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The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube. The insulin pen needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.

The provided document is a 510(k) summary for an Insulin Pen Needle. It details the device, its intended use, comparison with a predicate device, and performance data from non-clinical tests.

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

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

The document lists standards that the device conforms to, and states that testing results were in conformance or met acceptance criteria. Specific quantitative acceptance criteria or reported performance values are generally not provided in this 510(k) summary format, which often focuses on demonstrating compliance with recognized standards rather than presenting raw data or detailed performance metrics.

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 sample sizes for any of the tests conducted. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. It only mentions that the manufacturer is in Anhui, China, and the correspondent is in Shanghai, China, implying the tests were likely performed or managed from China.

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 and not provided in the document. The device is an Insulin Pen Needle, which is a physical medical device. Its performance is evaluated through bench testing against recognized standards (e.g., ISO, ASTM, USP) and biocompatibility testing, not through expert-reviewed diagnostic outputs that require a "ground truth" derived from human experts.

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

This information is not applicable and not provided. As explained above, the device's performance is determined by objective physical and chemical tests, not by human interpretation or clinical 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 and not provided. MRMC studies are relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like an Insulin Pen Needle. The document explicitly states "Clinical testing: Not Applicable."

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

This information is not applicable and not provided. This question pertains to AI/algorithm performance. The device is a physical medical device, not an algorithm.

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

This information is not applicable for this device. Ground truth is generally used in diagnostic studies or AI performance evaluations against a known correct answer. For an Insulin Pen Needle, performance is assessed against established engineering and biological standards.

8. The sample size for the training set

This information is not applicable and not provided. A training set is used for machine learning algorithms. The device is a physical medical device.

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

This information is not applicable and not provided. This question pertains to machine learning.

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The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen iniector devices for the injection of insulin.

The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 5mm, 6mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.

The provided text describes the acceptance criteria and study for an Insulin Pen Needle (Ordinary Type, Safety Type), not an AI/algorithm-based device. Therefore, many of the requested points, such as MRMC studies, training set details, or expert ground truth establishment for AI, are not applicable.

However, I can extract the information relevant to the medical device's performance and testing as described in the 510(k) summary.

Here's a breakdown based on the provided document:

Device Type: Insulin Pen Needle (Ordinary Type, Safety Type) - This is a physical medical device, not a software/AI device.

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

The document refers to adherence to various ISO standards and specific test results, but does not present a single consolidated table of "acceptance criteria" vs. "reported performance" in a quantitative manner for all aspects. Instead, it states that the device "met all design specifications" and "complies with the following standards."

Here's an attempt to extract the closest information, primarily by listing the standards the device claims to conform with for performance characteristics:

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

• Simulated Clinical Use Study (Safety Type only): 600 device samples.
• Data Provenance: Not specified in terms of country of origin for testing data. The manufacturer is in Tianjin, China. The testing appears to be non-clinical, laboratory-based performance testing rather than human clinical study data. It is a non-clinical study, not a retrospective or prospective human data study.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/machine learning data is not relevant here. Performance is assessed against engineering standards (e.g., ISO, USP) and physical properties.

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

• Not Applicable. As this is not a study requiring human interpretation or labeling of data (like medical imaging), there's no adjudication method in the described testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/software device. No human-in-the-loop studies or MRMC studies were conducted.

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

• Not Applicable. This is not an AI/software device. "Standalone performance" in this context would refer to the device's adherence to its design specifications and relevant standards, which was evaluated through non-clinical testing.

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

• Not Applicable. For a physical device, "ground truth" is defined by established engineering and biological standards (e.g., ISO, USP), material specifications, and physical measurements. The "truth" is whether the device physically meets these specifications and passes the required tests.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not Applicable. There is no "training set." The performance of the device is assessed against pre-defined engineering standards and test methods.

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The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.

The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.

This document describes the Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) by Tianjin Huahong Technology Co., Ltd. being substantially equivalent to predicate devices. The information provided heavily focuses on comparisons to predicate devices and adherence to various ISO standards and FDA guidelines, rather than presenting a standalone study with acceptance criteria and device performance in a typical clinical measurement context.

