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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet could be divided into Model XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.

Model XA Pro is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted automatically back into the housing after the puncture due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.

Model ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.

The provided document is a 510(k) summary for a "Safety Lancet" (K242627). It details the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device (K222090).

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 individual test within the "Performance Test" section. It broadly states that "All non-clinical bench testing performed on the subject device is to demonstrate the substantial equivalence to the predicate devices."

For the "Performance of Clinical Simulated Use Testing for Sharps Injury Protection," it states: "Select the most widely sold in the market of each model as typical product for study." This suggests a limited sample size focused on representative models, but the exact number isn't provided.

The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. Given the manufacturer is Ningbo Medsun Medical Co., Ltd. in China, it's highly likely the testing was conducted in China. The "non-clinical bench testing" and "clinical simulated use testing" imply a prospective testing approach dedicated to this submission.

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

The document does not involve expert-established ground truth in the traditional sense for diagnostic AI/software. The testing described is for a physical medical device (safety lancet) and focuses on engineering and performance criteria. The "ground truth" for the performance tests would be objective measurements and observations against pre-defined engineering and safety standards. No human expert consensus for a diagnostic outcome is relevant here.

4. Adjudication method for the test set

Not applicable. This is not a diagnostic study requiring human adjudication for interpretation. The performance tests involve objective physical and chemical measurements.

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 submission for a physical medical device (safety lancet), not an AI-powered diagnostic tool, and therefore an MRMC study 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.

7. The type of ground truth used

The ground truth used for these tests are the pre-defined technical specifications, engineering requirements, and safety standards (e.g., ISO 23908:2011, ISO 10993 series, and 21 CFR 801). The "Passed" results indicate that the device met these objective criteria.

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."

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

Not applicable. There is no training set for a physical safety lancet.

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years. Product Structure of the Safety Lancet are summarized in the table below: Model XY is composed of a protective cap, slider, front spring, housing, needle body with a tri-bevel edge needle or blade, a rear spring, and a back cover. The needle body is hidden inside the housing/slider, and the housing is color-coded for different versions. Model XH is composed of a protective cap, front spring, housing, needle body, rear spring, and back cover. Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions. There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.

The provided text describes a 510(k) submission for a Safety Lancet, demonstrating its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, detailed study results, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, or MRMC study information that you requested.

The document states that the device meets certain performance criteria through "non-clinical bench testing" and adherence to ISO standards, but it only lists the types of tests performed, not the quantitative acceptance criteria or the specific results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Details: The document only states that these tests were "verified" or "meet requirements." It does not provide specific quantitative acceptance criteria for each test (e.g., what is the acceptable range for penetrating force, or the specific dimensions) nor does it provide the numerical results for the device's performance against these criteria. It simply generally affirms that the design was "verified."

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

• Sample Size for Test Set: Not specified. The document only mentions "non-clinical bench testing."
• Data Provenance: Not specified. It's implied this testing was conducted by the manufacturer, Ningbo Medsun Medical Co., Ltd., in China, as part of their design control process. The data is likely retrospective in the sense that it was collected during product development/verification prior to this submission.

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

• Number of Experts: Not applicable. This is a non-clinical device (Safety Lancet), not an AI/software device that typically requires expert-established ground truth for performance evaluation in a clinical context. The "ground truth" here is adherence to engineering specifications and international standards.
• Qualifications of Experts: N/A for the reasons above.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This is a non-clinical device. The verification is based on objective measurements against defined specifications and standards, not subjective expert judgment.

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

• MRMC Study: No. This is a physical medical device (Safety Lancet), not an AI-powered diagnostic or assistive tool.

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

• Standalone Performance: Not applicable. This device does not involve an algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance primarily relies on engineering specifications, direct physical measurements, and adherence to established international standards (e.g., ISO 9626, ISO 7864, ISO 10993 series).

8. The sample size for the training set

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

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

• Ground Truth for Training Set Establishment: Not applicable. No training set is used.

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Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose.

Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.

Lance Device have two parts, lancet and lancing device. Lancet is composed of a lancet body, a needle and a protective cap. Lancing device is mainly composed of depth adjustment tip, cap, release button, shield, rear sliding barrel and an ejector. The cover consists of inner cover, cap inner core, rear sliding barrel, inner core, buckle ring and two springs, with 12 depth adjustment gears.

