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The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.

The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.

The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.

We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.

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

The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.

• Sample Size: 120 patients enrolled.
  • 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
  • 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
• Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.

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

• This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

• This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.

8. The Sample Size for the Training Set

• This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.

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

• This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this device.

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The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex.

Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body.

The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.

IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw

This document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the Neobiotech IS-III active System S-narrow Type dental implant system to legally marketed predicate devices.

This document describes a premarket notification for a dental implant system. It does NOT contain information about an AI/ML-driven medical device or a study involving human-in-the-loop performance, expert consensus, or ground truth establishment for a test set.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this document does not pertain to such a device or study.

The provided document focuses on:

• Device Description: What the dental implant system is composed of (fixtures, abutments, screws), materials used (Titanium ELI), dimensions, and surface treatments.
• Indications for Use: Where and how the device is intended to be used in dental procedures.
• Substantial Equivalence Comparison: A detailed comparison of the subject device (IS-III active System S-narrow Type) with various predicate devices (both primary and reference predicates) across technological characteristics such as device name, classification, materials, design, dimensions, surface treatment, sterilization, and principle of operation.
• Non-Clinical Testing Data: A list of performance tests conducted on the subject device (e.g., sterilization validation, shelf life, bacterial endotoxin) and tests leveraged from predicate devices (e.g., biocompatibility testing). The conclusion states that these tests met the criteria of the standards and demonstrated substantial equivalence.

Without information on an AI/ML component or a clinical study that evaluates its performance against acceptance criteria using a human-in-the-loop or standalone approach, I cannot fulfill the request for the specific points listed.

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The IT-III active system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.

The provided text describes the Neobiotech Co., Ltd. IT-III active System, an endosseous dental implant system, and its substantial equivalence to predicate devices, but does not contain a study comparing the device's performance against specific acceptance criteria and reporting its performance metrics in a way that directly answers all the questions in the prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to already legally marketed devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the format requested.

However, I can extract the information provided that is relevant, or indicate where the information is not present.

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 in the requested format. Instead, it states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device did meet the criteria of the standards listed, but doesn't quantify the performance against those criteria.

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 lists non-clinical testing performed, such as Fatigue Testing, Sterilization Testing, Shelf Life Testing, Bacterial Endotoxin Test, and Biocompatibility Evaluation. However, it does not specify the sample sizes used for these tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 type of information is not applicable to the non-clinical testing (fatigue, sterility, etc.) described in the document. Ground truth as typically established by experts (e.g., radiologists for imaging studies) is not relevant for the engineering and biological tests conducted for dental implant device clearance.

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

This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, which is not the nature of the tests performed here.

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

No MRMC comparative effectiveness study was performed or mentioned in this document. This study type is far more common for diagnostic imaging AI devices, rather than for a dental implant system.

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

This concept is not applicable to the IT-III active System, which is a physical dental implant. Standalone algorithm performance refers to the performance of AI software independent of human intervention, which is not relevant for this device.

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

For the non-clinical tests conducted, the "ground truth" is defined by the standards themselves (e.g., ISO 14801 specifies the methodology and interpretation for fatigue failure, ISO 11137 for sterility). The tests measure whether the device meets the predefined physical, mechanical, and biological properties as stipulated by these recognized standards. It's not about an expert diagnosis or clinical outcome but rather adherence to engineering/material specifications.

8. The sample size for the training set

No training set is mentioned or applicable. This document is not describing a machine learning or AI algorithm, but rather a physical dental implant device undergoing non-clinical validation.

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

Not applicable, as there is no training set described.

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The IS-III active System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and terminal or internediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). There are 4 types of fixtures in this system and the dimensions are as following: Tolerance of dimension shall be within ± 1% range. IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw. The dimensions of abutments are as following: Tolerance of dimension for Abutments shall be within ± 1% range. The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated. IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized. IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap. All of above products including enclosed product are packed separately for convenience.

The provided document is a 510(k) Premarket Notification for a dental implant system. It outlines the characteristics of the IS-III active System and compares it to predicate devices to demonstrate substantial equivalence, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for an AI/ML powered device.

Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not present in this document.

However, I can extract information related to the device's non-clinical testing and comparison to acceptance criteria (standards).

Here's the closest representation of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for the Neobiotech IS-III active System (K181138)

This 510(k) submission establishes the substantial equivalence of the IS-III active System to legally marketed predicate devices primarily through comparison of technological characteristics and non-clinical performance testing against recognized standards. The acceptance criteria are derived from these international and internal standards, and the device's performance data is reported as meeting these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Specific sample sizes for each non-clinical test (e.g., number of implants for fatigue testing or biocompatibility animal models) are not detailed in this summary document.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data nor if it was retrospective or prospective, as these are typically not relevant for non-clinical bench or lab testing. The testing was conducted to international and US FDA recognized standards.

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 as the document describes non-clinical engineering and biological tests conducted against established standards, not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context.

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

This information is not applicable as the document describes non-clinical engineering and biological tests.

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. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.

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

This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.

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

For biocompatibility and mechanical testing, the "ground truth" is defined by the established criteria and methodologies within the cited international ISO and ASTM standards, as well as the FDA guidance document. For example, for fatigue, the "ground truth" is that the device must withstand a certain number of cycles at a specified load without failure, as per ISO 14801.

8. The sample size for the training set

This information is not applicable. This document is for a physical medical device. There is no AI/ML algorithm or "training set" involved in its development or evaluation as described here.

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

This information is not applicable. No training set is mentioned or relevant to the information provided in this 510(k) summary for a physical dental implant.

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The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf and palm.

Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase

Here's an analysis of the provided text regarding the Accu-Chek Active System's acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary focuses on demonstrating that the modified Accu-Chek Active System maintains its accuracy when used with alternate sampling sites (palm) compared to fingertip measurements, and that its performance for existing alternate sites (calf, thigh, upper arm) remains consistent.

Acceptance Criteria for Correlation (Implicit): The study aimed to demonstrate a "substantial correlation (r > 0.90)" between AST (Alternate Site Testing) results and finger results.

Reported Device Performance:

Conclusion regarding acceptance criteria: Both palm sampling sites achieved a correlation coefficient (r) of greater than 0.90 (0.990 and 0.988 respectively), indicating that the device met the implicit acceptance criterion for substantial correlation.

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

• Sample Size: 65 subjects for each palm alternate site (palm near thumb and palm near small finger), for a total of 130 samples specifically reported in the table. The phrase "With these data it is proved that the system accuracy with AST blood from calf, thigh and upper arm is unchanged from forearm" suggests additional data might have been collected for these sites, but the detailed statistics are only provided for the palm.
• Data Provenance: The study was "conducted at our manufacturing facility." This suggests it was an internal company study. There is no explicit mention of the country of origin for the data or whether it was retrospective or prospective. Given it's a study demonstrating consistent performance for a modified device, it is most likely a prospective study where samples were actively collected for the purpose of the study.

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

This information is not provided in the document. For a blood glucose meter, the "ground truth" or reference method is typically an established laboratory reference analyzer, not expert consensus. The document does not specify the reference method used.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth for a blood glucose meter is typically established by a laboratory reference method, not by human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This document describes a modification to a blood glucose meter, which is an in vitro diagnostic device. It does not involve human readers interpreting images or data, nor does it concern AI assistance.

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

• Yes, implicitly. The data presented are direct comparisons between the Accu-Chek Active System's readings from different sample sites. The performance metrics (slope, intercept, correlation) describe the device's accuracy without human intervention playing a role in interpreting the result displayed by the meter.

7. The Type of Ground Truth Used

The document does not explicitly state the specific reference method used to establish the "ground truth" or comparator for the finger results. However, for blood glucose meters, the standard ground truth is typically:

• A laboratory reference method (e.g., YSI analyzer, hexokinase method) run on a plasma sample, which is then mathematically converted to whole blood equivalent glucose values.
• Alternatively, the "finger results" from the Accu-Chek Active Meter itself could be considered the reference if the goal was solely to prove equivalence of AST to fingertip measurements with the same meter. The text "AST Sample versus Finger (Same Accu-Chek Active Meter)" suggests that the fingertip measurement from the same device served as the comparator for the AST readings.