Here's an attempt to extract and synthesize the requested information, acknowledging that some details, especially concerning statistical performance measures for clinical efficacy, are not explicitly provided in this type of 510(k) summary. The document emphasizes adherence to technical standards and biocompatibility, which are critical for medical devices but different from performance metrics for diagnostic or therapeutic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to international standards and predicate device characteristics. Since this is a 510(k) submission for pen needles, the "performance" is generally about meeting physical, chemical, and biological safety requirements, rather than a diagnostic accuracy or treatment effectiveness metric as might be seen for other types of devices.

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

• Simulated Clinical Use Study (for Safety Type):

  • Sample Size: 600 device samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it was a "simulated clinical use study," implying prospective testing under controlled conditions.

• Other Non-clinical Tests (e.g., physical, mechanical, biocompatibility, sterility):

  • Specific sample sizes for each test are not provided in this summary. These tests are typically conducted on representative batches of the manufactured device.
  • Data Provenance: These are laboratory-based, non-clinical tests, not involving human subjects or patient data. The manufacturer (Tianjin Huahong Technology Co., Ltd. in China) conducted or commissioned these tests.

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

This type of information (number and qualifications of experts for ground truth) is relevant for studies involving subjective assessment or interpretation (e.g., imaging devices, diagnostic algorithms). For physical medical devices like insulin pen needles, "ground truth" is typically established by objective measurements against established engineering standards and biological safety tests. Therefore, this information is not applicable and not provided in the document. The "ground truth" is the objective standard itself (e.g., SAL of 10^-6, absence of cytotoxicity).

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1 for resolving discrepancies in expert opinions) are used in studies where subjective evaluations are made. For pen needles, performance is assessed against objective, measurable criteria and standards.

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 (insulin pen needle), not an AI-powered diagnostic or assistive technology that involves "human readers" or AI assistance.

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.

7. The type of ground truth used

The "ground truth" for the performance claims of these insulin pen needles is based on:

• International Standards: Adherence to established ISO standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 23908) for physical, mechanical, and safety properties.
• Biocompatibility Standards: Adherence to ISO 10993 series for biological evaluation of medical devices.
• Pharmacopoeia Standards: Adherence to USP <788> for particulate matter and USP <85> for endotoxin limits.
• Engineering Specifications: Device specifications (e.g., material composition, dimensions, bond strength) measured against defined tolerances.
• Predicate Device Comparison: Establishing substantial equivalence by demonstrating that the proposed device performs comparably to legally marketed predicate devices regarding safety and effectiveness.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device submission, not an AI/ML device.

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

Not applicable. As explained above, this is not an AI/ML device.

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The Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

The proposed device, Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.

The Pen Needle is offered in various gauge size and length.

The proposed device is available in radiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the "Easy Drip Disposable Insulin Needle" to a predicate device.

Here's a breakdown of the requested information:

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 the exact sample sizes used for each non-clinical test. However, it indicates that "nonclinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective; these are laboratory bench tests.

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

Not applicable. These were non-clinical bench tests performed against established international standards (ISO, ASTM, USP). Expert consensus is not typically used to establish ground truth for these types of tests; rather, the ground truth is defined by the objective pass/fail criteria of the specified standards.

4. Adjudication method for the test set

Not applicable. As noted above, these were objective non-clinical bench tests against standardized criteria.

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 document pertains to a medical device (insulin needle) and its non-clinical performance and biocompatibility, not an AI-assisted diagnostic tool.

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.

7. The type of ground truth used

The ground truth for the non-clinical tests was established by adherence to and compliance with relevant international and national standards, including:

• ISO 7864 (Sterile hypodermic needles for single use)
• ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)
• ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
• ISO 10993 series (Biological evaluation of medical devices, including parts 4, 5, 10, 11)
• ASTM F765 (Standard Practice for Assessment of Hemolytic Properties of Materials)
• USP <151> Pyrogen Test
• USP <85> Bacterial Endotoxins Test

8. The sample size for the training set

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

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

Not applicable, for the same reason as above.

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The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.

The provided text describes a 510(k) summary for an Insulin Pen Needle, focusing on its substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, primarily through non-clinical testing and comparison to existing standards.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable or detailed in this document.

Here's an breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the typical sense of a clinical or performance study. Instead, it states that the device 'complies with' various ISO and ASTM standards, which inherently define performance requirements. The performance specification for the proposed device is listed as "Comply with ISO 7864, ISO 9626, and ISO 11608-2."