The lancet is provided as sterile state and have four model: Model BYY3, Model BYY4, Model BYB and Model BYC. The lancet body of Model BYY3 and Model BYY4 is circular, and the lancet body of Model BYB and Model BYC is flat. The lancing device is provided as non-sterile state and a reusable medical device for use only on a single patient and have four model: Model CX11B1, Model CX11B2, Model CX11C1 and Model CX11C2. Model CX11 Lancing device is divided into CX11B (threaded connection) and CX11C (buckle connection) according to the different connection structures of the cap and body of the lancing device. Model CX11B is divided into CX11B1 (suitable for round lancet) and CX11B2 (suitable for flat lancet) according to the different structure of the lancet. Model CX11C is divided into CX11C1(suitable for round lancet) and CX11C2(suitable for flat lancet) according to the different structures of the lancet.

The lancet is sterilized by Gamma ray and for single use,the shelf life is 5 years. The lancing device is provided as non-sterile state,for use only on a single patient. The useful life is 5 years or 6000 times.

This document primarily outlines the premarket notification (510(k)) for a Lancing System, focusing on demonstrating its substantial equivalence to a predicate device based on bench testing and biocompatibility assessments. It does not present a study with specific acceptance criteria and reported performance data for a standalone or human-in-the-loop AI/ML device.

The document describes a medical device (Lancing System) used for obtaining capillary blood samples, not an AI/ML-driven diagnostic or assistive system. Therefore, the questions related to AI/ML specific performance, such as MRMC studies, standalone algorithm performance, expert ground truth establishment for test sets, and training set details, are not applicable to the information provided in this 510(k) summary.

The "Performance testing summary" section (8.0 onwards) details bench testing and biocompatibility testing conducted to demonstrate the safety and effectiveness of the physical Lancing System, but these are not related to AI/ML performance.

To address the prompt as much as possible given the provided text, I will describe the performance testing as presented for this physical medical device, acknowledging that it does not fit the AI/ML framework implied by many of the prompt's questions.

Acceptance Criteria and Study for the Lancing System (Physical Device)

This 510(k) submission for the Lancing System primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments, rather than evaluating an AI/ML-driven system. Therefore, the concepts of "acceptance criteria" and "reported device performance" are discussed in the context of the physical device's mechanical and biological properties, not AI/ML precision, recall, or reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical medical device, specific numerical acceptance criteria and precise reported performance values are typically detailed in the full test reports, which are summarized here. The summary provides a list of tests conducted and a general statement that the device meets requirements or the tests show "well" performance.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant ISO standards (e.g., for sterility, dimensions, mechanical function) and internal quality control procedures.
• Data Provenance: The document does not explicitly state the country of origin for the data collection, but the manufacturing company is "Ningbo Medsun Medical Co., Ltd." in "Ningbo, P.R.China," implying that the testing was likely conducted in China or by labs contracted within the region. The tests are presented as being conducted in support of the 510(k) submission, implying a prospective testing approach designed for regulatory clearance.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This pertains to AI/ML ground truth establishment. For a physical medical device, "ground truth" refers to the objective measurement against established standards (e.g., dimension measurements, force measurements, sterility cultures) rather than subjective expert consensus on image interpretation. Expert involvement would be in defining the standards, designing the tests, and interpreting the raw data, but not in establishing a "ground truth" derived from human interpretation.

4. Adjudication Method for the Test Set

• Not Applicable: This pertains to AI/ML test set ground truth. For physical device performance, adjudication is typically through statistical analysis of quantitative measurements against pre-defined acceptance limits, or pass/fail criteria for qualitative tests, not through expert consensus adjudication.

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

• Not Applicable: This concept is relevant for AI/ML systems that directly assist human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (lancing system) and does not involve AI assistance for human tasks that would necessitate an MRMC study.

6. Standalone (Algorithm Only) Performance

• Not Applicable: This applies to AI/ML algorithms. The Lancing System is a physical device, and there is no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

• Objective Measurements/Standards: For this physical device, the "ground truth" is established by:
  • Referenced ISO Standards: The document repeatedly mentions adherence to ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 23908:2011 for sharps injury protection, ISO 9626:2016 for needle gauges). These standards define the acceptable performance characteristics and test methods.
  • Engineering Specifications: Device dimensions, puncture force, and mechanical functions are measured against design specifications.
  • Laboratory Assay Results: Biocompatibility tests yield objective results (e.g., cell viability, presence of pyrogens) against established acceptable ranges.
  • Qualitative Assessments: Appearance and functional tests are performed against defined visual and operational criteria.

8. Sample Size for the Training Set

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

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

• Not Applicable: As there is no AI/ML training set, this question is not relevant.

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Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider, protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.

Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

The provided text is a 510(k) Premarket Notification for a Disposable Insulin Pen Needle. It focuses on demonstrating substantial equivalence to predicate devices through design comparisons and a summary of performance testing. The document does not describe a study that involves acceptance criteria for device performance based on AI or diagnostic accuracy. Instead, it details the physical and functional performance of the device based on established medical device standards.

