate the effect of the safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" and stated that "The test results demonstrated that the subject device complies with the requirements."

Therefore, I cannot extract the requested table of acceptance criteria and reported device performance from this document as it is not presented in that specific comparative format. The document primarily asserts compliance with established regulatory standards and guidelines through various tests, rather than detailing specific quantitative acceptance criteria and their corresponding empirical results in a side-by-side comparison for each performance aspect.

Moreover, the document explicitly states: "No clinical study is included in this submission." This means that information regarding human-in-the-loop performance, multi-reader multi-case studies, sample sizes for test sets involving human readers, expert consensus for ground truth, or adjudication methods are not applicable and thus not provided in this document. The device's safety feature validation was done through a simulated clinical use study, not a true clinical study with human subjects.

Given the limitations of the provided document, I can only state what is addressed and what is not:

Based on the provided document, here's what can be inferred and what information is absent:

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

• Not explicitly provided in the requested comparative "acceptance criteria vs. reported performance" table format. The document lists the standards and guidances that the device was tested against (e.g., ISO 7864, ISO 7886-1, ISO 9626, ISO 23908, ISO 10993 series, USP standards, ASTM standards). It generally states that the device "met" acceptance criteria or "complies with the requirements" of these standards.
• Example from text: "Particulate matter testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria." This implies the acceptance criteria are those defined by USP , and the reported performance was "met" these criteria, but specific quantitative values are not given.
• Example from text: "The safety feature of the proposed device has been validated to verify the prevention function." and "a simulated clinical use study was conducted on the subject device... to evaluate the effect of safety feature per FDA Guidance... The test results demonstrated that the subject device complies with the requirements." This indicates compliance with FDA guidance on sharps injury prevention.

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

• Test Set Sample Size: Not specified for any of the performance tests (e.g., ISO 7864, ISO 7886-1 tests, biocompatibility tests). Standard industrial testing often relies on predefined sample sizes per standard, but these are not enumerated here.
• Data Provenance: The manufacturing entity, Shanghai Kindly Enterprise Development Group Co., Ltd., is based in China. The location where the testing was performed (country of origin of the data) is not explicitly stated, but it's implied to be associated with the manufacturer or their chosen testing labs. The studies are pre-market notification tests to demonstrate substantial equivalence, implying they are conducted for regulatory submission. Whether specific tests were retrospective or prospective is not detailed, but routine device testing for regulatory submission is typically prospective for the purpose of the submission.

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

• Not applicable. The document states "No clinical study is included in this submission." Ground truth, in the context of expert consensus, is typically established for diagnostic or screening devices evaluated in clinical settings, often for image interpretation or diagnosis. This document pertains to a medical device (syringe) where performance is assessed against engineering standards and simulated use.

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

• Not applicable. As there's no clinical study involving human interpretation or subjective assessment, adjudication methods are 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 device is a syringe, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a mechanical device, not an algorithm. Performance tests are inherently "device only" without human-in-the-loop performance in terms of interpretation, but involve human operation for mechanical tasks.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified international (ISO), national (USP, ASTM), and FDA standards/guidances (e.g., ISO 7864 for needle requirements, ISO 7886-1 for syringe performance, ISO 23908 for sharps injury protection, FDA guidance on sharps injury prevention). The device's physical and functional properties are tested against the objective, measurable criteria defined within these standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. No training set exists for this device.

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The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.

KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.

The provided text is a 510(k) summary for a medical device (Sterile Safety Insulin Syringes for Single Use) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the format requested.

The document outlines conformity to various ISO standards and other regulatory requirements but does not detail a specific study with an acceptance criteria table, sample sizes for test/training sets, expert qualifications, or MRMC study results as one might expect for a diagnostic AI/imaging device. Instead, it describes a series of non-clinical tests to verify design specifications and compliance with recognized standards.

Therefore, many sections of your request cannot be directly answered from the provided text.

Here's what can be extracted and inferred:

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

The document lists several ISO standards that the device "complies with" or "conforms to." These standards inherently contain acceptance criteria, and the statement of compliance/conformance indicates that the device met these criteria. However, specific numerical acceptance criteria and reported device performance values are not explicitly stated in a consolidated table format in this document. Instead, compliance with the standard is the reported performance.

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

The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

This type of information is generally relevant for studies involving human interpretation or subjective assessment, particularly in AI or imaging diagnostics. For a non-clinical device like a syringe, "ground truth" is established through physical and chemical testing against defined standards. Therefore, this information is not applicable and not provided in the document.

4. Adjudication method for the test set

Similarly, adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers interpret data that is then arbitrated. This is not applicable to the non-clinical testing of a syringe and therefore not provided.

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

An MRMC study is relevant for evaluating the impact of AI assistance on human performance, typically in diagnostic tasks. This document describes a physical medical device (syringe) and its non-clinical testing. Therefore, an MRMC comparative effectiveness study is not applicable and not performed/reported.

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

This question is also related to AI algorithm performance. As this document concerns a physical syringe, a standalone algorithm performance study is not applicable and not performed/reported. The non-clinical tests served as the "standalone" evaluation of the device's physical properties.

7. The type of ground truth used

For this device, the "ground truth" used for testing would be the specifications and requirements defined by the various ISO standards and USP . This includes physical dimensions, material properties, sterility, particulate matter limits, and biocompatibility criteria.

8. The sample size for the training set

This question is relevant for AI/machine learning models. For the non-clinical testing of a physical medical device, there is no "training set" in the AI sense. This information is not applicable and not provided.

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

Again, this is relevant for AI/machine learning. For this device's non-clinical testing, there is no training set. The "ground truth" for evaluating the device's conformance to standards is established by the scientific and regulatory consensus embodied in the ISO standards and USP monographs themselves. This information is not applicable and not provided.

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

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

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

The document states:

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

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

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