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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample.

The intended users include Healthcare personnel, patients and lay persons.

Model XXXVI, the safety lancets consist of needle core, button, housing, protective cap and spring.

The sterile part of the safety lancet is the needle tip.

The sterile barrier is the needle sleeve and sterilized to a SAL of 10⁻⁶ by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

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Lancet: The lancet is intended for capillary blood sampling.
Lancing device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)

Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device: Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel. The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first. For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first. The Lancing Device is provided non-sterile.

The provided text is a 510(k) summary for a medical device (Lancet and Lancing Device). This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical studies or AI/software performance evaluations. Therefore, many of the requested details related to "AI performance," "expert ground truth," "MRMC studies," and "training sets" are not applicable to this document.

However, I can extract the relevant acceptance criteria and study information provided for this medical device based on the document's content.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of quantitative acceptance criteria and corresponding performance metrics for the device in the format common for AI/software devices. Instead, it generally states that the device "met the performance criteria outlined" and that "all verification and validation tests passed without deviations." The performance evaluation for this device category (lancets and lancing devices) would typically involve mechanical, sterilization, biocompatibility, and functional tests.

Here's an interpretation of the implied acceptance criteria and reported performance based on the "Non-Clinical Testing" section:

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

• Test Set Sample Size: For the Simulated Clinical Use study, 640 device samples were used for both the Lancet and the Lancing Device. Other performance and biocompatibility tests would have their own sample sizes, but these are not explicitly stated in this summary for each specific test (e.g., mechanical tests, needle integrity, etc.).
• Data Provenance: The studies were conducted by Tianjin Huahong Technology Co., Ltd. (China). The data origin is thus China. The studies described are prospective tests performed on the new device, not retrospective data analysis.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This device is a mechanical medical device, not an AI/software device that requires expert radiological or clinical interpretation to establish ground truth for performance evaluation in the way AI algorithms do. The "ground truth" for this device's acceptance is based on engineering specifications, physical measurements, biological safety tests (biocompatibility), and functional performance tests against established standards.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software performance study relying on human interpretation, there is no "adjudication" in the sense of reconciling expert opinions. Performance is assessed against quantitative engineering specifications and standard test methods.

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 is for a mechanical medical device (lancet and lancing device), not an Artificial Intelligence (AI) or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

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

Not applicable. This is not an algorithmic device. Performance is evaluated through physical and functional testing of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for showing the device meets acceptance criteria is based on:

• Engineering Specifications/Standards: Performance criteria outlined in internal specifications and relevant international standards (e.g., ISO 23908 for sharps injury prevention, ISO 10993-1 for biocompatibility).
• Physical Measurements: E.g., needle length range, gauge range.
• Functional Testing: Demonstrating the device performs its intended action (capillary blood sampling, proper retraction).
• Biocompatibility Testing: Laboratory results confirming non-toxicity and safety of materials.
• Safety Mechanism Testing: Verification that sharps injury prevention features work as intended.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth establishment for a training set.

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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample. Model XXXV, the safety lancets consist of needle core, button, housing and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Safety Lancet (Model XXXV).

The document is a 510(k) summary for a medical device called "Safety Lancet (Model XXXV)" submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a predicate device already legally marketed in the US. This type of submission generally relies on non-clinical testing rather than extensive clinical trials for devices like lancets.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Bench Testing: The document does not specify a separate "test set" sample size for the core performance criteria (launch, puncture force, lubricant, disposable, safety feature) beyond indicating that these tests were performed and met requirements.
   • Biocompatibility Testing: Not specified for individual tests.
   • Simulated Clinical Use Study: 300 device samples were used.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from a Chinese manufacturer (Tianjin Huahong Technology Co., Ltd.) to the US FDA, the testing was likely conducted in accordance with international standards to satisfy US regulatory requirements.

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

   • This information is not provided. For device performance testing of this nature (bench tests for physical characteristics and biocompatibility), "experts" in the sense of clinical decision-makers establishing ground truth for disease states are typically not involved. The "ground truth" is established by predefined engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and objective measurements.

3. Adjudication Method for the Test Set:

   • Not applicable as the testing involves objective measurements against pre-defined engineering and regulatory standards rather than subjective human interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-assisted diagnostic devices where human readers provide interpretations. This device is a simple mechanical blood sampling device.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is a mechanical medical device, not an algorithm or AI product.

6. Type of Ground Truth Used:

   • Bench Testing: Engineering specifications, objective measurements, and compliance with general safety and performance requirements (e.g., smooth operation, proper safety mechanism function).
   • Biocompatibility Testing: Results of standardized in-vitro and in-vivo tests according to ISO 10993 series standards, demonstrating absence of cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity.
   • Simulated Clinical Use: Pre-established criteria defined by FDA Guidance and ISO 23908 for evaluating the safety mechanism of sharps injury prevention features.

