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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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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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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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For use in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.

The NovoFine® 32G Tip needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle outer and inner caps are removed. Prepare for injection by following the procedure described in the instruction leaflet 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 local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine® 32G Tip by using the needle cap as described in the instruction leaflet provided with the pen injection device.

The provided 510(k) Premarket Notification for the NovoFine® 32G Tip Disposable Needle does not contain detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in terms of performance metrics based on detailed statistical analysis. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding device performance results in a quantitative manner (e.g., minimum tensile strength: X, device measurement: Y).

Instead, the submission states:

• Claimed Performance: "NovoFine® 32G Tip needles meet all applicable product and quality standards for hypodermic single lumen needle products."
• Study Type: "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards."

Without the specific standards referenced and the detailed results of those tests, a precise table cannot be constructed. The "acceptance criteria" are implied to be compliance with these "existing domestic and international standards" for hypodermic needles.

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

The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it's a medical device, it's highly likely the testing was prospective, but this is not confirmed in the text.

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

This information is not applicable as the device is a sterile disposable hypodermic needle and the evaluation is based on engineering and biocompatibility standards, not on interpretations by medical experts for diagnostic accuracy. Ground truth, in this context, would be established by validated test methods and reference materials, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used for expert review in clinical studies, typically for diagnostic devices or algorithms.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI systems where human readers interpret data, and the device aims to assist or replace that interpretation. This device is a physical sterile needle.

6. If a Standalone Study Was Done

Yes, in essence. The submission indicates "Biocompatibility and performance tests have been performed." These tests would be conducted on the NovoFine® 32G Tip needles themselves, in a "standalone" fashion, to confirm they meet relevant physical, chemical, and biological safety standards specified for hypodermic needles. The performance is assessed against these established standards, which serve as the implicit acceptance criteria.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be established by:

• Validated test methods: e.g., sterility tests, needle strength tests, material composition analysis.
• Reference standards: Established specifications for materials, dimensions, and performance of hypodermic needles as outlined in "existing domestic and international standards" (e.g., ISO, ASTM standards relevant to medical devices and needles).
• Biocompatibility guidelines: Meeting established criteria for biological safety as per international standards (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI algorithm, so there is no "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated above.

Summary of what is known from the document regarding compliance:

The primary method used to demonstrate safety and effectiveness for the NovoFine® 32G Tip Disposable Needle is substantial equivalence to a previously cleared predicate device (NovoFine® 31G x 6 mm needle, K002403) and compliance with relevant non-clinical performance and biocompatibility standards. The document states: "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." This statement serves as the general proof that the device meets the implicit acceptance criteria defined by those standards. However, the specific details of these tests (e.g., sample sizes, specific criteria, detailed results) are not provided in this 510(k) summary.

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NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

The NovoFine® Autocover™ 30G x 8mm needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle cap is removed. Prepare for injection by following the procedure described in the instruction leaflet provided with the pen injection device and instructions from your health care professional. While pushing the needle into the skin, the shield and lock will be pushed into the house enabling the needle to penetrate the skin barrier and into the subcutaneous tissue.

After the injection, the needle is removed from the skin. The NovoFine® Autocover™ needle stick safety mechanism will activate automatically when the needle is withdrawn from the skin. Once NovoFine® Autocover™ is in the locked position, it can no longer be used. The needle is not exposed protecting against an unintentional needlestick. The red indicator windows tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine Autocover by using the needle cap as described in the instruction leaflet

This retrieved document is a 510(k) Premarket Notification for the NovoFine® Autocover™ 30G Disposable Safety Needle. It details the device's description, intended use, and claims substantial equivalence to predicate devices. It does not contain a quantitative study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics and statistical analyses.

Instead, the document highlights:

• Substantial Equivalence: The primary assertion is that the NovoFine® Autocover™ 30G needle is substantially equivalent to existing predicate devices (NovoFine® 31G x 6 mm needle (K002403) and BD SafetyGlide™ 25G x 16mm needle (K951254)) in terms of intended use, technology/principle of operation, materials, and performance. This is the basis for FDA clearance in this document.
• Non-Clinical Tests: States that "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." However, it does not provide the specific acceptance criteria, test methodologies, or results of these tests.
• Clinical Tests (Handling Tests): States that "Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses." Again, it does not provide specific acceptance criteria, detailed methodology, sample sizes, or quantitative results from these tests. It only concludes that "Differences between the devices tested do not raise any significant issues of safety and effectiveness."

Therefore, based solely on the provided text, I cannot complete the requested tables and information blocks with specific quantitative data on acceptance criteria and device performance from a formal study.

However, I can extract the information that is present and explain what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not specified. The document mentions "handling tests" conducted by "diabetes nurse educators, diabetes patients and staff nurses" but does not quantify the number of participants or the number of tests performed.
• Data Provenance: Not explicitly stated, but the submission is from Novo Nordisk Inc. in Princeton, New Jersey, USA. The "handling tests" imply a prospective clinical use environment, likely within the US given the submission context.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The "handling tests" involved "diabetes nurse educators, diabetes patients and staff nurses." Their specific qualifications (e.g., years of experience) are not provided.
• Qualifications of Experts: "Diabetes nurse educators, diabetes patients and staff nurses."

4. Adjudication Method

• Adjudication Method: Not mentioned. The handling tests appear to be a qualitative assessment of ease of use and safety, not a formal adjudication process for establishing a "ground truth" in the typical sense of measuring diagnostic accuracy.

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

• MRMC Study: No, this document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a safety needle, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, this document does not describe a standalone algorithm performance study. The device is a physical medical device (safety needle).

7. Type of Ground Truth Used

• Type of Ground Truth: The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology, outcomes data) is not applicable here. The "handling tests" evaluated user experience, efficacy of the safety mechanism, and overall safety. The "ground truth" for compliance with standards would be established by the results of those standard tests (e.g., tensile strength, biological reactivity), which are stated as being in compliance but not detailed.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of what the document implies about meeting acceptance criteria:

The document asserts that the device meets acceptance criteria primarily through:

1. Substantial Equivalence: By demonstrating that the device is fundamentally similar in design, materials, and intended use to previously cleared predicate devices.
2. Compliance with Standards: By stating that non-clinical performance and biocompatibility tests were conducted and found to be in compliance with existing domestic and international standards.
3. Positive User Feedback/Handling Test Results: Indicating that handling tests by target users (nurse educators, patients, staff nurses) showed no significant issues regarding efficacy and safety.

Crucially, the document is a summary and does not include the detailed reports of these tests, which would contain the specific acceptance criteria and the raw or summarized performance data against those criteria. Its purpose is to demonstrate substantial equivalence for regulatory clearance, not to publish a detailed scientific study.

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