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The L-Dex U400: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women. This device is not intended to diagnose or predict lymphedema of an extremity.

Lymphedema Analysis PC Software – an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 analyzer/monitor for uploading data on to the PC from the L-Dex U400. processing and analyzing of bioimpedance measurements.

The L-Dex U400 is a multi frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance as with the XCA. These measurements and calculations are used to estimate extra cellular fluid (ECF) allowing for the assessment of the development of unilateral Lymphedema of the arms.

The ImpediMed L-Dex U400 Extra Cellular Fluid Analyzer, like the SFB7, is a battery powered, accurate, multi frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.

The provided text does not contain detailed information about specific acceptance criteria for the device or a study explicitly proving the device meets these criteria in the comprehensive manner requested. The document is primarily a 510(k) summary for the ImpediMed L-Dex U400, focusing on its intended use, device description, and technological characteristics, and stating its substantial equivalence to predicate devices.

However, based on the available information, here's what can be extracted and inferred:

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

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the L-Dex U400. It describes the device's function and its intended use, emphasizing its ability to accurately measure current, voltage, and phase angle, and calculate impedance, resistance, and reactance to estimate extracellular fluid (ECF) for the assessment of unilateral lymphedema.

The statement "The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance as with the XCA" and "The ImpediMed L-Dex U400, like the SFB7, is a battery powered, accurate, multi frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode" implies that its performance is considered comparable and accurate to its predicate devices.

Acceptance Criteria (Inferred from device description and intended use):

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

The provided document does not mention any specific test set sample size or data provenance details (e.g., country of origin, retrospective/prospective) related to a study for the L-Dex U400's performance validation. The 510(k) summary focuses on substantial equivalence to predicate devices rather than a de novo clinical study with a specific test set.

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 provided in the document.

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

This information is not provided in the document.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention AI assistance. This device is a bioelectrical impedance analyzer, not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

The device itself is a standalone instrument that measures bioelectrical impedance. The Lymphedema Analysis PC Software is an optional component for data upload, processing, and analysis. Its functionality is described as "algorithm only" in the sense that it converts measured impedance into an estimate of the L-Dex index based on "simple mathematics, bioelectrical and anthropometric parameters from peer reviewed published journal articles." The document does not explicitly present a "standalone performance study" in the context of an algorithm's diagnostic accuracy against a ground truth, but rather describes its operational capabilities and the basis of its calculations.

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

The document states that the device's estimates "can be used as alternatives to the current circumferential measurements and water immersion methods, to indicate trends toward the potential development of Lymphedema." This implies that the accepted "ground truth" or reference methods for assessing lymphedema, which the L-Dex aims to provide an alternative for, are circumferential measurements and water immersion. The underlying validation of the mathematical models used to convert impedance to the L-Dex index relies on "peer reviewed published journal articles."

8. The sample size for the training set

The document does not mention a "training set" in the context of a machine learning model. The device's calculations are based on established bioelectrical impedance principles and parameters derived from "peer reviewed published journal articles," which would imply an empirical basis rather than a data-driven training set for an AI model.

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

As there is no mention of a "training set" for an AI model, this information is not applicable. The basis for the device's calculations and interpretation (the L-Dex index) comes from scientific literature and established methods for studying extracellular fluid and lymphedema, which would have their own ground truth establishment methods (e.g., clinical diagnosis, volumetric measurements, expert assessment).

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(1) Imp XCA – A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.

(2) Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.

The Imp XCA is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for the clinical assessment of unilateral Lymphedema of the arm.

The provided document is a 510(k) Summary for the ImpediMed Imp XCA ExtraCellular Fluid Analysis device, which focuses on device description, intended use, and substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the requested information is not present in the provided text.

Here's what I can extract from the provided text:

• Device Name: ImpediMed Imp XCA ExtraCellular Fluid Analysis with Lymphoedema Analysis PC Software
• Intended Use: "A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity."

Without further documentation detailing clinical studies or performance testing with specific statistical endpoints, I cannot fulfill the request.

