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droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

droplet® personal lancet is made of steel needle placed inside the plastic body lancet with plastic protective cap.

The lancet remains sterile until the cap is removed. There are two versions of droplet® personal lancets which differ in the needle diameter: 28G and 30G. These two versions differ in lancet body color. The version 28G is available in pink and blue colors, and version 30G is available in violet version.

The provided FDA 510(k) Clearance Letter for droplet® personal lancets outlines the device's technical characteristics and studies performed. However, it does not contain detailed acceptance criteria tables, specific performance metrics, sample sizes, or information typically associated with AI/software-based medical devices (such as clinical study design, ground truth establishment, expert adjudication, or MRMC studies).

The document states: "Clinical data is not required." and focuses on non-clinical performance data for physical device characteristics and compatibility.

Therefore, the following response is based solely on the information available in the provided text, and will highlight what is present while explicitly stating what information is not provided as per the request.

Acceptance Criteria and Study Proving Device Meets Criteria for droplet® personal lancets

The droplet® personal lancets are mechanical medical devices (blood lancets) and as such, the acceptance criteria and study data relate to physical and functional attributes rather than diagnostic or analytical performance metrics typical of AI/software devices. The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests performed and states that "All tests were passed and met the predefined acceptance criteria." However, it does not provide a specific table of these "predefined acceptance criteria" or the quantitative reported performance values. It lists the categories of tests conducted.

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

The document does not specify the sample sizes used for any of the non-clinical performance tests.

• Data Provenance: The tests were conducted internally by HTL-Strefa S.A.'s quality control and presumably in their home country (Poland), as indicated by the company's address. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

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

This information is not applicable/provided. The droplet® personal lancets are physical medical devices, and their performance evaluation relies on engineering, material science, and functional testing, not expert interpretation of outputs like in AI/imaging devices. Ground truth for properties like sharpness or needle protrusion would be established via metrology and physical testing methods, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus ground truth in clinical evaluations, particularly for subjective assessments or borderline cases, which is not relevant to the described non-clinical testing of a lancet.

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

A MRMC study was not conducted and is not applicable. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, typically within imaging or pathology. The droplet® personal lancets are standalone devices used for blood sampling, not for diagnostic interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm was not conducted and is not applicable. This device does not involve an algorithm. The reported non-clinical performance data represents the "standalone" performance of the physical device on its own against specified criteria.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be based on:

• Manufacturer's Predefined Product Specifications: For physical attributes like color, aesthetics, needle presence, orientation, sharpness, and length.
• Engineering/Functional Test Standards: For compatibility with lancing devices (e.g., proper fit, function, retraction).
• International Standards: For biocompatibility (ISO 10993-1) and sterilization (SAL).
• Simulated Environmental Conditions: For transport tests.

It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product and does not involve AI/machine learning, therefore, there is no "training set."

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

This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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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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Disposable Blood Lancet is used for capillary blood sampling.

Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood sampling. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided document is a 510(k) summary for the SteriLance Medical (Suzhou) Inc. Disposable Blood Lancet. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document discusses:

• Regulatory classification: Class II, product code QRK/QRL (Blood Lancets)
• Device description: Single-use, sterile device for capillary blood sampling.
• Comparison to predicate device: Highlights similarities in intended use, sterilization, gauges, components, and materials, with a noted difference in exposed needle length for one model.
• Performance data: Mentions biocompatibility testing (cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity) and non-clinical bench testing (appearance, dimensions, sharpness, binding strength, double needles, empty needle, reverse needle, and compatibility with lancing device).

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them for an AI/ML perspective as this document describes a physical medical device (blood lancet) and not an AI/ML-driven device.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

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Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.

Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.

The SteriLance Medical (Suzhou) Inc. Heel Incision Safety Lancet (SteriHeel 2) underwent various performance tests to demonstrate substantial equivalence to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in quantitative terms for each test. Instead, it lists the types of tests performed to verify substantial equivalence. The reported device performance is that the device verifies or demonstrates performance characteristics and compliance.

