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The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.

The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.

The provided document is a 510(k) summary for the Disetronic Penfine® Insulin Injection Pen Needle, seeking Over-The-Counter (OTC) use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with specific acceptance criteria in the same way a novel device might.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of human subject testing (e.g., patient data). It refers to "Performance data... generated in compliance with existing international standards and protocols." For a device like an injection pen needle, this typically involves bench testing for aspects such as needle strength, flow rate, sterility, penetration force, and compatibility with injection pens.

• Sample Size: Not explicitly stated for bench testing, but would be determined by the relevant international standards and protocols.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data would be generated from lab tests, not human data, so "retrospective or prospective" does not apply in the typical sense.

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 to this 510(k) submission. A 510(k) for a device like an insulin pen needle relies on engineering specifications, material properties, and performance standards, not expert consensus on human-derived data for establishing ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth on image analysis or clinical data. Since the performance data refers to bench testing against standards, human adjudication is not relevant.

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. MRMC studies are used to evaluate diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. The Disetronic Penfine® Insulin Injection Pen Needle is a mechanical medical device, not an AI or diagnostic imaging tool.

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

This information is not applicable. This question pertains to AI algorithms. The Disetronic Penfine® Insulin Injection Pen Needle is a physical medical device.

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

The "ground truth" for this device would be defined by engineering specifications, material standards (e.g., for biocompatibility, sterility), and performance standards for hypodermic needles. For instance, needle sharpness might be "ground-truthed" against a specific force measurement standard, or flow rates against a volumetric standard.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of an AI algorithm or model development for this type of medical device.

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 Disetronic Pen P100 is indicated for the injection of insulin into the body

The Disetronic Pen P100 is a reusable device that provides a method of accurately iniecting a selected dose of insulin from an insulin cartridge supplied by other manufacturers, through a single lumen hypodermic needle. The device can be used by health professionals or for self-iniection by the patient. The device is similar in appearance and size to a ballpoint pen. It is cylindrical in shape and has a retractable dosage knob at the top that resembles the 'clicker' used to extend and retract the tip of a ballpoint pen beyond its housing.

The internal mechanisms used to set and activate the injection are the same across the product line. Each pen operates in the following manner. After the cartridge is loaded into the barrel and the needle is attached, the user pushes a button on the side of the pen opposite the digital display. This releases a spring-loaded 'knob' at the top of the pen. The knob is then rotated in a clockwise direction which increments the digital display to show the dose to be delivered. The needle cap is removed and the needle is inserted into the injection site. The knob at the top of the pen is depressed which advances the plunger to displace the chosen dose. After the injection, the needle is removed from the pen and discarded.

The provided text is a 510(k) summary for the Disetronic Pen P100. This document focuses on demonstrating substantial equivalence to previously marketed devices and does not contain the detailed study information typically associated with acceptance criteria for a novel AI/software device. The device in question is a reusable insulin injection pen, a mechanical device, not an AI, software, or imaging device subject to the types of studies outlined in your request.

Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to aspects that are not relevant to a mechanical device submission like this.

However, I can extract the information that is present and indicate where the requested information is not applicable to this type of device.

Acceptance Criteria and Device Performance for Disetronic Pen P100

Based on the provided 510(k) summary, the "acceptance criteria" are not explicitly defined in a quantitative table with performance metrics as one might expect for a diagnostic or AI device. Instead, the performance is evaluated against a recognized standard for such mechanical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states that the device was "tested using the methods specified in the draft ISO standard, ISO 11608," but does not detail the number of devices or injections tested.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This level of detail is typically not included in a 510(k) summary for a mechanical device conformance to an ISO standard.

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

• Not Applicable. For a mechanical device conforming to an ISO standard, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The performance is assessed against the physical and functional specifications defined in the standard.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, which is not relevant for testing a mechanical injection pen's conformity to an ISO standard.

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 mechanical device, not an AI or diagnostic tool. MRMC studies are used to evaluate diagnostic accuracy and the impact of AI assistance on human reader performance, which is not relevant here.

