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The SOZO Pro has the following uses:

For adult human patients at risk of lymphedema:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.

The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or imadiated.

The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered.

Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.

This FDA 510(k) summary doesn't provide detailed information on specific acceptance criteria and a comprehensive study designed to prove the device meets those criteria in terms of clinical performance. Instead, it focuses on verifying the modifications to an existing predicate device (SOZO) by showing that the new device (SOZO Pro) still performs comparably and meets regulatory standards for safety and fundamental performance.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of clinical performance acceptance criteria and reported results. The "Performance Data" section primarily addresses engineering and regulatory compliance rather than direct clinical efficacy for its intended use (aid in clinical assessment of lymphedema).

The closest indications of acceptance criteria and performance relate to engineering and regulatory standards:

Missing Information (and likely not present in a 510(k) Special submission for this type of modification):

The 510(k) Special is for modifying an existing cleared device. Therefore, a new, comprehensive clinical study demonstrating the clinical effectiveness of the L-Dex ratio itself (which was established for the predicate device) is usually not required. The focus is on showing the modifications do not negatively impact the established performance.

1. Sample size used for the test set and the data provenance: Not explicitly stated for clinical performance as clinical effectiveness was likely established with the predicate device. For functional performance, "fixed loads" were used, implying a lab-based test, not a patient test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this 510(k) does not describe a clinical ground truth establishment study.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device provides a quantitative L-Dex ratio, not an image for interpretation by multiple readers.
5. Standalone (algorithm-only) performance: The device is a standalone algorithm that provides an L-Dex score. Its performance in generating this score consistently is implied by the functional testing ("outputs remained consistently accurate and precise").
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the clinical use of the L-Dex ratio as an aid in lymphedema assessment, this ground truth would have been established with the predicate device and is not detailed here. The current submission focuses on engineering verification.
7. Sample size for the training set: Not applicable. This device uses a bioimpedance spectroscopy algorithm to derive an L-Dex ratio, not a machine learning model that typically requires a clinical training set in the sense of AI/deep learning. The "algorithm" here is physics-based.
8. How the ground truth for the training set was established: Not applicable for the reasons above.

In summary: The provided 510(k) summary focuses on demonstrating that the modifications to the SOZO Pro (weight scale, hardware, software integration) do not compromise the established safety and performance of the original SOZO device. It confirms compliance with various engineering and regulatory standards but does not re-evaluate the clinical efficacy of "L-Dex ratio as an aid to clinical assessment of lymphedema" through a new clinical trial, as that was likely part of the original predicate device's clearance.

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MoistureMeterD Compact and LymphScanner is a device utilizing inter-am ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected ann tissues to aid in forming a clinical judgment of unilateral lymphedema in adult women. The device is not intended to make a dagnosis or predict arm lymphedema.

The MoistureMeterD Compact (MMDC) and the LymphScanner are identical differently labelled bioelectrical analyzers to measure localized tissue fluid content. High-frequency electromagnetic waves produced in the hand-held main unit are guided into integrated open-ended coaxial probe. When the probe is placed onto the skin, skin and upper subcutis is exposed to electromagnetic field. In skin and upper subcutis electromagnetic fields are interacting with tissue water molecules by rotation causing absorption of electromagnetic energy in tissue. The devices measure the amplitude and phase shift of the reflected electromagnetic wave and calculate tissue dielectric constant (TDC). Tissue dielectric constant (TDC) is an index of localized tissue water content. The measured TDC value can be converted into Percentage Water Content (PWC) value.

The provided text describes the Delfin Technologies Ltd. MoistureMeterD Compact and LymphScanner devices and their substantial equivalence to a predicate device (MoistureMeterD). It discusses the indications for use, technology, and clinical studies used to demonstrate substantial equivalence, but it does not explicitly provide a table of acceptance criteria and reported device performance with specific values.

However, based on the information provided, I can infer the type of study conducted and the general nature of the acceptance criteria.