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(1) Imp SFB7 – A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole-Cole plot, resistance vs. frequency plot, reactance vs. frequency plot, subject height, age and sex.

(2) Biolmp Body Composition Analyzer PC Software: A PC software package that is intended to be used only with the ImpediMed Imp SFB7 Analyzer for uploading the MFBIA mode data on to the PC from Imp SFB7 via an Ethernet port for storing, processing and analysing of MFBIA bioimpedance measurements. This displays Cole-Cole plot, body composition parameters: Fatfree Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), Body Mass Index (BMI), and subject height, weight, age, sex, time, and date of measurement, Practitioner's name and Device serial number, and bioelectrical parameters resistance (R), reactance (Xc), and impedance (Z) and phase angle (Phi) at different frequencies (Between 4 kHz to 1000 kHz). The software can be used to generate patient body composition report displaying all the parameters stated above.

These devices are intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.

The Imp SFB7 is a multiple frequency bioelectrical impedance analyzer. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water (TBW), intracellular fluid (ICF), and extracellular fluid (ECF).

The device has 2 modes of operation

1. MFBIA Mode This is a Multiple Frequency Bioelectrical Impedance mode. Impedance readings are taken by applying all 256 frequencies sequentially in a very short time in the range of 4 kHz to 1000 kHz.

2. Selected Frequencies Mode - Any three user selected frequencies between 4 kHz to 1000 kHz and five pre set (5, 10, 50, 100, 500 kHz) frequencies are used to measure impedance of a subject.
   In MFBIA and Selected Frequencies mode, selection of single, continuous measurements or measurements at a selected interval of time is available. Over 1000 records can be stored and analyzed on Imp SFB7 or can be downloaded to a PC or laptop loaded with an optional Biolmp Body Composition Analysis software via an Ethernet connection.

The ImpediMed Imp SFB7 Body Composition Analyzer is a rechargeable battery powered, accurate, portable, multiple frequency bioelectrical impedance analysis instrument operating in tetra-polar (4 leads - 2 current source and 2 voltage sensing) mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.

Bioimpedance analyzers calculate complex impedance or opposition to the flow of an electric current by the body. The applied electrical current travels through the extra cellular fluid of the body and through the lean muscle-organs via the intracellular fluid. Impedance is low in lean tissue, extra cellular fluid and intracellular fluid, where electrolytes are primarily contained, but high in fat tissue because fat is primarily an insulator containing very few conducting elements. Therefore impedance can be related to the total water volume of the body because the impedance is a direct measure of both intracellular and extra cellular fluid. In the Imp SFB7 a small constant current, typically 200 uA RMS, with in the frequency range of 4 kHz to 1000 kHz sequentially, is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes is used to calculate the complex impedance value. The calibration of the device may be checked with the aid of the supplied test cell.

MFBIA Mode:
Imp SFB7 in MFBIA mode works by calculating the complex impedance, applying all 256 frequencies (4 kHz to 1000 kHz) sequentially in a very short time to reduce the time to complete the test and the inconvenience to the subject.

Impedance calculations made over a range of frequencies (4 kHz-1000 kHz) are used to create a Cole-Cole plot. Hanai modeling, which treats body as a concentrated suspension of cells in a conductive medium is used to estimate extracellular fluid (ECF) at low frequency and total body water (TBW) at high frequency. Intra cellular fluid (ICF) is then estimated by the difference between TBW and ECF. Fat free mass (FFM) is estimated from measured TBW assuming the hydration constant of a person as 73.2%. Fat mass (FM) is estimated from the difference between body mass and fat free mass.

Selected Frequencies Mode:
Imp SFB7 in Selected Frequencies mode has 5 pre set frequencies (5, 10, 50, 100, 500 kHz) and allows user to enter 3 frequencies of their choice in the range of 4 kHz to 1000 kHz to measure impedance of a subject. It measures, displays, and stores the impedance readings for these selected frequencies.

Here's an analysis of the acceptance criteria and study information for the ImpediMed Imp SFB7 Body Composition Analyzer, based on the provided text:

Based on the provided snippets, a formal acceptance criteria table with specific numerical thresholds and a detailed study proving those thresholds were met is not explicitly present. The documents primarily focus on regulatory submission, device description, and indications for use.

