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The MICROLET®NEXT 2 Lancing Device is used with the disposable MICROLET®NEXT Lancet to obtain capillary blood samples.

The proposed MICROLET®NEXT 2 Lancing Device falls under multiple Use Blood Lancet for Single Patient Use Only category. The proposed MICROLET®NEXT 2 Lancing Device is a pen-like instruments to be used with the compatible MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing.

The provided FDA 510(k) clearance letter and summary for the MICROLET®NEXT 2 Lancing Device (K250813) addresses the device's technical characteristics, regulatory classification, and substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or detailed study results (like numerical performance metrics) typically found in a clinical study report for AI/ML-based medical devices or diagnostics.

The document describes a usability study rather than a performance study focused on specific numerical criteria for the lancing device's function (e.g., depth of penetration accuracy, blood sample volume consistency). The "acceptance criteria" in this context appear to be related to the usability and safety of the device by lay users.

Based on the provided text, here's a breakdown of the requested information, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance for MICROLET®NEXT 2 Lancing Device (K250813)

Note: The provided document describes a lancing device and its clearance based on substantial equivalence, primarily focusing on usability and safety. It does not contain quantitative performance metrics or specific "acceptance criteria" (e.g., sensitivity, specificity, accuracy percentages) typically seen for diagnostic devices or AI algorithms. The "performance" here refers to the device's ability to be used effectively and safely by lay persons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • Enrolled: 131 lay persons with diabetes.
  • Completed Study: 120 lay persons with diabetes.
• Data Provenance:
  • Country of Origin: Not explicitly stated but implied to be within the US given the FDA submission and contact information.
  • Retrospective or Prospective: Prospective ("enrolled into the study at a single clinical site").

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This was a usability study with lay users, not an expert-driven validation of a diagnostic ground truth. The "ground truth" was the ability of the lay person to successfully use the device to obtain a blood sample.

4. Adjudication Method for the Test Set

• Not Applicable. No expert adjudication of results was mentioned as the study was about user proficiency and device function in obtaining a sample, rather than interpretation of diagnostic results.

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

• No. This type of study is typically performed for AI-assisted image interpretation or diagnostic systems to evaluate how AI improves human reader performance. The device in question is a lancing device, which provides a blood sample, not an interpretation tool.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a mechanical lancing device, not a software algorithm.

7. Type of Ground Truth Used

• Functional Success / User Proficiency: The ground truth was whether the enrolled lay users could successfully operate the device to "obtain adequate blood volume from fingertip and palm lancing to obtain a numerical or non-numerical result on the BGMS."

8. Sample Size for the Training Set

• Not Applicable. This device is hardware (a lancing device), not an AI/ML algorithm that requires a training set. The "training" for the users in the study was reading the Instructions for Use (IFU).

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

• Not Applicable. See point 8.

Summary Limitations of this Document:

This document is a regulatory clearance letter and 510(k) summary, specifically for a mechanical lancing device. It is not a document for an AI/ML-based diagnostic device. Therefore, it lacks the detailed performance metrics (like sensitivity, specificity, AUC), expert read studies, and training/test set data provenance typically associated with the evaluation of AI/ML algorithms. The "clinical study" described is a usability and safety study for the physical device, demonstrating that lay users can operate it safely and effectively.

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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 Facet Aurora Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting.

The device is designed to be cleaned and disinfected between uses on a single patient.

The Facet Aurora Reuseable Lancet Base is a blood sampling device used in conjunction with a lancet blade of proprietary design to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.

The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.

The provided text describes a 510(k) premarket notification for the "Facet Aurora Reusable Lancet Base." However, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing of its mechanical properties and materials. It does not contain information about:

• Acceptance criteria related to the performance of a device that uses AI/algorithm, such as sensitivity, specificity, or AUC.
• A study proving the device meets acceptance criteria for an AI/algorithm.
• Sample sizes for AI/algorithm test sets or data provenance.
• Details about experts establishing ground truth or adjudication methods for an AI/algorithm's performance evaluation.
• MRMC studies or standalone AI performance.
• Training set details for an AI/algorithm.

The device in question is a mechanical lancing device, not an AI or algorithm-based device. The non-clinical testing listed (e.g., Endcap Removal Force, Depth of Puncture, Life Cycle Test) are standard mechanical and durability tests for such a device.

Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm, as the information is not present. The document focuses on physical and mechanical properties and biocompatibility.

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Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancet holder. It is used with a single use sterile lancet to puncture the skin for collecting capillary whole blood sampled from the fingertip or alternate sites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels of depth. This device is for single user only.

This 510(k) summary is for a lancing device, which is a mechanical device used to obtain blood samples. The document focuses on showing substantial equivalence to existing predicate devices, primarily through non-clinical bench testing. It does not involve AI or human-in-the-loop performance studies. Therefore, many of the requested categories related to such studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily non-clinical bench testing. Therefore, details about sample size (e.g., number of devices tested for mechanical properties) and data provenance (country of origin, retrospective/prospective) for these bench tests are not provided in this summary.