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.

7. The type of ground truth used

• Standards-based Conformance: The "ground truth" in this context is the requirements and test methods specified in the draft ISO standard, ISO 11608, for "Pen-injectors for Medical Use." The device's performance is measured against these established engineering and functional benchmarks.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set for this mechanical device.

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The device is indicated for the injection of insullin into the body.

The Disetronic Injection Pen is a reusable devices that provides a method of accurately injecting a selected dose of insulin from a fluid cartridge through a single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient. The device is similar in appearance and size to a ball point pen, hence the description. It is cylindrical in shape and has a retractable dosage know at the top that resembles the "clicker" used to extend and retract the tip of a ball point pen beyond its housing.

The internal mechanisms used to set and activate the injection are identical across the oroduct line. Each pen operates in the following manner. After the cartndge is loaded into the barrel and the needle is attached, the user pushes a button on the side of the pen opposite the digital display. This releases a sonng loaded 'knob' at the top of the pen The knob is then twisted in a clockwise direction which increments the digital display to show the dose to be delivered. The needle can is removed and the needle is inserted into the injection site. The 'knob' at the top of the pen is depressed which advances the plunger to displace the chosen dose. After the injection, the needle is removed from the pen and discarded.

The Pen models are differentiated in that different models of pens differ in the amount of drug represented by each incremental click of the dose setting mechanism. These differences are determined by differences in the threaded rod and nut mechanism of each model which determines the distance, and therefore the dose each click of the dosage knob represents.

The provided text describes the Disetronic Injection Pen, which is a reusable device for accurately injecting insulin. The document primarily focuses on its substantial equivalence to previously marketed devices and its conformity with an ISO standard, rather than presenting a detailed study with acceptance criteria and device performance results in the format requested.

However, based on the provided text, we can infer some information relating to the performance data and the study mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The statement refers to "testing using the methods specified in the ISO standard," which implies that the testing was conducted in accordance with the standard's guidelines, but specific details are not provided.

3. Number of Experts and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set. The validation primarily relies on conformance to an ISO standard.

4. Adjudication Method

There is no mention of an adjudication method as the evaluation is based on conformance to a technical standard rather than subjective assessments by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission focuses on device performance against an engineering standard, not human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states, "The device conforms with the requirements when tested using the methods specified in the ISO standard, ISO 11608-1, 'Pen-injectors for Medical Use - Part 1. Requirements and Test Methods.'" This indicates a standalone assessment of the device's functional performance against established technical specifications.

7. Type of Ground Truth Used

The ground truth used is conformance to the technical specifications and test methods outlined in ISO 11608-1, "Pen-injectors for Medical Use - Part 1. Requirements and Test Methods." This is a regulatory/standard-established ground truth for device functionality and safety.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of submission (510(k)) for a medical device generally focuses on validation and performance testing, not on machine learning model training.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of machine learning, there is no information on how its ground truth was established. The focus is on the device's compliance with established engineering standards.

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The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injector pen.

The 31 gauge Disetronic PenFine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness of the cannula.

The provided text describes a 510(k) submission (K982399) for a 31 gauge Disetronic PenFine® injection Pen Needle. This is a medical device, specifically a hypodermic single lumen needle, and the submission focuses on demonstrating substantial equivalence to existing predicate devices, not on proving new clinical performance. Therefore, many of the typical acceptance criteria and study details for AI/device performance are not applicable here.

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

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

For a medical device like this, acceptance criteria typically involve demonstrating safety and effectiveness by meeting engineering specifications, biocompatibility standards, and functional requirements comparable to predicate devices. The document doesn't provide a table of specific numerical acceptance criteria from the submission. Instead, the "performance" demonstrated is substantial equivalence to legally marketed predicate devices based on design and functional testing.

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 a "test set" in the context of clinical performance data involving patient samples or diagnostic accuracy. The performance data mentioned refers to engineering and functional testing. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for such a "test set."