8. The Sample Size for the Training Set

This information is not provided. The data presented is for the validation/test set. Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do. Development and calibration would involve internal studies, but those are distinct from the validation study described here.

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

• Not applicable / Information not provided. As mentioned above, a traditional "training set" with ground truth in the context of machine learning is not directly relevant here. For the internal development and calibration of the glucose meter, ground truth would have been established using highly accurate laboratory reference methods.

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The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, and calf

Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase

Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Active System (K021448):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for accuracy (e.g., % within a certain range). Instead, the study aims to demonstrate "good correlation (r > 0.90)" between results from different Alternative Site Testing (AST) locations and finger results.

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

The data is prospective as it was generated from a study specifically conducted to demonstrate the device's performance with additional AST sites.

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

This information is not provided in the given document. The study compares AST results to "finger results," which is implicitly considered the reference measure. It doesn't mention a separate expert review process for the glucose readings themselves.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Since the study compares the device's readings from different sites to readings from a fingerstick (likely the same device's reading from a fingerstick or a laboratory reference), a traditional adjudication method for subjective medical imaging interpretation wouldn't apply here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance, often in conjunction with AI. The provided study is a device performance study, not one evaluating human readers.

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

Yes, a standalone study was done. The study assesses the accuracy of the Accu-Chek Active System when using blood samples from various alternative sites. It evaluates the device's performance independently, without human interpretation as a primary factor in the measured outcome. The device itself is the "algorithm" in this context (photometric measurement).

7. The Type of Ground Truth Used

The ground truth used is fingerstick blood glucose readings. The study implicitly uses finger results (from the same device or a similar, validated method) as the reference standard to which the Alternative Site Test (AST) results are compared. The phrase "AST location versus Finger" directly indicates this comparison.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is a device performance study, not specifically an AI/machine learning model where a training set distinct from a test set would typically be described. The "study" mentioned likely refers to the overall validation of the modified device rather than the training of a computational algorithm.

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

Since there is no mention of a separate training set or an AI/machine learning model being developed, this information is not applicable/provided in the document. The device's underlying technology (photometry and glucose dehydrogenase chemical reaction) is well-established, and its "training" would have occurred during the initial development and validation of the predicate device (K012324), not detailed here.

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The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase

The provided text describes the Accu-Chek Active System and its substantial equivalence to a predicate device, focusing on features and intended use. However, it does not contain detailed information regarding the specific acceptance criteria, a comprehensive study report, sample sizes, expert qualifications, or ground truth establishment methods in the depth requested. The document is primarily a 510(k) summary and an FDA clearance letter.

Based on the available information, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All predetermined acceptance criteria were satisfied" but does not provide specific numerical acceptance criteria nor detailed reported device performance values. It only generally states that "The clinical data demonstrates that the performance of the Accu-Chek Active correlates well with the laboratory plasma glucose reference test method."

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: A "multi-center performance study" was conducted. The country of origin is not explicitly stated. It is a prospective study, as it was conducted to "evaluate the accuracy and precision of the modified device."

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

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in the provided text.

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

• MRMC Study: Not applicable. This device is a glucose meter, an automated system, not an AI-assisted diagnostic imaging or interpretation system requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
• Effect size of human reader improvement: Not applicable.

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

Yes, a "multi-center performance study" was conducted to evaluate the accuracy and precision of the device itself, which operates as an algorithm-only system without human-in-the-loop performance for glucose measurement. The device's performance was compared to "the laboratory plasma glucose reference test method."

7. The type of ground truth used

The ground truth was established by a "laboratory plasma glucose reference test method." This implies comparison to a validated and accurate laboratory-based glucose measurement method.

8. The sample size for the training set

Not specified in the provided text. (For this type of device, what might be referred to as "training" would be part of the R&D and calibration process, not distinct in the same way as an AI model's training set).

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

Not specified in the provided text. (As above, this information is not typically presented for a glucose meter in this format).

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