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

This is not applicable as the studies were non-clinical bench tests; there was no "test set" requiring expert ground truth in the clinical sense.

4. Adjudication method for the test set

This is not applicable for the same reasons as point 3.

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 is not applicable. The device is a mechanical lancing device, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a mechanical lancing device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the criteria defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and the device's own internal specifications for functional performance. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for a mechanical lancing device as there are no algorithms being trained.

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

This is not applicable for the same reasons as point 8.

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It is intended to be used with disposable sterile lancets to collect capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. It is for single patient use only.

The lancing device is a mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The lancing device is used with commercially available, sterile, standard square shaft blood lancets.

The lancing device is for use only on a single patient.

I am sorry, but the provided text from the FDA 510(k) notification for the Verifine® Ease Lancing Device, Verifine® Lancing Device does not contain the type of detailed performance criteria and study results you are requesting for a device that typically involves AI or image analysis.

The document describes a lancing device, which is a mechanical tool for collecting blood. It focuses on demonstrating substantial equivalence to a predicate device (Genteel Lancing Device K153670) based on technological characteristics, intended use, and general performance aspects such as:

• Materials: Primarily made from medical-grade plastics.
• Puncture Depth Settings: Comparisons of adjustable depth ranges.
• Reusability: Both are reusable for single-patient use.
• Sterility: Both are non-sterile.
• Shipping and Shelf-Life: Verification of integrity after transportation testing (ASTM D4169) and validation of a 5-year shelf-life / 3000 uses (ASTM F1980-16).

The document explicitly states that the device is a "mechanical blood lancet holder" and its purpose is to "collect capillary blood". There is no mention of AI, image analysis, diagnostic capabilities, or a study involving human readers or expert ground truth adjudication related to disease detection or image interpretation.

Therefore, I cannot provide the information you asked for, such as:

1. A table of acceptance criteria and reported device performance (for AI/image analysis): Not applicable, as this is a mechanical lancing device.
2. Sample size used for the test set and data provenance: No such test set is described for AI performance.
3. Number of experts used to establish ground truth & qualifications: No image-based ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable for AI/image analysis.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The performance testing mentioned in the 510(k) summary is limited to verifying mechanical aspects, shipping integrity, and shelf-life, which are typical for this type of medical device.

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The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.

For use only on a single patient in a home setting.

Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:

(1)TD-5010 Lancing Device

(2) Alternative Site Testing (AST) Cap

The provided text describes the submission for a medical device (TD-5010 Lancing Device and TD-5084 Sterile Lancets) for clearance by the FDA, based on substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System). The document focuses on non-clinical performance testing rather than a clinical study involving human patients or an AI algorithm.

Therefore, many of the requested fields regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and statistical measures for an AI/ML-based medical device are not applicable to this submission as it pertains to a mechanical lancing device and sterile lancets. There is no AI or software component described in this submission.

However, I can extract the acceptance criteria and performance data for the mechanical and material properties of the lancing device and lancets as described in the non-clinical testing summary.

Here's the breakdown based on the provided document:

Device: TD-5010 Lancing Device and TD-5084 Sterile Lancets

Study Type: Non-clinical (bench) performance testing for substantial equivalence. This is not a study proving the efficacy of an AI model.

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing):

Study Details:

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

   • The document describes bench testing of physical devices and components, not a "test set" in the context of an AI/ML algorithm.
   • Specific numbers of devices or lancets tested for each non-clinical test (e.g., how many lancet caps twisted, how many devices dropped) are not explicitly stated. The provenance is implied to be laboratory testing conducted by the manufacturer. It is non-clinical/bench data.

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

   • Not applicable. This is a mechanical device, not an AI model requiring expert ground truth for image interpretation or diagnosis. Ground truth is based on engineering specifications and physical measurements.

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

   • Not applicable. There's no human interpretation or adjudication process described for the device's mechanical performance.

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. No AI component. No human reader study described.

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

   • Not applicable. No AI algorithm.

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

   • For the non-clinical tests, the "ground truth" or reference standards are the engineering specifications, physical measurements, and established testing protocols (e.g., for sterilization, biocompatibility, mechanical forces, and material properties) for lancing devices, often guided by relevant ISO standards (though not explicitly cited for each test, 21 CFR 878.4850 is mentioned).

7. The sample size for the training set:

   • Not applicable. There is no AI component and thus no "training set" in the context of machine learning.

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

   • Not applicable.

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"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"

The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

"Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.

"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"

"Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home.

"Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation.

"Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings.

Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges.

"Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients.

Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use.

The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth.

Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.

The provided document is a 510(k) summary for a medical device (lancing system) seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and performance data.

However, the request asks for details related to a study proving the device meets acceptance criteria specific to AI/Machine Learning models, including expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets.

The provided document does not contain any information about an AI/Machine Learning model. The device described is a physical lancing system for blood collection. Therefore, the requested information regarding AI/ML specific acceptance criteria and study designs (like MRMC, human-in-the-loop, or training/test set ground truth for AI) is not applicable to this submission.