Implicit Acceptance Criteria and Reported Performance (derived from compliance with standards and comparison table):

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

The document indicates "Non clinical tests were conducted to verify that the proposed device met all design specifications," but it does not specify the sample sizes used for these tests. The data provenance is not explicitly stated in terms of country of origin for specific test results, but the sponsor is located in China. The tests are non-clinical (laboratory-based) rather than retrospective or prospective human clinical data.

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

Not applicable. This document describes non-clinical performance testing against established engineering standards (ISO, ASTM, USP). There is no "ground truth" in the clinical sense established by human experts for a test set. The standards themselves define the "ground truth" for performance.

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

Not applicable. As the tests are non-clinical, there is no need for expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (Insulin Pen Needle), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance is 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. There is no "algorithm only" performance to evaluate.

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

For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements set forth in the referenced international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-7, ASTM F88/F88M-09, ISO 11737-2, USP 35-NF30:2012). The device's performance is compared against these engineering and manufacturing benchmarks.

8. The sample size for the training set

Not applicable. This pertains to non-clinical device testing and manufacturing compliance, not a machine learning model that requires a training set.

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

Not applicable. There is no training set mentioned in the context of this device submission.

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The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

The provided text describes the submission for an Insulin Pen Needle for 510(k) clearance, intending to prove substantial equivalence to a predicate device, not an AI/ML-based medical device. Therefore, many of the requested criteria related to AI/ML model evaluation (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this submission.

However, I can extract information regarding the device's performance criteria and how its compliance was demonstrated through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, focusing on the relevant sections for a non-AI/ML device:

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

The acceptance criteria for the Insulin Pen Needle are primarily based on compliance with established international standards for medical devices, specifically needles and injection systems. The reported device performance is that it complies with these standards.

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

The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." However, it does not specify the sample sizes used for these non-clinical tests. The tests were performed to demonstrate compliance with international standards, which typically involve specific sample size requirements as part of the test methodology outlined in those standards. The data provenance is internal testing performed by the manufacturer (Wenzhou Beipu Science & Technology Co., Ltd) implicitly in China, as that is their location. These would be prospective tests performed specifically for this submission.

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 as this is a physical medical device, not an AI/ML model requiring expert annotation for ground truth. Compliance with performance standards is typically measured by laboratory testing according to defined protocols, not expert consensus on images or data.

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

Not applicable for a physical device's performance testing. Test results are typically objective measurements against a defined 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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's inherent performance as measured by physical and biological tests against established standards.

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

The "ground truth" for this device's performance is compliance with established, objective, and predefined engineering, materials, and biological standards (e.g., ISO, ASTM, USP). This is demonstrated through laboratory testing, not human expert interpretations or clinical outcomes data in the way an AI model would be validated.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.

Insulin pen needle is a single-use device, which consists of needle tube, needle shield, needle seat, needle seat protection cover, and seat seal paper. Needle gauge includes 29G, 30G, 31G, and 32G. Needle length can be produced to various sizes. After sterilization by EO, it's sterile, pyrogen free, and non-toxic. Its shelf life is 5-year.

The provided text describes a 510(k) submission for an insulin pen needle. This type of medical device is generally evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than through complex clinical studies with human participants, AI algorithms, or extensive ground truth establishment. Therefore, many of the requested categories are not applicable in this context.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

• Sample Size for Test Set: Not explicitly mentioned for specific test types, but implied to be sufficient for ISO compliance and biocompatibility testing. This typically involves a statistically relevant number of samples per test as outlined by the standards.
• Data Provenance: The device manufacturer is Tiger Medical Products Ltd. in Shanghai, China. The testing was conducted by or on behalf of the manufacturer, likely in China or by certified labs. The tests are non-clinical (bench and biocompatibility).

2. 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 is a non-clinical device that relies on standardized performance and biocompatibility testing, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is established by the specifications of the ISO standards and the verifiable results of the tests.

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

• None. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human interpretation is involved. For this device, performance is measured against established engineering and biological standards.

4. 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 single-use insulin pen needle, not a diagnostic or AI-powered device involving human readers.

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

• Not Applicable. This device does not incorporate any algorithms or AI component.

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

• Standardized Test Results/Compliance with ISO Standards and Biocompatibility Protocols. The "ground truth" for this device lies in its ability to meet the defined technical specifications of ISO 11608-2, ISO 9626, ISO 7864, and the biological safety requirements of ISO 10993. This is verified through laboratory testing (e.g., force measurements, flow rates, sterility tests, cytotoxicity assays).

7. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or corresponding ground truth to establish.

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