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Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.

I am sorry, but the provided text from the FDA 510(k) summary for the NovoFine® Plus does not contain the specific information required to answer your request regarding acceptance criteria and a study proving a digital health device meets acceptance criteria.

The document is for a hypodermic single lumen needle (NovoFine® Plus), which is a physical medical device, not a digital health device or an AI/software as a medical device (SaMD). Therefore, the concepts of "acceptance criteria" and "study types" as you've described them (e.g., sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable or detailed in this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on:

• Intended Use, Indications for Use, and Basic Design: Stating they are the same as the predicate.
• Technological Characteristics: Primarily noting the difference in needle gauge size (29G vs. 32G) and asserting that this difference does not introduce new risks.
• Performance Testing: Mentioning compliance with ISO standards (ISO 9626 for material/dimensions and ISO 11608-2 for performance) to verify the design against established requirements for such physical devices.
• Biocompatibility: Confirmation that the new needle meets the same biocompatibility standards as the predicate.

There is no mention of AI, algorithms, or any form of digital health technology that would necessitate the kind of performance studies or ground truth establishment you are asking about.

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NovoFine® needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

NovoFine® is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.

This document is a 510(k) premarket notification for the NovoFine® hypodermic single lumen needle, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K173479).

Based on the provided text, there is no information regarding acceptance criteria for a device's performance that would typically be measured through sensitivity, specificity, accuracy, or other similar metrics. This document is for a medical device (hypodermic needle), and the "performance" discussed relates to its mechanical and material properties, rather than diagnostic accuracy or algorithmic performance.

Therefore, the following information cannot be extracted from the provided text, as it describes a different type of evaluation:

1. A table of acceptance criteria and the reported device performance (in terms of clinical outcomes or diagnostic metrics).
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Instead, the document details non-clinical performance testing to demonstrate the device's physical and material properties meet established standards, thereby supporting its substantial equivalence to a predicate device.

Here's the relevant information that can be extracted concerning the device's characteristics and testing:

Device Acceptance Criteria and Performance (Non-Clinical/Engineering):

The document describes material and mechanical specifications that the device must meet, demonstrating its substantial equivalence to the predicate device. These are more akin to engineering specifications rather than clinical performance metrics.

Study Information (Non-Clinical/Engineering):

• Non-Clinical Tests Performed: The device underwent non-clinical performance testing to support the determination of substantial equivalence.
• Testing Standards:
  • ISO 10993-1: 2018 (Biological evaluation of medical devices)
  • DS EN/ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)
  • ISO 11608-2: 2012 (Needle-based injection systems for medical use)
  • ISO 9626: 2016 (Stainless steel needle tubing for the manufacture of medical devices)
  • Particulates per ISO 11040-4:2015 (Prefilled syringes)
  • ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices for shelf-life validation)
• Biocompatibility Tests: In vitro cytotoxicity, intracutaneous reactivity, skin sensitisation, acute systemic toxicity, and haemocompatibility (haemolysis).
• Functional Compatibility: Tested with a list of pen injectors (e.g., Autopen® 24, FlexPen®, Ozempic®, etc.) to demonstrate connectivity and maintenance of dose accuracy.
• Package Integrity Testing: Conducted after environmental conditioning and simulated transportation in accordance with ISTA 3A, on final, packaged, and sterile devices.

The document does not describe a clinical study measuring diagnostic performance or AI algorithm effectiveness, as it pertains to a physical medical device.

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Indications for Use: NovoFine® Plus 32 G 4 mm needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

NovoFine® Plus 32 G 4 mm needle is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional.

After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.

The provided document is a 510(k) premarket notification for a medical device, the NovoFine® Plus 32G 4 mm needle, and details why it is substantially equivalent to a previously cleared predicate device (NovoFine® Plus 32G 4 mm ETW cleared under K133738). This type of submission focuses on demonstrating equivalence rather than establishing new performance criteria for novel devices.