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "bench testing performed" for non-clinical data and "biocompatibility evaluation" without detailing the number of units tested.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device is a medical lancet, not an AI or diagnostic imaging device that requires expert review for establishing ground truth. The performance criteria are objective physical and biological properties.

4. Adjudication Method

This information is not applicable, as no expert adjudication was involved in establishing ground truth for the physical and biological performance tests of a medical lancet.

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

No MRMC comparative effectiveness study was mentioned or performed, as this device is a physical medical instrument, not a diagnostic AI system requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study was mentioned or performed, as the device is a physical medical instrument and does not incorporate an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through objective physical measurements, chemical analyses, and biological assays based on recognized international standards and bench testing methods. These include:

• Physical measurements (dimensions, hardness, surface roughness, sharpness)
• Functional tests (puncture function, safety, single-use, cutting depth/width)
• Biocompatibility tests (cytotoxicity, sensitization, systemic toxicity)
• Sterility validation.

8. Sample Size for the Training Set

No training set is referenced or relevant, as this is a physical medical device and not an AI or machine learning model.

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

Not applicable, as there is no training set for this device.

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The ImPress is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.

The provided FDA 510(k) summary for the LetsGetChecked ImPress blood lancing device (K242680) outlines several non-clinical performance studies conducted to demonstrate substantial equivalence to its predicate device (TAP Lancet, K223201). However, it does not include a table of acceptance criteria and reported device performance for the usability study, nor does it provide detailed information regarding the study design elements typically found for a study proving acceptance criteria.

The information provided primarily focuses on the device's technical characteristics and the types of non-clinical tests performed. It mentions usability testing but lacks specific performance metrics or acceptance criteria for that test.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given document. While it states that "Usability Testing was performed to verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device," it does not specify the quantitative or qualitative acceptance criteria for these aspects or the actual performance results against those criteria.

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

For the Usability Testing: The document does not specify the sample size used for this test. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided for the usability testing or any other test. "Ground truth" in the context of usability would typically refer to expert evaluation of user performance or validated criteria for "good" usability.

4. Adjudication method for the test set

This information is not provided.

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

An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This device is a blood lancing device, not an imaging diagnostic tool. Therefore, an MRMC study was not performed, and this question is not applicable.

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

This question is also more relevant for AI/ML-driven diagnostic or assistive devices. As the LetsGetChecked ImPress is a mechanical blood lancing device, it does not involve algorithms or AI. Therefore, a standalone algorithm-only performance study was not performed, and this question is not applicable.

7. The type of ground truth used

For the usability testing, the "ground truth" would likely be defined by a set of pre-established usability goals and criteria, as the device is mechanical and its function is to produce blood samples. The document states the usability testing aimed to "verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device." This implies a combination of:

• Performance-based criteria: Successful production of blood samples.
• Qualitative user feedback: Ease of use and user satisfaction.
• Compliance with instructions: Verification of user comprehension.

However, the specific methods for establishing these "truths" (e.g., expert observation, direct measurement, user questionnaires with pre-defined success rates) are not detailed.

8. The sample size for the training set

This question is applicable to devices involving machine learning or AI. As the ImPress is a mechanical device, there is no training set in the context of AI/ML.

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

As there is no training set (see point 8), this question is not applicable.

Summary of what is available and what is missing:

The document lists several non-clinical studies conducted (Shelf-life, Transport, Biocompatibility, Usability, Accidental Drop) and states their purpose (confirm specifications, intended use, substantial equivalence). For the Usability Testing, it broadly describes the goals (user comprehension, ability to produce samples, ease of use, satisfaction). However, it lacks the specific quantitative or qualitative acceptance criteria and the detailed results of these tests, which would directly "prove" the device meets acceptance criteria. Furthermore, details regarding sample sizes, ground truth establishment, expert involvement, and adjudication methods for the usability study are not provided in this specific FDA letter and summary.

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It is intended for capillary blood sampling.

The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through irradiation. The product has a shelf life of 3 years.

The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling.

The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.

The provided document is a 510(k) Premarket Notification for medical devices, specifically blood lancets. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets novel acceptance criteria.

Therefore, the information typically requested in your prompt regarding acceptance criteria, performance reports, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable or directly available in this specific document.

