Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel. The Accu-Chek Safe-T-Pro Plus lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Plus lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only. It has a 23 Gauge needle with 3 depth levels by twisting cap: 1.3 mm, 1.8 mm, 2.3 mm. It is spring-driven and loading/priming is not required. Press release button to activate lancet mechanism.

The provided text is a 510(k) premarket notification for the "Accu-Chek Safe-T-Pro Plus Lancing Device". It focuses on establishing substantial equivalence to predicate and reference devices rather than presenting specific acceptance criteria and a detailed study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML devices.

However, based on the information provided, I can extract the non-clinical testing performed and infer the acceptance criteria and details about the study.

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

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

The document does not explicitly state numerical acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for comparison within a table, as one would expect for an AI/ML device. Instead, it describes "nonclinical bench testing" and "design verification and validation testing" to ensure risk management and mechanical function. The "reported device performance" is broadly stated as "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

However, we can infer acceptance criteria related to safety and functionality from the types of testing mentioned and the characteristics of the device.

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 primarily describes non-clinical bench testing. It does not provide details on a "test set" in the context of clinical data for performance metrics. For the "nonclinical bench testing," the sample size of devices tested is not specified. The data provenance is also not specified, but it would typically be internal testing conducted by the manufacturer. Since it's bench testing, concepts of retrospective or prospective data usually don't apply in the same way as clinical studies.

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 section is not applicable as the document describes a physical medical device (lancing device) and its mechanical and safety performance, not an AI/ML algorithm that requires expert-established ground truth for a test set. There is no mention of experts or ground truth in this context.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies involving interpretation of data, often by multiple readers, which is not the case here.

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 section is not applicable. The device is a "lancing device," a physical tool for blood sampling. It does not involve AI or software for diagnostic interpretation, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely outside the scope of this device.

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

This section is not applicable as the device is a lancing device and does not involve any algorithm or software with standalone performance.

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

This section is not applicable. For a lancing device, the "ground truth" for its performance would be its physical properties, sterility, mechanical reliability, and safety features, which are evaluated through engineering tests and quality control, not clinical "ground truth" like pathology or outcomes data in the sense of diagnostic accuracy.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML product and does not have a "training set."

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The provided text is an FDA 510(k) premarket notification for the Accu-Chek Safe-T-Pro Uno Lancing Device. It does not describe a study with acceptance criteria in the manner typically found in clinical trials or AI/software validation studies. Instead, it details a "non-clinical bench testing" approach to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance for specific metrics. Instead, it refers to "design verification and validation testing" performed per "applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)." The conclusion states the device "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

The closest approximation to "device performance" mentioned is:

• The Accu-Chek Safe-T-Pro Uno lancing device is designed for a single use only and has a sharps injury prevention feature where the lancet is retracted and concealed before and after use, and is rendered inoperative after use.
• It uses a 28 Gauge needle with a 1.5 mm depth and is spring-driven.
• Loading/priming is not required; activation is via a press release button.

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

The document does not specify a "sample size used for the test set" or "data provenance" in terms of subject populations or data collection methods (retrospective/prospective). This is because the described testing is "non-clinical bench testing," meaning it was likely conducted in a laboratory setting on the device itself, rather than on human subjects or clinical data.

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

This is not applicable as no "ground truth" established by experts for a test set is mentioned. The testing involves mechanical and design verification, not expert evaluation of results from human or image data.

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

Not applicable. No adjudication method is mentioned as there's no expert review of outcomes.

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. A MRMC comparative effectiveness study is relevant for AI or diagnostic imaging devices evaluating human performance. This document is for a medical device (lancing device) and does not involve AI or human readers.

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

Not applicable. This is not an AI or algorithm-based device.

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

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical bench testing would be engineering specifications, regulatory standards (like ISO or FDA special controls for sharps injury prevention), and the performance characteristics of the legally marketed predicate and reference devices.

8. The sample size for the training set

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

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

Not applicable. This is not an AI/machine learning device.

Summary of what is present:

• Type of Study: Non-clinical bench testing (design verification and validation testing).
• Purpose: To demonstrate the mechanical functions, safety (sharps injury prevention), and performance are suitable for use and are substantially equivalent to legally marketed predicate and reference devices.
• Applicable Standards: FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850).
• Conclusion: The device is "safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices."
• Clinical Testing: "Not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately."

Ask a specific question about this device

The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.

The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet. The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs. The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed. If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap. The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry. The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them relate to a Class II medical device, the EasyTouch Lancing Device, which is used for collecting capillary blood samples. The document is a 510(k) Premarket Notification from the FDA, focusing on the substantial equivalence of the new device to a legally marketed predicate device.