Therefore, the document does not contain information about acceptance criteria for a novel device, nor a study proving a device meets such criteria. Instead, it focuses on demonstrating that minor changes to an existing, already cleared device do not introduce new safety or effectiveness concerns, and that the updated device performs similarly to the predicate.

Here's an analysis of the provided text in relation to your request:

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

   • Not Applicable. The document provides a "Side by side comparison of the subject device and predicate device" (Table 1 on page 7). This table compares specifications like outer diameter, inner diameter, length, gauge, and material composition between the current device (K202005) and the predicate device (K133738). It also lists existing standards that apply to both. However, these are device specifications and standards compliance for an equivalent product, not new acceptance criteria established for a novel device and corresponding performance data from a specific study against those criteria.
   • For example, it states "Inner diameter: Minimum 0.146 mm" for the subject device and "0.145-0.16 mm" for the predicate. This is a specified parameter, not an acceptance criterion with a calculated performance output from a study.

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 states "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards" (page 8). It also mentions "functional compatibility according to ISO 11608-2:2012 with all leading pen injectors available on the market." However, it does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

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 question typically pertains to studies involving expert review for diagnostic or screening devices where a "ground truth" is established by human experts (e.g., in medical image analysis). The NovoFine® Plus is a hypodermic needle; its performance is assessed through engineering and biocompatibility testing against established standards, not expert-adjudicated clinical outcomes.

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

   • Not Applicable. As explained above, this device and its clearance process do not involve expert adjudication methods typically seen in AI/diagnostic device studies.

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 device for drug delivery, not a diagnostic or AI-assisted interpretation device, so MRMC studies are not relevant.

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, so "standalone algorithm performance" is not relevant.

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

   • Not Applicable. The "ground truth" for this device's performance would be compliance with manufacturing specifications, established engineering standards (like ISO 11608-2:2012 for needle-based injection systems, and ISO 10993-1 for biocompatibility), and functionality testing (e.g., flow rate, bond strength, sterility). This is not typically referred to as "ground truth" in the context of clinical outcomes or expert consensus.

8. The sample size for the training set

   • Not Applicable. This is a physical device, not an AI model, so there is no "training set."

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

   • Not Applicable. As above, there is no "training set" or corresponding ground truth establishment process for this type of device.

In summary, the provided document is a 510(k) submission for substantial equivalence of a hypodermic needle. It describes product specifications and compliance with established ISO standards, but it is not a study that establishes new acceptance criteria for a novel device or provides detailed performance data against such criteria in the way your request outlines for AI or diagnostic devices. The closest information available is the comparison table of specifications between the subject device and the predicate device, implying that the acceptance criteria are met by conforming to these specifications and relevant ISO standards.

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The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.

The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.

The provided text describes a 510(k) premarket notification for the NovoPen Echo®, specifically to expand its approved use to include Fiasp® (insulin aspart injection) 3mL PenFill® cartridges. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K162602) rather than presenting a standalone study of the device's diagnostic or therapeutic performance in a clinical setting.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this regulatory document. This document is about a device's safety and performance in delivering a drug, not about its diagnostic accuracy or establishing a new therapeutic effect.

Here's the information that can be extracted or reasonably inferred from the document:

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

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

• Sample Size: Not explicitly stated for the dose accuracy performance test. ISO11608-1:2014 would specify the number of individual tests (e.g., number of pens tested, number of doses per pen) required for compliance. This document only states that the testing was performed and met the standard.
• Data Provenance: Not specified, but generally, such performance tests are conducted by the manufacturer (Novo Nordisk) in a controlled laboratory environment. It is not clinical data, so terms like "retrospective or prospective" or "country of origin of the data" are not applicable in this context.

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 a mechanical device's dose accuracy is typically established by precision measurement equipment (e.g., gravimetric or volumetric methods) in an engineering or metrology lab, not by human experts, and certainly not by medical experts for diagnostic purposes.

