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TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

The TopFine® LDS (Low Dead Space) Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.

The proposed device has 2 models depending on the diameter of the needle.

The provided document is a 510(k) premarket notification for a medical device, specifically a syringe. It does not contain information about an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, it is not possible to describe acceptance criteria or a study related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence of the "TopFine® LDS (Low Dead Space) Syringe" to a predicate syringe through various performance tests and material comparisons.

Here's an analysis based on the information provided, specifically addressing the technical performance of the syringe, not AI/ML:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Syringe)

The document details various performance criteria for the syringe. There isn't a single table explicitly labeled "Acceptance Criteria and Reported Device Performance" with detailed numerical results for each criterion. However, the "Comparison of technological characteristics with the predicate device" section (page 5) and "Performance data" section (page 7) implicitly define the acceptance criteria by stating compliance with recognized standards and providing general results.

Here's an attempt to construct a table based on the provided information, focusing on criteria where reported performance is available, even if only generally stated as "Same" or "Complies."

Since this is concerning a non-AI/ML medical device, the following points are not applicable or cannot be answered from the provided text:

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 exact sample sizes for each physical or biological test. It only mentions that tests were "conducted."
   • Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing 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)

   • Not applicable as this is not an AI/ML device requiring expert ground truth for image/data interpretation. This refers to standard performance testing.

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

   • Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or AI/ML output.

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. "Clinical studies were not required to support substantial equivalence."

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 the syringe, "ground truth" would be established by direct physical measurements, chemical analyses, and biological assays according to the specified international and national standards (e.g., ISO, USP, ASTM). For example, the "dead space" measurement itself would be the ground truth for that specific characteristic, and the acceptance criterion is a predefined maximum value (≤ 0.03 ml).

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. This is not an AI/ML device.

In summary, the document addresses a traditional medical device (syringe) and demonstrates its substantial equivalence to a predicate device through adherence to manufacturing standards, material comparisons, and performance testing against established physical, chemical, and biological criteria, rather than through AI/ML performance metrics.

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Autokeeper® Safety Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Not Found

This FDA letter is a 510(k) clearance for the Autokeeper® Safety Pen Needle. It primarily addresses regulatory compliance and substantial equivalence to a predicate device. It does not contain a detailed study report or acceptance criteria for device performance as would be found in a clinical study or detailed engineering report.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from the provided text. This document is a regulatory approval letter, not a scientific study report.

To provide the requested information, a different document, such as a summary of safety and effectiveness data or a clinical study report, would be necessary.

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Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.

Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

The document provided describes the Top Fine® Pen Needle and its equivalence to a predicate device (Feel Fine Insulin Pen Needle). The acceptance criteria are based on bench testing to demonstrate equivalent performance to the predicate device.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Notes:

• The document explicitly states that the "principal device demonstrated equivalent performance to the predicate devices during bench testing" and that "The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864." The general conclusion statement also implies compliance for other aspects.
• For several criteria, specific numerical acceptance limits are not provided in the document, but compliance with the standards (ISO 11608-2, ISO 7864, ISO 11135, USP 39, KP 11) serves as the acceptance criteria.

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

• Sample size for the test set: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench tests" being conducted.
• Data provenance: The tests were conducted by MedExel Co., Ltd. in Korea (company address listed as "252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea"). The nature of bench testing implies the data would be prospective for the device being tested.

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

Not applicable. The "ground truth" for a medical device like a pen needle typically refers to its physical and functional performance against established engineering and medical standards, not expert opinions or diagnoses. The "bench tests" are designed to objectively measure these parameters.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation relies on objective measurements against engineering and medical standards, not subjective expert judgment requiring 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 a hypodermic single lumen needle, not an AI-powered diagnostic tool. Therefore, MRMC effectiveness studies with human readers and AI assistance are not relevant to its evaluation.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is evaluated through physical and functional bench tests.

7. The type of ground truth used

The ground truth used is based on established engineering and medical device standards and objective physical and functional performance measurements. Specifically, the document mentions:

• ISO 11608-2:2012 (Needle systems for medical use - Part 2: Needles for pen injectors)
• ISO 7864:1993 (Sterile hypodermic needles for single use)
• ISO 11135: 2007 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices)
• USP 39: Bacterial Endotoxin test
• KP 11: Endotoxin Test Method

8. The sample size for the training set

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

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

Not applicable. There is no training set for this type of device.

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