The document discusses non-clinical performance testing (physical, chemical, mechanical properties, packaging integrity, sterilization validation) and biocompatibility testing, which are standard for physical medical devices. It explicitly states: "No clinical study is included in this submission." This further confirms the absence of any data related to AI/ML performance evaluation as specified in your prompt.

Therefore, I cannot populate the table or answer the specific questions about AI/ML model acceptance criteria and study design based on the provided text.

However, I can extract the information that is relevant to the device's acceptance testing as described in the document:

Acceptance Criteria and Device Performance (as per the provided 510(k) Summary for a Lancing System):

Since this is a physical medical device (lancing system) and not an AI/ML model, the "acceptance criteria" and "device performance" relate to physical, chemical, and mechanical properties, not AI metrics like sensitivity, specificity, or AUC. The document states "All tests were verified to meet acceptance criteria" without listing the specific numeric criteria or results for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.

The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.

The provided text describes the Facet Manatee Reusable Lancet Base, a reusable lancing device for obtaining blood samples for diagnostic testing. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested regarding AI/CAD efficacy studies, such as effects on human readers, ground truth establishment for AI models, and training set details, is not applicable or present in this document.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical bench testing performed to ensure the device meets predetermined criteria and satisfies special controls. While specific numerical acceptance values are not provided, the "Importance" column outlines the intended performance. The conclusion states that the tests demonstrate the candidate device is substantially equivalent to the predicate.

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

The document describes non-clinical bench testing. It does not specify a "test set" in the context of patient data or clinical trials, nor does it provide details on sample sizes for each bench test beyond the phrase "non-clinical bench testing was performed." The provenance of this data would be laboratory testing.

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 non-clinical device submission not involving expert review of diagnostic images or interpretations.

4. Adjudication method for the test set:

Not applicable. This is a non-clinical device submission.

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 study was done. This device is a mechanical lancing device, not an AI-assisted diagnostic tool. Clinical testing was deemed "not applicable" as per the document.

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

Not applicable. This device is a mechanical lancing device, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the engineering specifications and performance requirements for the device (e.g., specific force values for button activation, a device functioning after a 1-meter drop). For biocompatibility, the ground truth is established by the relevant ISO 10993 standards and the results from GLP testing, demonstrating the material's biological safety.

8. The sample size for the training set:

Not applicable. This is a non-clinical device submission and does not involve AI/ML training.

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

Not applicable. This is a non-clinical device submission and does not involve AI/ML training.

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LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.

The provided text is a 510(k) summary for the LDE4 Lancing Device. It details the device's technical characteristics and the performance data submitted to support its substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance in distinct metrics like sensitivity, specificity, accuracy, or F1 score, which are common for AI/ML-based diagnostic devices. This document focuses on demonstrating that the lancing device performs its intended mechanical function, is biocompatible, and can be properly cleaned and disinfected.

Based on the information provided, here's a breakdown of the requested elements:

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

The document doesn't provide specific numerical acceptance criteria in the format of a typical diagnostic device performance table (e.g., sensitivity, specificity). Instead, the performance evaluations verify that the device functions as intended and meets safety standards. The "acceptance criteria" are implied by the successful completion and positive results of the various tests.

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 explicitly state sample sizes for each particular test type. For instance, the number of devices or material samples used for biocompatibility or cleaning/disinfection validation is not specified. The studies appear to be prospective bench tests and laboratory evaluations, not clinical trials with human subjects as a "test set" in the context of diagnostic AI. The provenance is implied to be laboratory testing conducted by the manufacturer or its contract labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the provided document. The LDE4 Lancing Device is a mechanical device, and its performance evaluation does not involve establishing ground truth through expert consensus as would be typical for image-based diagnostic AI. The "ground truth" here is objective physical measurements and established biological/chemical testing standards.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretation, which is not relevant for the type of bench testing described for a lancing device.

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. The LDE4 Lancing Device is a standalone mechanical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.

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

This information is not applicable. The LDE4 Lancing Device is a mechanical lancing device, not an algorithm, and therefore does not have "standalone" AI performance.

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

The "ground truth" for the performance described in this document is based on:

• Established physical and chemical standards: For puncture depth measurements, material properties, and mechanical functionality.
• Standardized biological testing methods: For biocompatibility (ISO 10993-1) and virus inactivation efficacy.

8. The sample size for the training set

This information is not applicable. The LDE4 Lancing Device is a mechanical device and does not utilize a "training set" in the context of machine learning or AI.

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

This information is not applicable, as there is no training set for a mechanical lancing device.

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Disposable Sterile 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 single patient use only and should not be shared with anyone else, even a family member.

Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850).

The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device.

The intended users include healthcare personnel, patients and lay users.

The lancet is provided sterile. 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 lancet is 5 years.

This document describes a 510(k) submission for a Disposable Sterile Lancet and Lancing Device. The submission aims to demonstrate substantial equivalence to a predicate device (K220475).

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

1. Table of Acceptance Criteria and Reported Device Performance

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