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

• Not applicable. This concept applies to human interpretation of diagnostic data where a consensus among experts is needed. For mechanical performance testing, the results are objectively measured.

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 medical device for insulin delivery, not an AI-assisted diagnostic tool or a system involving human readers/interpreters in a diagnostic context.

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

• Not applicable in the sense of an algorithm for diagnosis or interpretation. The device itself operates mechanically. The "standalone" performance here refers to the device's ability to accurately deliver insulin doses, which was tested.

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

• The "ground truth" for device performance (dose accuracy) would be the precisely measured volume or weight of liquid dispensed, determined using calibrated laboratory equipment according to the methods outlined in ISO11608-1:2014.

8. The sample size for the training set

• Not applicable. The NovoPen Echo® is a mechanical device, not an AI/ML algorithm that requires training data.

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

• Not applicable for the reason above.

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NovoFine® 32 G Tip (0.23/0.25) X 6 mm ETW needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, semaglutide and somatropin.

NovoFine® 32 G Tip (0.23/0.25) 6 mm ETW needle is designed for single use. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, a new disposable needle must be used.

The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that "No physical change has been made from K062500 cleared on November 21, 2006 and K090111 cleared on February 1, 2010. The only change was to include an additional drug name in the indication for use statement."

Therefore, the "acceptance criteria" discussed are largely in reference to functional compatibility with the new drug (semaglutide) and adherence to existing standards, rather than new performance-based acceptance criteria for the needle itself.

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

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

The document doesn't explicitly state "acceptance criteria" in a separate table for the device performance as a whole. Instead, it compares the current device to predicates based on established specifications and reports that functional compatibility tests were performed against an ISO standard.

For the functional compatibility with the semaglutide pen-injector, the acceptance criteria are implicit in the ISO 11608-2:2012 standard and the specific parameters tested:

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

• Sample Size for Functional Compatibility (Semaglutide): 120 pen needles for each pen-injector variant tested. This means 120 pen needles were tested with Variant 1 and 120 with Variant 3.
  • (60 pen needles subsequent to low dose and 60 pen needles subsequent to high dose for each variant).
• Data Provenance: Not explicitly stated, but implies prospective testing conducted by Novo Nordisk (or a contracted lab) as part of the design verification for the 510(k) submission. No country of origin for data is specified, but the manufacturing sites are Nipro Medical Industries Ltd, Japan and Nipro Corporation Ltd, Thailand, which may imply where some testing could have occurred.

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 information is not applicable to this type of device and study. The testing involves objective physical measurements and adherence to international standards (ISO), not expert consensus on medical images or diagnoses.

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

• This information is not applicable. The testing involves objective physical measurements and adherence to international standards (ISO), not subjective interpretations 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

• This information is not applicable as the device is a hypodermic needle, not an AI-powered diagnostic or assistive tool.

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

• This information is not applicable as the device is a hypodermic needle, not an algorithm.

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

• The "ground truth" for the device's substantial equivalence and performance revolves around objective physical measurements compared against international standards (ISO 11608-2:2012 for pen-needles, ISO 10993 series for biocompatibility, ISO 11135-1:2014 for sterilization) and established internal specifications of the predicate device.

8. The sample size for the training set

• This information is not applicable. The device is a physical medical device (hypodermic needle), not a machine learning algorithm requiring a 'training set'. The "training" data refers to the historical data and performance of the predicate device.

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

• This information is not applicable for the reasons stated above. The "ground truth" for the predicate device would have been established through its own rigorous testing and adherence to standards at the time of its initial clearance (K062500 and K090111). The current submission relies on the fact that the physical design is identical to these previously cleared devices.

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The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the seff-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.

The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.

The provided document is a 510(k) Special Summary for the NovoPen Echo®, a reusable pen injector for insulin. It describes the device, its intended use, and the rationale for claiming substantial equivalence to predicate devices.