It's crucial to understand that for a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove absolute efficacy or safety through rigorous clinical trials as would be required for a "PMA" (Premarket Approval) device. Therefore, the "acceptance criteria" and "study" described herein are tailored to this regulatory pathway.

Here's a breakdown of the requested information:

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

The document describes non-clinical bench testing for mechanical design verification and validation, as well as biocompatibility. The "acceptance criteria" are implied by the performance of the predicate device and the adherence to special controls and specified requirements. "Reported device performance" is given as meeting these criteria.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical bench tests (e.g., how many lancing devices were drop-tested, or how many samples for biocompatibility). It generally states that "non-clinical bench testing was performed" and "a battery of tests" for biocompatibility.
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer (STAT Medical Devices). The location/country of origin of this specific testing is not explicitly stated, but it's part of a U.S. FDA 510(k) submission. The testing is assumed to be prospective as it was conducted specifically for this premarket submission.

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

• This information is not applicable in the context of this 510(k) submission for a lancing device. Ground truth established by expert consensus (e.g., radiologists interpreting images) is typically relevant for interpretative devices like AI algorithms for diagnostics, not for mechanical devices like lancing devices. The "ground truth" for the performance of this device is based on objective, quantifiable physical and material properties (e.g., piercing depth measurement, force measurement, chemical reactivity).

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting data (e.g., medical images) to resolve discrepancies and establish a consensus "ground truth." For the mechanical and biocompatibility testing of a lancing device, the results are objectively measured or observed, and therefore do not require human adjudication in this manner.

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. An MRMC study is designed to evaluate the performance of diagnostic systems (often involving AI) and human readers. The EasyTouch Lancing Device is a mechanical blood collection device, not an interpretative diagnostic device or AI algorithm.

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:

• The "ground truth" for the non-clinical testing of the EasyTouch Lancing Device is primarily established through objective engineering measurements, physical property testing, and established laboratory standards for biocompatibility. This is in contrast to "expert consensus" or "pathology" which are typically used for diagnostic devices. For example, "piercing depth" is measured directly, not subjectively interpreted.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning models (AI). The EasyTouch Lancing Device is a mechanical device, not an AI or machine learning product.

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

• This is not applicable as there is no AI training set for this mechanical device.

Ask a specific question about this device

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.

Ask a specific question about this device

The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.

The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet. The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.

The provided documentation describes the One Drop Lancing Device, which is intended for collecting capillary blood from the fingertip for testing purposes in a home setting. The document confirms that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document explicitly states that "Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied." It also mentions "mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements."

While the document indicates that these criteria were met, it does not provide a specific table detailing the acceptance criteria values and the device's measured performance against each. It only lists the types of tests conducted.

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

The document does not specify the sample sizes used for the non-clinical bench tests. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective) as the testing described is non-clinical bench testing, not clinical human studies.

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

Since the testing described is non-clinical bench testing of a mechanical device, the concept of "experts used to establish the ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable. The "ground truth" would be the engineering specifications and regulatory requirements, and the tests were performed by engineers/technicians in a lab setting.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical bench testing against engineering specifications, not a clinical study requiring adjudicated interpretations.

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 to the One Drop Lancing Device. This device is a mechanical lancing device, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

This is not applicable to the One Drop Lancing Device, as it is a mechanical device without an algorithm.

7. The type of ground truth used:

The ground truth for the non-clinical testing of the One Drop Lancing Device can be inferred as:

• Engineering specifications and design requirements: For dimensional measurements, function reliability, piercing depth, and cock force.
• International standards (ISO 10993-1): For biocompatibility.
• Regulatory Special Controls (21 CFR 878.4850): For overall regulatory compliance.

8. The sample size for the training set:

Not applicable, as there is no "training set" for a mechanical lancing device; it does not involve machine learning or AI.

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

Not applicable, as there is no "training set."

Summary of the Study:

The study was a series of non-clinical bench tests conducted to evaluate the mechanical performance, safety, and compatibility of the One Drop Lancing Device. These tests aimed to ensure the device met predetermined engineering specifications, international standards (ISO 10993-1 for biocompatibility), and regulatory special controls (21 CFR 878.4850). The tests included:

• Dimensional measurements
• Function reliability drop test
• Piercing depth test
• Cock force test
• Biocompatibility testing
• Compatibility with One Drop branded Lancets (by reference to K221383)

The document concludes that "The intended use, technology, non-clinical testing, and functionality of the One Drop Lancing Device demonstrate a substantially equivalent safety and effectiveness profile to the predicate device."

Ask a specific question about this device

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.

Ask a specific question about this device

"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

Ask a specific question about this device