Inferred Acceptance Criteria and Reported Device Performance (General):

Study Details based on the provided text:

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

   • Sample Size: The text states clinical studies were conducted in "healthy female volunteers, women waiting for surgery of breast cancer, women operated for breast cancer, women at risk for lymphedema or a diagnosis of lymphedema." It does not specify the exact number of participants in these studies for the test set.
   • Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The studies are referred to as "clinical studies," implying prospective data collection relevant to the device's application.
   • Retrospective or Prospective: Implied to be prospective ("clinical studies in healthy female volunteers, women waiting for surgery..."), where data was likely collected specifically for the purpose of demonstrating equivalence.

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

   • The document does not provide information on "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images). The device itself measures tissue dielectric constant (TDC)/Percentage Water Content (PWC), which is a direct physiological measurement. The "ground truth" implicitly relates to the physiological state of lymphedema, which is then assessed by comparing the device's readings.
   • The text mentions the device "supports local assessment of tissue water differences... to aid in forming a clinical judgment," but it doesn't detail how that clinical judgment (ground truth for lymphedema diagnosis) was established in the study, nor the qualifications of clinicians making these judgments within the context of the study.

3. Adjudication method for the test set:

   • The document does not describe any adjudication method. This is likely because the study focuses on the instrumental equivalence of measurements (TDC/PWC ratios) rather than a diagnostic performance evaluation where multiple human readers might disagree.

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, an MRMC comparative effectiveness study was not done. The device (MoistureMeterD Compact/LymphScanner) is a measurement tool, not an AI-assisted diagnostic algorithm intended to improve human reader performance in interpreting complex data (like medical images). The study focused on the equivalence of the device's measurements to a predicate device.

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

   • This is not applicable in the typical sense of AI algorithms. The device itself is a standalone measurement instrument. The study essentially compared the standalone performance of the new devices (MoistureMeterD Compact/LymphScanner) to the standalone performance of the predicate device (MoistureMeterD) in generating TDC/PWC ratios. The "algorithm" here is the embedded software that calculates TDC/PWC from raw electromagnetic wave data. The core finding was that these algorithmic outputs were not statistically different between the new and predicate devices.

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

   • The "ground truth" in this context is implicitly the actual physiological tissue water content and its differences between arms, as measured by the predicate device. The study aims to show that the new devices produce measurements that are equivalent to this established "truth" (i.e., the predicate device's measurements).
   • The clinical judgment of unilateral lymphedema, which the device aids in forming, would be an outcome, but the study focuses on the equivalence of the measurement values themselves (TDC/PWC ratios) to the predicate device.

7. The sample size for the training set:

   • The document does not specify a separate "training set" sample size. The study described is for validation/equivalence of the measurement itself, not for training a machine learning model in the conventional sense. The device's underlying physics-based calculations are already established.

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

   • As there's no explicitly mentioned "training set" for an AI model, this question is not applicable in the context of the provided text. The device's functionality is based on established physical principles of electromagnetic wave interaction with tissue water, rather than being "trained" on a dataset to learn patterns.

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For adult human patients at risk of lymphedema:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.

The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.

The SOZO system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("SOZOhub") contained within the hospital/facility network.

Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO™ system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced logarithmically from 3kHz to 1000kHz and measures the resulting voltage levels. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review. This score facilitates their clinical assessment of lymphedema in adult human patients.

The SOZO® device is a bioimpedance spectroscopy device intended for adult human patients at risk of lymphedema. It uses impedance ratios to display an L-Dex ratio, aiding clinicians in assessing lymphedema by measuring extracellular volume differences between limbs.

Here's an overview of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific sample size for the "clinical testing" mentioned, nor does it detail the provenance (country of origin, retrospective or prospective) of the data used for establishing the strong correlation of extracellular fluid levels. For the "comparative performance vs. predicate device" test, the "test set" consisted of a test fixture creating "multiple fixed impedance loads representing different 'humans'".