However, the document does not contain information about an AI/Algorithm-based diagnostic or prognostic device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details (test set, ground truth experts, adjudication, MRMC, standalone performance), or training set specifics as this type of information is not relevant to the described device.

The document states:

• "No clinical testing was provided or required." (Page 5)
• The performance testing was device verification tests to ensure compliance with ISO11608-1 "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems." (Page 4)

Therefore, the requested details about an AI study (sample sizes, expert consensus, MRMC, training sets) are not applicable to the content of this 510(k) submission.

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The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) finsulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.

The NovoPen Echo® (STJ) is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] . The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injector for the injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected. The pen-injector is intended for use with PenFill® 3 mL cartridge of NovoLog", 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] and a single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk ).

The provided document is a 510(k) summary for the NovoPen Echo® device, specifically for a change in manufacturing location and minor updates to the device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a de novo study with novel acceptance criteria and reported device performance from a new efficacy trial.

Therefore, the document does not contain the detailed information necessary to fully address all points concerning acceptance criteria and study design as typically expected for a new device's efficacy study.

However, based on the available information, here's what can be extracted and inferred:

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

The document states that the device was evaluated against the requirements specified in ISO 11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems. This standard would define the acceptance criteria for performance aspects such as dosing accuracy, dose button force, and other functional parameters relevant to pen injectors.

While specific numerical acceptance criteria and reported performance values are not provided in this summary, the document states:

• "Device Verification Tests were run to verify all product requirements are still met and all changes work properly and complies with the requirements specified in ISO11608-1:2012"
• "Software verification and validation regression testing all static, unit, integration and system, tests as well as additional tests for the changes and related risk control measures was conducted and all tests passed."
• "In conclusion, the results of the testing demonstrate that NovoPen Echo® (STJ) is as safe and effective and performs as well as the predicate device."
• "The results of the testing to standards provide additional evidence that NovoPen Echo® (STJ) is substantially equivalent to the predicate device, NovoPen Echo® (DMD)."

Therefore, the implied acceptance criteria are compliance with ISO 11608-1:2012 and the reported device performance is that it met all product requirements and passed all tests, demonstrating substantial equivalence to the predicate device.

Without the full test reports, a detailed table with specific numerical criteria and results cannot be generated from this summary.

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

• Sample Size: Not specified in the summary.
• Data Provenance: The tests were conducted to support the transfer of manufacturing from Denmark (DMD) to Tianjin, China (STJ), implying the testing was performed on devices produced at the new manufacturing site. The study is prospective in the sense that newly manufactured devices were tested to confirm performance.

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 type of information is not applicable to the type of device (pen injector) and the nature of this submission (manufacturing change). Ground truth for a pen injector's functional performance would typically be established through engineering measurements and adherence to international standards, not through expert consensus on diagnostic images or similar expert review processes.

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

Not applicable for this type of device and submission. Adjudication methods are typically used in studies involving subjective interpretation (e.g., medical imaging) to resolve disagreements among human readers.

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. The NovoPen Echo® is a mechanical pen injector designed for patient self-injection, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is typically relevant for AI/software devices. The NovoPen Echo® is a mechanical device with a memory function and liquid crystal display; its "memory function" is described as a sensor detecting movement for display, not a complex algorithm performing diagnosis or analysis. The performance verified was related to the mechanical and display functionalities, meaning a form of "standalone" evaluation of the device's technical specifications was performed according to ISO standards.

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

The "ground truth" for the device's performance is objective measurement against the specifications and requirements outlined in ISO 11608-1:2012 and potentially internal product requirements for dose accuracy, delivery force, functionality of the display, etc. This is based on engineering and physical measurement standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is not an AI-driven learning algorithm that requires a training set.

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

Not applicable (as per point 8).

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NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.