7. Sample Size for the Training Set:

   • Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above.

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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
According to surface difference or structure, the Safety lancets have 7 models: XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.
XXIX, XXX model have sub model according to surface difference.
For Model XXVIII and XXX, the safety lancets consist of needle core, button, housing and spring. For Model XXIX, the safety lancets consist of needle core, button, housing, spring, and Depth adjuster ring. For Model XXXI, the safety lancets consist of needle core, top cover, bottom and spring. For Model XXXII, the safety lancets consist of needle core, top cover, bottom, small lid and spring. For Model XXXIII, the safety lancets consist of needle core, button, housing, inner sleeve and spring. And for Model XXXIV, the safety lancets consist of needle core, button, housing, bottom, Protective cap and spring.
The sterile part of the safety lancet is the needle tip.The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

This document is a 510(k) summary for a medical device called "Safety Lancet," and it does not contain information about an AI/ML powered device. The information provided is for a physical medical device (safety lancets) used for capillary blood sampling. Therefore, many of the requested fields related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this physical device.

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

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

• Simulated Clinical Use Study: 300 device samples each for the Safety Lancet (various models).
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). This was a bench test and simulated use study, not a human data study.

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. The "ground truth" for this physical device was based on objective physical measurements and established biological safety standards from ISO 10993 and FDA guidance, not expert interpretation of data.

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

Not applicable. This was a non-clinical bench and simulated use study, not a study requiring adjudication of expert opinions.

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/ML powered device.

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

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

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

For bench testing: Objective physical measurements and adherence to functional specifications.
For biocompatibility testing: Laboratory results following ISO 10993 standards.
For simulated clinical use: Evaluation of the safety mechanism against pre-established criteria defined by FDA Guidance (Medical Device with Sharps Injury Prevention Feature) and ISO 23908.

8. The sample size for the training set

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

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

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

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Lancet: Lancet is intended for capillary blood sampling.
Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.

Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle (made of stainless steel and silicone oil), main body and protective cap (both made of PE, EVA and calcium powder). Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device: Along with a lancet, the lancing device is used to collect a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM and PC Resin. And the spring is made of carbon steel. The service life of lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) is no more than 3000 times or 3 years. The service life of lancing device (HH-XVII-T) is no more than 5000 times or 5 years. The Lancing Device is provided non-sterile.

The provided text describes the non-clinical testing performed to demonstrate that the proposed Lancet and Lancing devices meet acceptance criteria.

Here's the breakdown of the information requested:

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

Biocompatibility Testing:

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

For the simulated clinical use study, 500 device samples each for the Lancet and Lancing Device were used. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but it is a "simulated clinical use study," implying it was conducted as part of the device's development/testing process. The manufacturer is Tianjin Huahong Technology Co., Ltd. in Tianjin, 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 provided in the document. The studies described are non-clinical bench testing and simulated clinical use for safety mechanisms, which typically do not involve expert-established ground truth in the same way imaging or diagnostic algorithms would.

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

This information is not applicable/not provided for the types of non-clinical bench tests and simulated clinical use study described. Adjudication methods are more pertinent to studies involving human interpretation or subjective assessments.

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

No MRMC comparative effectiveness study was done. The submission explicitely states: "No clinical study is included in this submission." The device being described is a physical medical device (lancet and lancing device), not an AI-powered diagnostic or interpretive system that would typically undergo an MRMC study.

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

Not applicable. This device is a physical medical device (lancet and lancing device), not an algorithm or AI system.

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

For the non-clinical tests (appearance, dimension, needle diameter, cleanness, firmness, corrosion resistance, acidity/alkalinity, extractable metals, puncture force, lubricant, matching) and biocompatibility tests, the "ground truth" is defined by the pre-established physical, chemical, and biological requirements and standards (e.g., drawings, ISO standards, specific chemical limits). For the simulated clinical use, the ground truth is whether the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA guidance and ISO 23908.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI or algorithm that requires a training set.

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

Not applicable. No training set was used as this is not an AI/algorithm device.

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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 safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample. The intended users include Healthcare personnel, patients and lay persons. According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference. For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

The provided text describes the 510(k) summary for a Safety Lancet device, specifically K220370. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and simulated clinical use. It is a regulatory submission for a medical device rather than a report detailing a clinical trial or an AI/software as a medical device (SaMD) study. Therefore, many of the requested details, such as the use of AI, human reader studies, and sophisticated ground truth establishment, are not applicable to this type of device submission.

However, I can extract the relevant information from the provided text regarding acceptance criteria and the studies performed for this specific medical device.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

Here's a table summarizing the acceptance criteria and reported device performance based on the "Non-Clinical Testing" section:

Summary of Device Performance Study Information:

The provided document describes physical and biological tests for a medical device (Safety Lancet), not an AI/Software as a Medical Device (SaMD). Therefore, many of the questions related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI models are not applicable.