However, we can infer some information about the device's performance claims and the general approach to demonstrating its functionality.

Inferred Acceptance Criteria and Reported Device Performance

Since no specific "acceptance criteria" table or quantitative performance metrics (e.g., accuracy percentages, standard deviations) are provided in the current document, this table will reflect the general capabilities and intended functions described. The implied acceptance criterion is that the device accurately measures and calculates the stated body composition parameters.

Study Details (Limited information available in the provided text):

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

   • Sample size: Not specified in the provided documents.
   • Data provenance: Not specified. The company is Australian, so it's possible the data is from Australia, but this is not confirmed. It's also not stated if the data is retrospective or prospective.

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

   • Not specified. The document does not describe the specific study methodology that would involve experts establishing ground truth for a test set.

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

   • Not specified. This detail would only be relevant if a formal expert-based ground truth adjudication process was described.

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

   • Not mentioned. This device is a diagnostic tool for body composition, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. Therefore, an MRMC study in that context is unlikely for this type of device.

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

   • The provided document describes the device as performing direct measurements and calculations. The "Imp SFB7" is the standalone device that measures and calculates the body composition parameters. The "Biolmp Body Composition Analyzer PC Software" processes and analyzes the data from the standalone device. This implies a standalone computational performance of the device's algorithms. However, explicit performance metrics for this standalone performance (e.g., against a gold standard) are not detailed in these documents.

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

   • Not specified. Body composition analysis typically uses methods like DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing as a "gold standard" for ground truth. However, the document does not state which, if any, gold standard was used for validation.

7. The sample size for the training set:

   • Not specified. If the device uses predictive models (which BIA often does), a training set would be used. The document describes the methodology and calculations (e.g., Hanai modeling, 73.2% hydration constant) but does not detail how these models were derived or trained on a specific dataset.

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

   • Not specified. As noted above, the existence of a distinct "training set" with established ground truth is not detailed in these documents. The mention of "Hanai modeling" and assumed hydration constants suggests established physiological models are being applied, rather than machine learning on a specific, newly curated training dataset with its own ground truth establishment.

Summary of Missing Information and Context:

The provided documents are primarily a 510(k) summary and FDA clearance letter. These types of documents typically focus on demonstrating substantial equivalence to a predicate device and outlining the device's intended use and technological characteristics, rather than providing detailed clinical study protocols, acceptance criteria tables with performance statistics, or in-depth ground truth methodologies. For such details, one would usually refer to a more comprehensive clinical validation report or scientific publications.

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A body composition analyzer and a software package that will estimate display and store the following body composition parameters:

Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICVV), I Fut noo Mass (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). Extra octualiar vialer (2 x 77), voltage and phase angle (Phi), and from these values calculates The device moductions our only ready which are used to estimate the above body resistance (1), roustanto (1), roustanto (1), also display the user's height, weight, age, % oompoolion parameter of measurement, Practitioner's name and Device serial number.

This device is intended for use on healthy children (9 - 16 years old), general and obese adult rubjects, only for body composition assessment in the home or clinical environment.

The Imp DF50 is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water, intracellular water, and extracellular water.

The ImpediMed Imp DF50 Body Composition Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.

Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total body water volume. In practice, a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed frequency of 50 kHz± 100Hz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes.

Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration for lean tissue. Fat mass is subsequently calculated as the difference between body weight and lean body mass.

The provided text does not contain detailed information about specific acceptance criteria or a study proving that the ImpediMed Imp DF50 Body Composition Analysis device meets these criteria. The document is primarily a 510(k) summary for regulatory submission, focusing on device identification, intended use, technological characteristics, and substantial equivalence to predicate devices. It does not include performance data, study designs, sample sizes, or ground truth establishment relevant to acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document mentions that the device "accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance," and that "Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW." However, it does not detail the specific studies, their methodologies, or the performance metrics achieved against predefined acceptance criteria.

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