NovoFine® Plus needles are single use, sterile need in conjunction with pen injector devices. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Use the needles as described in the instructions for use that comes with the pen-injector device and as instructed by the healthcare professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NovoFine® Plus 32G x 4 mm Disposable Needle:

This document is a 510(k) summary for a medical device cleared via substantial equivalence. As such, it does not detail a study to "prove the device meets acceptance criteria" in the way one might expect for a novel device undergoing clinical trials to establish efficacy. Instead, it demonstrates that the device is as safe and effective as a legally marketed predicate device through non-clinical testing and comparison of technological characteristics. Therefore, many of the typical acceptance criteria and study details for an AI/algorithm-based device outlined in your prompt are not applicable here.

However, I will extract the relevant information where possible, and explicitly state when a particular detail is not available or not applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "The needle samples tested are manufactured..." and "The NovoFine® Plus 32G 4 mm needles are subjected to a final design verification test." This implies a sample was tested for engineering and performance characteristics, but the size is not specified.
• Data Provenance: The device was developed and tested by Novo Nordisk R&D. The testing was non-clinical, involving laboratory and engineering tests against international standards. The origin of "data" in the sense of patient data is not applicable, as this is a device and not an AI or diagnostic algorithm which would use patient data.

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

Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant for a hypodermic needle. The "ground truth" here is compliance with established engineering and biocompatibility standards, and functional performance, which is determined through laboratory testing by specialized personnel (e.g., engineers, quality control staff).

4. Adjudication Method for the Test Set

Not applicable. This is not an observational or diagnostic study requiring expert adjudication of results. Compliance is determined by objective measurement against standard 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

Not applicable. This device is a hypodermic needle, not an AI or diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This device does not have an algorithm and is not a standalone diagnostic or AI tool. Performance is inherently "standalone" in the sense that the needle's physical characteristics and function are tested without a human "reading" or "interpreting" its output beyond using it for its intended purpose.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptance is its compliance with international and domestic consensus standards (e.g., ISO 11608-2, ISO 10993-1, ISO 11607-1, ASTM F1980) and its demonstrated functional performance in non-clinical laboratory tests. Additionally, the concept of substantial equivalence to existing, legally marketed predicate devices forms a key part of the "ground truth" for its regulatory clearance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the AI sense.

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

Not applicable. See point 8.

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The NovoPen Echo* is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses Penli ill " 3 mL cartridges of Novo Nordisk insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in half unit increments, from a Novo Nordisk 3.0 mL insulin cartridge. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected. The pen-injector is intended for use with Novo Nordisk 3.0 mL insulin cartridges and single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk).

The provided text describes the NovoPen Echo® insulin delivery device and its 510(k) summary. However, it does not contain the detailed acceptance criteria and study information as requested. The document states that the device meets design requirements and complies with ISO 11608-1, and that Human Factor testing documented its safety. It also mentions a shelf life.

Here's a breakdown of what is present and what is missing from your request:

What is present (to a limited extent):

• Acceptance Criteria Mention: The document states that "The results of design verification testing has documented that the NovoPen Echo® meets all its design requirements and complies with the requirements specified in ISO 11608-1 Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods." This implies that the acceptance criteria are based on ISO 11608-1, but the specific numerical criteria or performance targets are not listed. It also mentions that "Human Factor testing has documented that the NovoPen Echo" is safe to use."
• Study Mention: "Design verification testing" and "Human Factor testing" are mentioned as studies performed.
• Device Performance Mention: It states the device "meets all its design requirements and complies with the requirements specified in ISO 11608-1" and "is safe to use." Specific performance metrics are not given.

What is largely missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The text mentions meeting ISO 11608-1, but doesn't detail the requirements from that standard or the specific performance results in a table format.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific "test set" or "ground truth" derived from experts for performance metrics is detailed. The human factors testing likely involved users, but specifics are absent.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is a medical device (insulin pen), not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device.
7. The type of ground truth used: Not applicable for device performance in the context of ISO standards. For human factors, "safety" is the ground truth, assessed by user interaction.
8. The sample size for the training set: Not applicable for a mechanical device.
9. How the ground truth for the training set was established: Not applicable for a mechanical device.