Here's the information that is extractable from the provided text:

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

   • Simulated Clinical Use: 500 device samples were used for the simulated clinical use study.
   • Non-Clinical Testing: The sample sizes for the individual bench tests (e.g., appearance, dimension, firmness) are not explicitly stated, but it's implied that sufficient samples were tested to "Meet the requirement."
   • Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" and "simulated clinical use," implying lab-based testing rather than clinical patient data. The document is a 510(k) submission to the FDA, from a company in Tianjin, China.

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

   • Not applicable in the context of this device's testing. Ground truth for physical characteristics (e.g., dimensions, corrosion) is established by measurement against predefined specifications, not by expert consensus in this specific case.
   • For biocompatibility testing, compliance with ISO 10993 series standards is the "ground truth," evaluated by laboratory tests performed by qualified personnel, but not "experts" in the sense of radiologists.

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

   • Not applicable as this is not a study requiring adjudication of interpretations (e.g., imaging reads). The tests are objective measurements or categorical observations (e.g., "no burr," "no corrosion").

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:

   • No. This is a physical medical device (Safety Lancet), not an AI/software. Therefore, no MRMC study with human readers was conducted or is applicable.

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

   • Not applicable. This is not an algorithm or AI device. The testing described is for the physical performance and safety features of the lancet itself.

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

   • For Non-Clinical Testing (bench tests): The ground truth is based on engineering specifications, industry standards (e.g., ISO 9626 Annex A for pH, specific limits for extractable metals), and established physical or visual inspection criteria (e.g., "free of burr," "no dust," "no evidence of corrosion").
   • For Biocompatibility Testing: Ground truth is established by adherence to and passing results from tests specified in ISO 10993 series standards (e.g., "No Cytotoxicity," "No Skin Sensitization").
   • For Simulated Clinical Use: The ground truth is whether the device "met the pre-established criteria" for its safety mechanism, evaluated according to FDA Guidance and ISO 23908.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model that requires a training set.

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

   • Not applicable. As noted above, there is no AI training set for this device.

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Heel Stick Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm). It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. Heel stick safety lancet is intended to be used by professionals. The product is intended for prescription (Rx) only.

This document describes the premarket notification (510(k)) for the "Heel Stick Safety Lancet (HHZ-II, HHZ-III)" and does not involve an AI or Machine Learning (ML) enabled device. Therefore, many of the typical acceptance criteria and study components requested in the prompt, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable.

The acceptance criteria provided for this device concern its physical and performance characteristics as a manual surgical instrument, not an AI model.

Here's an attempt to answer the prompt based on the provided document, highlighting where the requested information is not relevant due to the nature of the device:

Device: Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Device Type: Manual Surgical Instrument For General Use (Lancet)

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing Acceptance and Results:

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

For the Simulated Clinical Use study to evaluate the safety mechanism:

• Sample Size: 600 device samples each for the HHZ-II and HHZ-III models (implicitly, 1200 samples total, though not explicitly stated as combined).
• Data Provenance: Not specified, but generally, bench testing and simulated clinical use for a medical device cleared via 510(k) are conducted by the manufacturer or their contracted laboratories to demonstrate compliance with standards. It's a prospective test of the device. Country of origin not specified for the test data, but the manufacturer is in China.

For the Non-Clinical (Bench) Testing (Appearance, Cleanness, Dimension, etc.):

• Sample Size: Not explicitly stated for each test, but standard quality control and performance testing typically involve a defined sample size from production batches.
• Data Provenance: Not specified, likely internal testing by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable as the device is a manual lancet and the studies are performance/bench/biocompatibility tests, not studies involving expert adjudication of AI outputs or clinical interpretations. The "ground truth" for these tests is based on measurable physical properties and specified standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing performed. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human interpretation (e.g., for image reading in AI studies), not for mechanical device performance or biocompatibility testing. The "ground truth" (acceptance criteria) for the bench tests are against physical measurements and functional performance as per engineering specifications and relevant ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools to assess the impact of AI on human reader performance. The Heel Stick Safety Lancet is a manual instrument.

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

No, a standalone algorithm performance study was not done. This is not an AI/algorithm-based device. The "simulated clinical use" mentioned is a physical test of the device's safety mechanism, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the Heel Stick Safety Lancet consisted of:

• Pre-defined engineering specifications and measurable physical properties: For criteria like appearance, cleanness, dimensions, firmness, launch performance, launch depth/width, activating force, and sharp access in safe mode.
• Compliance with international standards: Specifically, ISO 23908 for evaluating the safety mechanism and ISO 10993 series for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical, manual medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as there is no AI/ML training set for this device.

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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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