3. Number of Experts and Qualifications:

The document does not specify the number or qualifications of experts used to establish ground truth for any of the tests. For "clinical testing," it refers to "studies" that identified the applicability of the BIS technology, implying clinical expertise was involved in those studies, but no details are provided here.

4. Adjudication Method:

The document does not mention any adjudication method for establishing ground truth within the context of the provided performance data.

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

The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is presented as an "aid to their clinical assessment," suggesting a human-in-the-loop scenario, but no comparative effectiveness study of this nature is detailed.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was conducted for the device. The comparative performance against the predicate device using a test fixture and the "clinical testing" demonstrating correlation of extracellular fluid levels support the algorithm's standalone performance in producing the L-Dex ratio.

7. Type of Ground Truth Used:

• For Electrical Safety/EMC, Software V&V, Biocompatibility, and Functional Performance, the ground truth was based on adherence to international standards and internal design specifications/requirements.
• For Clinical Performance, the ground truth seems to be implicitly derived from established clinical understanding of lymphedema and extracellular fluid levels, as evidenced by "studies (that) have identified the applicability of ImpediMed's BIS technology." While not explicitly stated as "expert consensus," the nature of clinical assessment of lymphedema often relies on expert judgment integrated with objective measures.
• For Comparative Performance vs. Predicate Device, the ground truth was established by comparing the SOZO system's outputs against the outputs of already established predicate devices (ImpediMed U400 and SFB7) when presented with the same "fixed impedance loads." This implies the predicate devices' outputs served as the reference or "ground truth" for correlation.

8. Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its sample size. The "Established algorithms are used to analyze data" implies algorithms were developed and likely trained, but details about the training process are not provided in this summary.

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

This information is not provided in the document.

Ask a specific question about this device

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated.

SOZOhub PC software - a PC software package that is intended to be used only with the ImpediMed SOZO device for uploading data on to the PC from the SOZO device, processing and analyzing of bioimpedance measurements.

The SOZO system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("SOZOhub") contained within the hospital/facility network.

Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO system measures small quantities of electrical energy (200ua RMS) across 256 frequencies, spaced logarithmically from 3kHz to 1000kHz. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review. This score facilitates their clinical assessment of unilateral lymphedema of the arm and leg in woman, and the leg in men.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets those criteria, formatted to address your specific points.

First, it's important to note that the provided documentation is a 510(k) premarket notification letter and summary for the SOZO™ device, which is an Impedance Plethysmograph (specifically, a bioimpedance spectroscopy device for assessing lymphedema). This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria and effect sizes as might be required for a PMA (Premarket Approval). Therefore, some of your requested information (e.g., effect size of human readers improving with AI, specific acceptance criteria for a clinical outcome, detailed ground truth establishment for a large test set) may not be present or applicable in this context.

The document emphasizes design changes to an existing technology (the L-Dex® U400) and the SOZO system's equivalence to that predicate. The "performance data" section primarily covers engineering and non-clinical testing.

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for clinical performance in the sense of a clinical trial. Instead, the performance data focuses on demonstrating that the new design of the SOZO system functions reliably and maintains characteristics similar to its predicate device. The "acceptance criteria" are implied by the successful completion of various engineering and non-clinical tests.

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

The provided text does not specify a sample size for a clinical "test set" involving human subjects for performance evaluation. The "comparative performance vs. predicate device" was conducted using a "test fixture to create multiple fixed impedance loads representing different 'humans'." This is a laboratory-based, non-clinical test.

• Sample Size for Test Set: Not applicable for a human clinical test set. The comparative test used a "test fixture" with "multiple fixed impedance loads."
• Data Provenance: The testing appears to be primarily laboratory-based, likely conducted by the manufacturer (ImpediMed Limited, Australia) or accredited third-party labs. It is not described as involving retrospective or prospective human clinical data.

