Search Results

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.

Ask a specific question about this device

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.

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

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

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

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

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet.

The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19

The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G

This is a 510(k) premarket notification for a medical device called the RightLance Blood Lancing System. The document focuses on establishing substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System, rather than providing a detailed study that proves the device meets specific acceptance criteria as one might find for an AI/ML powered device.

Therefore, many of the requested elements for AI/ML device studies (like effect size for MRMC studies, training set details, or complex ground truth establishment) are not applicable to this type of submission.

Here's an analysis based on the provided text, focusing on what is relevant for a non-AI medical device submission:

Acceptance Criteria and Device Performance

There isn't a table of quantitative performance acceptance criteria in the typical sense of measuring algorithm accuracy (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the comparison to the predicate device and compliance with recognized international standards and internal design specifications. The device is accepted if it performs "as well as or better than" the predicate device and meets its own design specifications.

The comparison table provided (page 4) details the technological characteristics, highlighting similarities and differences with the predicate.

Table of Acceptance Criteria (Implied by Predicate Comparison and Standards) and Reported Device Performance

Study Details (as applicable)

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

   • No "test set" in the context of an AI/ML algorithm evaluation.
   • For the non-clinical bench testing, the sample sizes are not specified in the provided summary.
   • Data provenance: Not applicable for this type of device where laboratory bench testing is the primary evidence.

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

   • Not applicable. There is no "ground truth" establishment by experts for this type of mechanical lancing device. The performance is assessed against engineering specifications and international standards.

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

   • Not applicable. No expert adjudication process is described or relevant for this device.

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:

   • No. This is not an AI/ML powered device, so MRMC studies are not relevant.

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

   • Not applicable. This is a manual mechanical device, not an algorithm. The non-clinical tests assess the device's physical and functional performance directly.

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

   • For this device, "ground truth" would be defined by engineering specifications, international standards (e.g., ISO, USP), and the performance characteristics of the predicate device. For example, a "puncture depth" test would have an expected range based on design, and the device's output would be measured against that.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable. No training set.

Ask a specific question about this device

The OneTouch® Delica® Plus lancets are sterile, single use devices that have been designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The OneTouch Delica Plus lancets are compatible with the single patient use OneTouch® Delica® Plus lancing device.

The OneTouch® Delica® Plus Lancing System consists of a non-sterile, reusable base blood lancing device that is intended for use on a single patient and is used in conjunction with a sterile, single-use lancet. The lancing device has 13 depth settings. The lancets are made available in size 30G and are packaged in boxes of 30 and 100 count.

This device is a OneTouch® Delica® Plus Lancing System, which is a blood lancing system for obtaining capillary blood samples from the fingertips. This submission is for a 510(k) premarket notification, which means it evaluates substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" are demonstrating substantial equivalence through non-clinical performance testing.

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

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are the successful completion of various non-clinical performance tests to demonstrate that the device is as safe and effective as the predicate. The reported device performance is that it met the specifications for each test.

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

The document does not specify the exact sample sizes used for each non-clinical test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, though it would be prospective for these types of verification and validation tests.

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

This information is typically not applicable to non-clinical performance testing of a lancing device. The "ground truth" here is objective measurements and adherence to established standards and specifications, not expert interpretation.

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

Not applicable to non-clinical performance 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

Not applicable. This device is a blood lancing system, not an AI software. No MRMC study was performed.

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

Not applicable. This device is hardware, not an algorithm.

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

For the non-clinical performance tests, the "ground truth" refers to the established technical specifications, quality standards (e.g., ISO, ASTM), and regulatory requirements that the device must meet. The tests themselves provide objective data to verify compliance with these standards.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

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

Ask a specific question about this device

The Accu-Chek FastClix Blood 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. upper arm, and the forearm. Six sterile, sincets are in a drum. The lancet drum is to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The Accu-Chek FastClix Lancing Device uses compatible Accu-Chek FastClix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek FastClix Blood Lancing System consists of three components: 1. Accu-Chek FastClix Lancing Device 2. Accu-Chek FastClix Lancets 3. Accu-Chek FastClix Alternative Site Testing (AST) Cap

This document is a 510(k) premarket notification decision letter from the FDA for the Accu-Chek FastClix Blood Lancing System. It declares the device substantially equivalent to a predicate device.

The provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML powered device. The device described is a mechanical blood lancing system for capillary blood collection, not an AI/ML system.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for an AI/ML system).
• Sample size and data provenance for a test set (for an AI/ML system).
• Number and qualifications of experts for ground truth (for an AI/ML system).
• Adjudication method (for an AI/ML system).
• MRMC comparative effectiveness study details (for an AI/ML system).
• Standalone performance details (for an AI/ML system).
• Type of ground truth used (for an AI/ML system).
• Sample size for the training set (for an AI/ML system).
• How ground truth for the training set was established (for an AI/ML system).

The document explicitly states: "Clinical Testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately." This further confirms that no clinical study, of the type relevant to AI/ML device performance validation, was conducted or required for this mechanical device.

The "Nonclinical bench testing" mentioned refers to mechanical and validation testing related to sharps injury prevention and mechanical functions, not AI/ML performance.

Ask a specific question about this device

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

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The Accu-Chek Softclix Lancing Device uses compatible Accu-Chek Softclix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek Softclix Blood Lancing System consists of three components:

1. Accu-Chek Softclix Lancing Device
2. Accu-Chek Softclix Lancets
3. Accu-Chek Softclix Alternative Site Testing (AST) Cap

The provided text describes the regulatory clearance of a blood lancing system and focuses on the substantial equivalence to a predicate device, rather than detailed acceptance criteria and a study proving those criteria.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted as they are not present in this regulatory document. This document emphasizes non-clinical (bench) testing to ensure functional equivalence and risk mitigation for a medical device.

However, based on the information provided, here's what can be extracted and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. It states that "Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device." This implies that the device met certain mechanical and safety standards but doesn't list specific quantitative criteria or their outcomes.

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

This information is not provided in the document. The text only mentions "nonclinical bench testing" and "design verification testing" without specifying sample sizes for these tests or the origin of the 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 information is not applicable and not provided. As this is a mechanical blood lancing device, "ground truth" in the context of expert review for diagnostic accuracy is not relevant. The testing focuses on mechanical function, safety, and performance as a lancing device.

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

This information is not applicable and not provided. Adjudication methods are typically associated with qualitative or diagnostic assessments, which are not the focus of this device's testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or AI-assisted diagnostic devices. This device is a blood lancing system, which does not involve human readers interpreting AI results.

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

This information is not applicable and not provided. The device described, a blood lancing system, does not involve an algorithm for standalone performance assessment in the way AI systems do. Its performance is mechanical and safety-related.

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

The document explicitly states: "Clinical Testing is not applicable: risk analysis confirmed that all identified risks were addressed and mitigated appropriately." Therefore, ground truth, as often defined for diagnostic accuracy, was not established through clinical data, pathology, or expert consensus on patient outcomes. Instead, the "ground truth" for this device's performance would be adherence to engineering specifications, safety standards (e.g., sharps injury prevention), and mechanical functionality confirmed through bench testing.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/ML device that requires training data.

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

This information is not applicable and not provided, as there is no training set mentioned for this device.

Ask a specific question about this device