This document primarily compares the technical specifications and non-clinical test results of the new devices (Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus) to a legally marketed predicate device (VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, and Promisemed Blood Lancet, K221368) to establish that they are "substantially equivalent."

Here's a breakdown of why some of your requested information isn't present:

• Acceptance Criteria and Performance Report (Table 1): The document doesn't provide a table of novel acceptance criteria for a new device and its performance against those. Instead, it compares features of the submitted devices to a predicate device and states that non-clinical tests (sterilization, shelf-life, biocompatibility, and performance testing) were conducted and met regulatory requirements and safety standards.
• Sample Size for Test Set and Data Provenance: The document explicitly states "Clinical performance testing was not deemed necessary as the non-clinical testing was sufficient to demonstrate substantial equivalence." Therefore, there is no clinical "test set" in the context of human data. The non-clinical tests (sterilization, shelf-life, biocompatibility, and performance) would have their own sample sizes, but these are not detailed in the summary.
• Number of Experts, Qualifications, and Adjudication Method: Since no clinical data or image-based studies are presented, these details are irrelevant.
• MRMC Comparative Effectiveness Study: Not applicable, as no clinical study comparing human readers with and without AI assistance was conducted or described.
• Standalone Performance: While non-clinical performance tests were done on the devices themselves, this is not "standalone performance" in the context of an AI algorithm operating without human intervention.
• Type of Ground Truth Used: Not applicable. There's no clinical "ground truth" established as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established standards and specifications for performance, sterility, etc.
• Sample Size for Training Set and How Ground Truth was Established (for Training Set): Not applicable, as this is related to AI/machine learning models, which are not described in this submission for blood lancets.

In summary, the provided document focuses on demonstrating substantial equivalence of a physical medical device (blood lancet) through comparison to a predicate device and non-clinical bench testing, not on clinical performance studies involving human data or AI algorithms.

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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 gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.

The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed incision device for acquiring blood samples from the patient's finger to obtain sufficient blood volumes for capillary blood draws. The gentleheel Adult Incision Device utilizes a blade resulting in improved blood flow requirements. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with a human fingertip. The user is instructed to remove the trigger lock. When the gentleheel Adult Incision Device is placed against the patient's finger and the user presses the trigger mechanism it automatically makes the incision the blade in a continuous motion from inside the housing, into the fingertip, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel Adult Incision Devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The provided text describes the 510(k) premarket notification for the gentleheel® Adult Incision Device (K242664), which is a single-use lancing device. This device is an additional indication for use of the previously cleared gentleheel® device (K220917 and K172712).

Here's an analysis 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 acceptance criteria are inferred from the summary of testing mentioned. The document focuses on demonstrating substantial equivalence to a predicate device, and thus the performance is reported in the context of meeting safety and functional requirements.

2. Sample Sizes and Data Provenance for Test Set

• Sample Size for the test set: Not explicitly stated in terms of number of participants for the clinical use testing. It only mentions "clinical use testing was completed on adults."
• Data Provenance: The document does not specify the country of origin for the data. The clinical use testing for the adult indication was "completed on adults." It appears to be a prospective study for a specific cohort (adults) to expand the indication of use.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the document. The studies mentioned are primarily performance and clinical use trials, not studies relying on expert consensus for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• This information is not applicable and is not provided in the document. The studies described are performance and clinical use studies for a lancing device, not studies requiring adjudication among experts for a diagnostic output.

5. MRMC Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typically for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a lancing device, not an imaging or diagnostic AI-powered device.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. This device is a mechanical lancing device, not an AI algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the clinical use testing was the successful collection of microliter capillary blood samples from adults via fingertip lancing, and confirmation that the device's sharps prevention feature functioned as intended. For the performance tests, the ground truth would be adherence to defined engineering specifications (e.g., cutting profile dimensions, trigger force, structural integrity post-drop, and proper function of the sharps prevention feature).

8. Sample Size for the Training Set

• This information is not applicable as this device is a mechanical lancing device and does not involve machine learning or an "algorithm" requiring a training set.

9. How Ground Truth for Training Set was Established

• This information is not applicable as there is no training set for this mechanical 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 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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