Table of Acceptance Criteria and Reported Device Performance (Based only on the provided text, heavily inferred):

In summary, the provided 510(k) summary is a high-level document confirming that testing was done and the device met requirements set by an international standard (ISO 11608-1) and human factors principles. It does not elaborate on the specific details of those tests, such as sample sizes, ground truth establishment methods, or the specific numerical performance results.

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NovoTwist® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin.

NovoTwist® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices built with bayonet coupling. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then pressed onto the injection delivery device with a bayonet coupling and twisted a quarter of a revolution until tightness and a confirmatory click is heard. Then the outer and inner caps of the needle are removed. Injection is performed by following the procedure described in the User Manual provided with the pen injection device and instructions from your health care professional. After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used. Function checks for the delivery device can be performed with the NovoTwist® needles by using the needle cap. The NovoTwist® needle is used in exactly the same manner as the NovoFine® and the BD Pen needle except it is built with an improved attachment mechanism. NovoTwist® needle is attached to the delivery device via a bayonet thread. This allows the user to press down and twist the needle a quarter of a revolution instead of tightening through several revolutions as with the NovoFine® needle, BD pen needle, and many other commercially marketed hypodermic needles that operate on the same principles. This improved mechanism is intended to reduce the attachment time. In addition, users can hear a confirmatory click when the NovoTwist® needle is attached correctly to the device. This user friendly feature is designed to ensure the needle is attached to the device correctly before beginning the injection.

NovoTwist® Needle Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) summary for the NovoTwist® needle, claiming substantial equivalence to existing predicate devices. It references compliance with several ISO standards and outlines specific non-clinical tests. However, it does not explicitly state specific pass/fail acceptance criteria (e.g., "bubble leak rate must be less than X%") nor does it present quantitative results for how the device performed against these criteria. Instead, it generally states that the tests support the device meeting "specified requirements" and being "safely used."

Therefore, the table below reflects what is implied as acceptance for specific tests and the general statement of performance:

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

• Sample Size for Test Set: The document states that the final design verification test involved "34 mechanical and visual tests" but does not specify the exact number of NovoTwist® needles tested for each of these tests. It only mentions that "The needle samples tested are manufactured, sterilized, packaged and labelled on validated equipment and QA-released in accordance with cGMP..."
• Data Provenance: The document implies the tests were conducted by "Novo Nordisk R&D" and that "The needle samples tested are manufactured...in accordance with cGMP for Medical Devices (ISO 13485:2003 Medical devices - Quality management systems Requirements for regulatory purposes)." This suggests the data is prospective and likely originated from internal company testing, presumably in facilities compliant with quality management systems. The country of origin for the data is not explicitly stated, but Novo Nordisk is a Danish multinational company.

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

This information is not applicable as the described tests are non-clinical (mechanical, visual, sterility, biocompatibility, shelf-life, handling, and usability) and do not involve human assessment of medical images or patient outcomes that would require expert ground truth establishment in the traditional sense (e.g., by radiologists). The "ground truth" for these tests would be defined by the technical specifications and standards (e.g., ISO 11608-2) the device is being tested against.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective, physical, or chemical measurements/inspections against predefined specifications or standards. They do not involve subjective assessments requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests are required." The submission relies on non-clinical testing and substantial equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device, NovoTwist® needle, is a physical medical device (hypodermic needle), not a software algorithm or AI-powered system where a "standalone" algorithm-only performance would be relevant.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and internal specifications. For example:

• ISO 11608-2:2000 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
• ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
• ISO 7864:1993 (Sterile hypodermic needles for single use)
• ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
• Internal design specifications for mechanical, visual, and functional performance.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device (hypodermic needle), there is no "training set" in the context of machine learning or artificial intelligence. The development process involves prototype testing and design verification, not algorithm training.

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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