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

This information is not applicable as the "test set" was not a human clinical dataset requiring expert interpretation. The ground truth for the device's measurements is based on the physical properties of the "fixed impedance loads" used in the test fixture.

4. Adjudication Method for the Test Set

Not applicable, as there was no human-interpreted test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The device (SOZO) provides an L-Dex ratio, which is then used by a clinician as an "aid to their clinical assessment." This submission demonstrates the fidelity of the SOZO device's measurements compared to its predicate, not the impact on human reader performance. Therefore, there's no mention of an effect size for human readers improving with AI vs. without AI assistance because this is not an AI-based diagnostic tool in the sense that it provides an assessment directly to the clinician that then gets compared to human performance. It is a measurement device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device's core functionality is its standalone measurement capability. The "L-Dex ratio" is a direct output of the device's algorithms based on bioimpedance spectroscopy data. The comparative test against the predicate device using a test fixture effectively evaluates this "standalone" measurement performance in a controlled environment. The "very strong correlation (r > 0.99)" reported indicates its standalone performance similarity to the predicate.

7. The Type of Ground Truth Used

The "ground truth" for the comparative performance study was the known, "fixed impedance loads" created by the test fixture. This serves as a known standard against which the measurements of both the SOZO device and the predicate U400 system were compared.

8. The Sample Size for the Training Set

The document does not specify a sample size for a "training set." This is likely because the device is based on "established algorithms" (Section 3: Device Description) and bioimpedance spectroscopy principles, rather than a machine learning model that would typically require a distinct training dataset to learn patterns. The focus is on the hardware and software's ability to accurately apply these existing algorithms and measure bioimpedance correctly.

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

As there's no mention of a traditional "training set" for a machine learning model, the concept of establishing ground truth for it is not applicable in this document. The device relies on established scientific principles and algorithms for bioimpedance analysis, which were presumably developed and validated over time, but not detailed as a "training set" here.

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Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.

The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.

I apologize, but the provided text does not contain the specific details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, or adjudication methods for the Delfin MoistureMeterD. The document is an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to a predicate device but does not include the detailed study results that would typically contain such information.

To answer your request thoroughly, I would need a different document, such as a clinical study report, a scientific publication, or a more detailed section of the 510(k) submission that discusses the performance testing.

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A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated.

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

The ImpediMed L-Dex U400 Extra Cellular Fluid Analysis device is a battery powered bioimpedance spectroscopy device operating in tetra-polar mode via a set of leads that are attached to self-adhesive skin electrodes by means of alligator clips. The subject device accurately measures current, voltage and phase angle, and cakulates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc). These measurements and calculations are used to estimate extracellular fluid ratios, and calculate the Lymphedema Index or L-Dex.

The L-Dex U400 measures bioimpedance parameters over a frequency range of 4 - 1000 kHz with 256 data points. An on-screen graph displays the raw measured data in the form of a resistance vs. reactance complex impedance plot. These bioelectrical parameters are then used in algorithms to give an L-Dex value for the affected compared to the unaffected limb.

Measured impedance ratios (L-Dex values) and normal ranges are shown on the device immediately after measurement and stored for later reference. Measured data may be transferred to the ImpediMed Impsoft database software. The Impsoft software adds extra functionality and ease of data management, including viewing patient histories and printing reports.

Here's an analysis of the provided text regarding the ImpediMed L-Dex U400 and its performance claim, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission is a 510(k) for substantial equivalence to a predicate device (K100811), not a de novo clearance with defined performance acceptance criteria. The "Performance Data" section explicitly states: "The company has provided an overview of reports in the literature that describes the use of the device for its indications for use." This indicates that the submission relies on existing literature and comparison to its own previously cleared device, rather than new, primary performance studies with explicit acceptance criteria for the current submission.

Therefore, since no specific acceptance criteria for this 510(k) submission are mentioned, and the performance data refers to an "overview of reports in the literature," a table of acceptance criteria and reported performance cannot be generated from the given text. The FDA's substantial equivalence decision is based on the new device being "as safe and effective" as the predicate.

