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FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. . The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) The needle cap covers intended to provide physical protection to the needle tube.

The provided text describes a 510(k) premarket notification for a disposable hypodermic needle named FEELject NEEDLES, seeking substantial equivalence to a predicate device. The information focuses on the regulatory submission process and general device characteristics, not on a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested sections about a detailed study simply cannot be filled from the provided text.

Here's what can be extracted and what information is missing:

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

Missing Information:

• Specific quantitative limits or thresholds for "acceptance criteria" for biocompatibility, sterility, or pyrogenicity are not provided. The document only states that tests were performed and the device passed or met the requirements.
• Detailed performance metrics or quantitative results for fluid injection/aspiration are not provided. The phrase "performs in a substantially equivalent manner" is used.

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

Missing Information:

• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned.

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 / Missing Information:

• This type of expert-driven ground truth establishment is typically relevant for diagnostic or image-analysis devices. For a hypodermic needle, "ground truth" would be objective measurements and qualitative assessments from bench testing and manufacturing standards, not expert adjudication in the same sense.
• No experts are mentioned as being involved in establishing ground truth for the performance tests.

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

Not Applicable / Missing Information:

• Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, often in clinical trials or image reading studies. This is not relevant for the type of bench testing described for a hypodermic needle.

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 / Missing Information:

• An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a hypodermic needle, and no AI component or human interpretation study is mentioned.

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

Not Applicable / Missing Information:

• This refers to AI algorithm performance. The FEELject NEEDLES is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the performance described, the ground truth would be based on standardized test methods and specifications for medical devices, specifically hypodermic needles. This includes established physical, chemical, and biological test methods to assess properties like biocompatibility, sterility, pyrogenicity, and mechanical integrity (e.g., sharpness, flow rate, hub-needle bond strength). The document implies adherence to these standards to achieve substantial equivalence.

Missing Information:

• Specific details of these standards or how individual ground truth values were established for each test are not provided.

8. The sample size for the training set

Not Applicable / Missing Information:

• Training sets are for machine learning algorithms. This device is a physical hypodermic needle, not an AI model.

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

Not Applicable / Missing Information:

• As above, training sets are not applicable to this device.

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These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

This response is based on the provided text only and does not include external information.

The document describes the Feel Fine Insulin Pen Needle and its substantial equivalence to a predicate device, the B.Braun "one.clickTM needle" (K033575). It does not provide detailed acceptance criteria with specific numerical performance metrics or a comprehensive study report with quantitative results for the Feel Fine Insulin Pen Needle. Instead, it indicates that the device's safety and effectiveness were demonstrated through bench tests.

Here's an analysis of the information available against your requested criteria:

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

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

The document does not specify the sample size used for any of the bench tests (biocompatibility, mechanical, sterility). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests.

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

This information is not provided. The document refers to "bench tests" for performance evaluation, not clinical studies involving expert assessment of outcomes or images for establishing ground truth in the context of diagnostic devices.

4. Adjudication method for the test set

This information is not provided. As the tests are described as "bench tests" for engineering and material properties, an adjudication method in the context of clinical interpretation would likely not be applicable.

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 comparative effectiveness study was not conducted. This device is an insulin pen needle, a physical medical device for injection, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This information is not applicable. The Feel Fine Insulin Pen Needle is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth for the "performance" of the pen needle was established through "bench tests" for properties like biocompatibility, mechanical integrity, and sterility. These are typically assessed against pre-defined engineering and material standards, rather than expert consensus, pathology, or outcomes data in a clinical trial setting. The "ground truth" here refers to compliance with these standards and equivalence to the predicate device's established performance.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm, and therefore does not have a "training set" in the AI context.

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

This information is not applicable for the reasons stated in point 8.

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The Feel-tech disposable sterile insulin syringes are intended for injection of U100 insulin only.

The Feel-ject insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

The provided text describes a 510(k) premarket notification for the Feel-ject Insulin Syringe. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than focusing on novel device performance metrics or studies in the way an AI/ML medical device might. Therefore, many of the requested categories are not directly applicable or reported in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for biocompatibility tests, deflection limits for mechanical tests, sterility assurance levels) are not provided in this summary. The assessment is qualitative, relying on "as safe, as effective, and performs in a substantially equivalent manner" to the predicate device.

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

This information is not provided in the document. The text mentions "Bench tests were performed" but does not detail the sample sizes for these tests or the data provenance. These are physical product tests, not analyses of data sets in the context of AI/ML.

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

This information is not applicable/provided. For a physical medical device like an insulin syringe, "ground truth" is typically established through adherence to pre-defined engineering and quality standards, not expert labels on a dataset. The document refers to "bench tests" to demonstrate equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in AI/ML performance studies where expert consensus is needed. For bench testing of a physical device, the results are typically objectively measured against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An insulin syringe is a physical device, not an AI/ML algorithm that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant to this product.

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

This information is not applicable. This is a physical, non-AI medical device. There is no algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to established engineering standards, biocompatibility requirements, and sterility standards, demonstrating equivalence to a legally marketed predicate device (UltiCare™ Disposable Syringes and Needles K062702). This is verified through objective "bench tests" rather than expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device does not involve a "training set" in the context of AI/ML.

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

This information is not applicable/provided. As above, there is no "training set" for this physical device.

In summary, the provided document for the Feel-ject Insulin Syringe is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device through bench testing of physical characteristics and compliance with manufacturing standards, rather than the type of performance study for an AI/ML medical device many of the questions are geared towards.

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