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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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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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Lancet is intended for capillary blood sampling.

The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites. The shelf-life of the product is 5 years.

The provided document is a 510(k) premarket notification for a medical device (Sterile Lancets for Single Use). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

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 document does not explicitly list "acceptance criteria" with numerical targets in a formal table corresponding to performance. Instead, it refers to "Performance testing is conducted according to Inspection Specification" and states that "the test sample has undergone accelerated aging for 5.5 years" and "passed all tests." The performance attributes tested are listed.

Here's an interpretation of the performance attributes and the implied acceptance criteria from the text:

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

• Sample Size for Test Set: The document does not specify the numerical sample size used for performance testing. It generally refers to "the test sample."
• Data Provenance: The document indicates that the testing was conducted by Ningbo Caremed Medical Products Co., Ltd., based in China. The data would be retrospective in the sense that the tests were completed before the 510(k) submission.

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

This information is not applicable as the device is a medical lancet and the testing involves objective physical, chemical, and biological performance tests, not subjective interpretation by experts to establish a "ground truth" like in imaging or diagnostic AI. The "ground truth" for these tests would be the established scientific and engineering standards and methods.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used when subjective expert opinion is involved in ground truth establishment.

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

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a sterile lancet for single-use capillary blood sampling, a physical instrument, and does not involve human readers interpreting output that would be improved by AI assistance.

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

This information is not applicable. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing of the lancet is based on:

• Established scientific and engineering standards: For dimensions, firmness, puncture performance, matching, launch performance.
• Specific ISO standards: For biocompatibility (ISO 10993 series) and sterilization (SAL of 10-6).
• Bacterial endotoxin limits: Established regulatory or compendial limits.
• Accelerated aging protocols: To simulate real-time shelf-life.

8. Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

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

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The disposable MICROLET®NEXT Lancet is used for capillary blood collection.

The disposable MICROLET®NEXT Lancet is used for capillary blood collection. The device comprises of a stainless needle encapsulated with a plastic and protective cap; the protective cap is twisted off to expose the needle for use. The device is sterilized by radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided text describes a 510(k) premarket notification for a medical device, the MICROLET®NEXT Lancet, which is used for capillary blood collection. It is a Class II device. The document mostly focuses on demonstrating substantial equivalence to a predicate device (STERILANCE DISPOSABLE BLOOD LANCET, K221507) and regulatory compliance.

However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI/Software as a Medical Device (SaMD).

The document discusses non-clinical and clinical tests, but these are related to the physical performance of a lancet (biocompatibility, usability, shelf life, and the ability to obtain adequate blood volume for a blood glucose monitor), not the performance of an AI or software algorithm.

Therefore, I cannot extract the following information that would be relevant to an AI/SaMD study:

1. A table of acceptance criteria and the reported device performance (for an AI/SaMD): Not present, as this is not an AI/SaMD.
2. Sample sizes used for the test set and the data provenance: A clinical study "enrolled 131 lay persons with diabetes" and "120 completed the study." This is a sample size for a human-use study of a physical device, not an AI test set. Data provenance is not specified beyond "a single clinical site."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lancet isn't established by experts in the same way it is for an AI interpreting medical images. The "ground truth" here is whether the lancet can obtain a sufficient blood sample for a BGMS.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating human performance with and without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the lancet's performance is the ability to obtain "adequate blood volume from fingertip and palm lancing to obtain a numerical result on the BGMS."
8. The sample size for the training set: Not applicable, as this is not an AI.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a physical medical device (a lancet) and not an AI/SaMD. Therefore, the specific details regarding acceptance criteria, test set, ground truth, and study design relevant to an AI/SaMD are not present.

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

2. Sample Size for the Test Set and Data Provenance

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

3. Number of Experts and Qualifications for Ground Truth

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.

The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma radiation, which is a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger to get a blood sample. The SG LANSET I, SG LANCETS and SOFT LANCETS can be used anytime and anywhere to obtain a blood sample form diabetic patients to measure their blood sugar level. A cap is included to protect the needle from becoming contaminated with dust, etc. The cap completely seals the needle making it impossible for any foreign material to come in contact with the needle. This ensures safe storage and easy portability.

The lancing device used with most blood lancets, offers an adjustable tip with variety depth settings for quick, comfortable and easy blood sampling.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the requested details (table, sample size, experts, etc.).

The provided document is a 510(k) summary for a medical device (blood lancets). While it discusses substantial equivalence to predicate devices and lists types of performance tests (Dimension, Inner-Outer surface, Draw test, Biocompatibility, Sterilization, Shelf-Life), it does not provide specific acceptance criteria or detailed results of these tests. For example, it states "Dimension: Pass" but doesn't specify what the dimensional requirements were. It also explicitly states, "This 510(k) does not include data from clinical tests."

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or multi-reader studies, as that information is not present in the provided text.

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Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are for single patient use in a home setting.