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

This is not applicable. The submission is for a physical medical device (injection pen needle), not a diagnostic algorithm or AI system that requires expert-established ground truth on a test set of data.

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

This is not applicable. There is no "test set" in the context of evaluating diagnostic performance or classifying data points for ground truth.

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. MRMC studies are used for evaluating diagnostic imaging systems or AI systems that assist human readers. This submission is for an injection pen needle.

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

This is not applicable. This device is an injection pen needle, which is a physical medical device, not an algorithm.

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

This is not applicable. For a physical device like an injection pen needle, "ground truth" would relate to its physical properties, sterility, and functional performance, verified through laboratory testing and engineering standards, not through methods like expert consensus on medical images or pathology results.

8. The sample size for the training set

This is not applicable. There is no "training set" for an injection pen needle. The device is manufactured based on design specifications and quality control.

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

This is not applicable. As there is no training set, there is no ground truth for it to be established.

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The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.

The Disetronic PenFine® Injection Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens. They will be offered with a 29 and 30 gauge needle in an 8, 10 and 12 mm length.

The PenFine® Pen Needle is comprised of a siliconized stainless steel cannula welded into in a polyethyleneterapthalate (PETP) hub. A polyethylene protective cap snaps onto the hub over the needle. This assembly fits into a K-Resin outer protective container which provides the sterile barrier along with the peel tab.

The PenFine® has a patented design feature that differs from currently available pen needles. Existing pen needles must be screwed onto the threaded male extension of the injection pen. The PenFine® uses a single motion "snap on" mechanism.

The needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the Injection Pen. The back end of the cannula punctures the rubber injection port on the drug reservoir in the Injection Pen. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected.

When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The Injector Pen automatically delivers the drug through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

This document is a 510(k) summary for the Disetronic PenFine® Injection Pen Needle. It establishes substantial equivalence to existing predicate devices but does not provide a study to prove acceptance criteria. Instead, it relies on "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." Therefore, many of the requested fields cannot be filled.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states: "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the acceptance criteria are met by virtue of being equivalent to existing, approved devices and conforming to standards, but the specific criteria and their measured performance are not detailed.

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

Not provided. The document only vaguely mentions "Performance data has been generated".

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 type of device (injection pen needle) does not typically involve expert review for "ground truth" in the way a diagnostic imaging device would. Performance is typically assessed through engineering tests and adherence to 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

Not applicable. This device is a pen needle, not an AI-powered diagnostic tool.

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

Not applicable. This device is a pen needle, not an algorithm.

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

Not explicitly stated or applicable in the traditional sense for this device. Performance would likely be measured against engineering specifications, biocompatibility standards, and sterility testing, rather than a clinical "ground truth." The "ground truth" in this context is adherence to established standards for mechanical performance, sterility, and material safety.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model.

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

Not applicable. This device is a physical medical device, not a machine learning model.

Summary of what is provided in the document regarding validation:

The document relies on "design equivalency and the functional and safety testing" to establish substantial equivalence to predicate devices (Novo Nordisk NovoFine 30 Injection Pen Needles and Becton Dickinson B-D Micro-Fine, Ultra-Fine and Ultra-Fine II Injection Pen Needles).

The core of the "proof" for this device's acceptance seems to be:

• Comparison to Currently Marketed Devices: The Disetronic PenFine® Injection Pen Needles are stated to be substantially equivalent to established products on the market.
• Technological Characteristics: The document claims "The technological characteristics are the same as the predicate devices."
• Performance Data: It broadly states that "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the device was tested against relevant industry standards (e.g., for needle sharpness, sterility, flow rates, compatibility with pens, material safety) and met the requirements, thus demonstrating equivalency to already approved devices.

In essence, this 510(k) summary indicates that the device meets acceptance criteria by demonstrating conformance to established standards and substantial equivalence to existing, approved devices, rather than through a novel clinical study with explicit acceptance metrics and performance results. Specific numerical performance metrics or detailed study methodologies are not included in this summary.

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