Therefore, I cannot provide information about:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
• Sample size used for the test set and data provenance for an AI model.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the device's general performance testing and criteria based on the provided document:

The device's performance is evaluated against recognized international standards for medical devices and sterility.

Here's a summary of the performance testing and criteria mentioned, which serves as the "acceptance criteria" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

• Maximum EO residual . | - Meets requirements of ISO 10993 series standards.
• All listed specific tests performed.
• Particulate matter for injections performed per USP . |
  | Sharps Protection Features | - For Model ST: Meet requirements of safe-lock guard activation and safety overriding/unlocking force after activation (triggering performance) as per ISO 23908:2011 (Sharps injury protection). | - Model ST meets the requirements of safe-lock guard activation and safety overriding/unlocking force after activation per ISO 23908:2011. |
  | Clinical Simulated Use | - For Model ST: Demonstrate sharps injury prevention feature through clinical simulated use testing, according to ISO 23908:2011 and FDA Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features. | - Clinical simulated use testing completed for Model ST. Test results show good sharps injury prevention feature. |
  | Hub/Needle Bond Strength | - Conform with ISO 11608-2. | - Conform with ISO 11608-2. |
  | Method of Attachment | - Screw structure, conform with ISO 11608-2. | - Screw structure, conform with ISO 11608-2. |
  | Needle Tip Configuration | - Tri-bevel edge needle. | - Tri-bevel edge needle. |
  | Endotoxin Limit | - 20 EU per device. | - 20 EU per device. |

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

The document does not specify a distinct "test set" in the context of diagnostic performance or AI. Instead, it refers to samples of the device being manufactured and subjected to various physical, chemical, and biological tests according to the standards listed above. The provenance of these test samples would be the manufacturer's production line (Ningbo Medsun Medical Co., Ltd., China). The tests are prospective in the sense that they are performed on the manufactured device models to demonstrate compliance.

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

Not applicable, as this is not a diagnostic device involving expert interpretation or AI. The "ground truth" here is compliance with established international and national medical device standards, which are defined by committees of experts in the field.

4. Adjudication Method for the Test Set

Not applicable. The criteria are objective measurements and validations against 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, as this is not a diagnostic device or AI-driven system.

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

Not applicable, as this is a physical medical device.

7. The type of ground truth used

The "ground truth" is defined by the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 11135, ISO 11608-2, ISO 9626, ISO 7864, ISO 10993 series, ASTM D4169-16, ASTM F1929-2015, USP , ISO 23908:2011). These standards represent established scientific and engineering principles for medical device safety and efficacy.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.

The provided document is a 510(k) summary for the "Safety Lancet" device, which makes an equivalence claim to previously cleared predicate devices. Since this is an equivalence claim, the studies described are primarily non-clinical bench testing to demonstrate that the subject device performs as safely and effectively as the predicate devices. It does not contain information about clinical studies with human participants.

Therefore, many of the requested fields related to clinical efficacy studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this 510(k) summary. These types of studies are typically conducted for new technologies or to demonstrate clinical efficacy, which is not the primary purpose of a 510(k) submission based on substantial equivalence.

Here's the information extracted from the document based on the request:

1. Table of acceptance criteria and the reported device performance:

The document lists performance tests conducted but does not explicitly state "acceptance criteria" and "reported device performance" in a direct side-by-side format with quantitative measures for each criterion. Instead, it states that the performance data were "provided in support of the substantial equivalence determination" and that "The test results show that the product had well sharps injury prevention feature." This implies that the device met the internal (or external standard-based) acceptance criteria for each test.

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

This information is typically provided in detailed test reports, not in a 510(k) summary. The document does not specify exact sample sizes for each bench test. The studies were non-clinical bench tests. The country of origin for the studies is not explicitly stated, but the manufacturer is Ningbo Medsun Medical Co., Ltd. in 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)

Not applicable, as this was a non-clinical bench study for a physical medical device (safety lancet), not an AI/software device requiring expert interpretation for ground truth.

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

Not applicable, as this was a non-clinical bench study.

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, as this was a non-clinical bench study for a physical medical device.

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

Not applicable, as this was a non-clinical bench study for a physical medical device.

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

The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO, internal specifications) for mechanical function, material properties, sterility, and biocompatibility. For example, ISO 9626:2016 for needle dimensions or ISO 10993 series for biocompatibility.

8. The sample size for the training set

Not applicable, as this was a non-clinical bench study for a physical medical device, not an AI/software device that requires a training set.

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

Not applicable, as this was a non-clinical bench study for a physical medical device.

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