The Stat Medical Lancing Device Systems consist of two types of lancing devices: ULTIMATE Lancing Device and TRIO Lancing Device. Both are single-person, multiple-use devices made of ABS plastic and SUS304 stainless-steel springs. The ULTIMATE has 8 depth-setting choices, and the TRIO has 5 depth-setting choices and a Lancet Ejector. The systems also consist of two types of representative (generic) lancets: COMFORT THIN Twist-Off Lancets and COMFORT THIN Pull-Off Lancets. Both are sterile, single-person, single use devices made of plastic with a SUS304 stainless-steel needle tip and a protective plastic cover. The ULTIMATE and TRIO Lancing Devices have optional Alternative Site Test (AST) Caps.

The provided text is a 510(k) summary for the "STAT Medical Lancing Device Systems." It discusses the device's intended use, technological comparison to predicate devices, and results of non-clinical testing. However, it explicitly states that clinical testing was not applicable and therefore, it does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance metrics such as reader studies or algorithm performance.

The document mainly focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance (mechanical testing and biocompatibility).

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study that proves the device meets the acceptance criteria in the context of clinical performance (like a multi-reader multi-case study, standalone algorithm performance, or human-in-the-loop improvement) because such information is not present in the provided text.

The information that is available and can be extracted relates to the acceptance criteria for non-clinical performance tests.

Non-Clinical Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion and compliance with the listed ISO standards and the performance tests. The reported performance indicates that the device met these criteria.

Regarding the specific points asked for in the prompt, based on the provided text:

1. A table of acceptance criteria and the reported device performance: See table above, derived from the "Non-clinical Testing Summary and Conclusions" and the "Similarities and Differences" table.
2. Sample sized used for the test set and the data provenance:
   • Sample Size: For "Range of Depth (mm)" and "Range of Depth + AST Cap (mm)" measurements, a sample size of 30 samples is explicitly mentioned for both the Ultimate and TRIO Lancing Devices. For other mechanical tests (Pen testing, cock force, insertion force, removal force, migration distance), sample sizes are not explicitly stated but are implied to be sufficient for compliance.
   • Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. These are non-clinical lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is about a lancet device, not an AI/imaging device requiring expert ground truth for image interpretation. The testing performed is mechanical and biocompatibility, which does not involve human expert interpretation as ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no expert adjudication process described for the mechanical or biocompatibility testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. The device is a lancing system, not an AI-assisted diagnostic tool. Clinical testing was explicitly stated as "not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The device is a lancing system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For mechanical tests, the "ground truth" is adherence to engineering specifications and performance within defined ranges. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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SafeLan® is sterile, single use device that has been designed for single patient use by lay users in a home. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples.

SafeLan®-Pro: Use with SafeLan® for capillary blood sampling and the SafeLan®-Pro as the multiple use execution device which the SafeLan® lancet attaches.

SafeLan® blood lancet is a small medical device used for capillary blood sampling. The SafeLan® is a blood lancet consisting of protective cap, needle protector, spring, lancet, and needle. The main component of blood lancet is the small, sharp objects that are used to prick the skin to obtain a small quantity of blood for testing. SafeLan® has 2 models depending on the diameter of the needle.

• SafeLan® 26G: 0.46±0.05mm
• SafeLan® 30G: 0.30±0.05mm

Lancing device (SafeLan®-Pro) combines with the SafeLan® to operate the needle to prick the skin.

SafeLan®-Pro is used with SafeLan® to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. SafeLan® is used with compatible lancing device (SafeLan®-Pro) for capillary blood sampling.

Safel an 9-Pro consists of loading handle, operation button, depth adjustment confirmation part.

The operating principle of SafeLan®-Pro is driven by force of the simple operating sequence is as follows.

1. Insert the SafeLan® clockwise to the front thread of the SafeLan®-Pro.

2. Pull the needle protector of SafeLan® to remove it.

3. Pull and release the loading handle of SafeLan®-Pro.

4. Press the operation button of SafeLan®-Pro.

5. Remove the used SafeLan® from the SafeLan®-Pro by turning them counterclockwise.

It appears the provided document is a 510(k) Premarket Notification from the FDA regarding a medical device, SafeLan®.

However, the provided text does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, specifically regarding an AI/ML algorithm. The document primarily focuses on the device description, intended use, and a comparison to a predicate device for substantial equivalence, as is typical for a 510(k) submission for a physical medical device (blood lancets).

The questions posed (e.g., sample size for test set, data provenance, number of experts, MRMC study, standalone performance, ground truth) are highly relevant to the evaluation of AI/ML-enabled medical devices. Since SafeLan® is a physical blood lancet and lancing device, an AI component is not implied or mentioned in this regulatory document.

Therefore,Based on the provided text, I cannot answer the questions as they pertain to an AI/ML algorithm's acceptance criteria and performance study. The document is about a mechanical blood lancet, not an AI/ML device.

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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.

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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."

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