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

The document does not detail any specific de novo test set for this 510(k) submission. It states: "Performance data demonstrate that the subject device is as safe and effective as the company's predicate device for the proposed indications for use." This implies reliance on data from the predicate device's clearance (K100811) or general literature, but no sample size or data provenance (country, retrospective/prospective) for a new test set is provided in this document.

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

Since no de novo test set or specific performance study is detailed for this 510(k) in the provided text, there is no information on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

As no de novo test set or specific performance study is detailed, no adjudication method is mentioned in the provided text.

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

The document does not mention any MRMC comparative effectiveness study being performed for this 510(k) submission, nor does it discuss the effect size of human readers with or without AI assistance. The device is a bioimpedance spectroscopy device, not an image-reading AI.

6. Standalone (Algorithm Only) Performance Study

The information provided suggests that the device's function is to measure bioelectrical parameters and calculate an L-Dex value, which is then "presented to the clinician on an L-Dex scale as an aid to their clinical assessment." This implies human-in-the-loop use. However, the document does not detail a standalone performance study in the context of this 510(k) submission. The performance claim is for substantial equivalence to its predicate.

7. Type of Ground Truth Used

The document focuses on substantial equivalence based on technological characteristics and intended use. It does not describe the type of ground truth (e.g., pathology, outcomes data, expert consensus) used for any specific performance study related to this 510(k) submission. Any "ground truth" would likely refer to the data used in the "reports in the literature" that describe the use of the device.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a 510(k) submission for a device, not a new AI algorithm development requiring a distinct training phase to develop the L-Dex algorithm itself. The algorithms are already established in the predicate device.

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

Since no training set is mentioned in the context of this 510(k) submission, there is no information on how its ground truth was established. The L-Dex algorithm itself would have been developed and validated previously, and those details are not part of this specific 510(k) summary.

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A bioclectrical impedance analyzer/monitor for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extra cellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated.

The device is not intended to diagnose or predict lymphedema of the 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 ExtraCellular Fluid Analyzer like its predicate is a multi-frequency bioelectrical impedance analyzer. It is a non-invasive, battery powered extracellular fluid status analyzer.

The L-Dex® U400 accurately measures current, voltage and phase angle, calculates impedance, resistance and reactance as with its predicate. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for aiding in the assessment of the development of unilateral Lymphedema of the limbs.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. The submission is a 510(k) premarket notification primarily focused on demonstrating substantial equivalence to a predicate device for expanded indications for use.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or a direct performance table for the L-Dex® U400 ExtraCellular Fluid Analyzer. Instead, it relies on demonstrating that the device is substantially equivalent to its predicate (L-Dex® U400 ExtraCellular Fluid Analyzer, K080825) in terms of design, construction, hardware, software, operational features, and safety features.

The core performance claim is its ability to "accurately measure current, voltage and phase angle, calculate impedance, resistance and reactance" and use these to "estimate extracellular fluid (ECF) allowing for aiding in the assessment of the development of unilateral Lymphedema of the limbs." However, specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, or inter-rater reliability values) are not provided in this summary.

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

The document states, "Clinical Performance data in support of the expanded indications for use is included within this submission." However, it does not provide any details about:

• The sample size used for any clinical test set.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
• The type of study design for this clinical performance data.

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

The document does not mention using experts to establish ground truth for a test set. This type of detail would typically be found in a more comprehensive clinical study report, which is not included in this 510(k) summary.

4. Adjudication Method for the Test Set:

Since there is no mention of experts or a test set requiring adjudication, there is no information on the adjudication method.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with AI assistance. The device is described as "a bioelectrical impedance analyzer/monitor," which suggests a direct measurement device rather than an AI-assisted diagnostic tool for human readers.

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

The document focuses on the device's ability to measure and calculate, with the output (L-Dex ratio) being presented to a clinician "as an aid to their clinical assessment." This implies a standalone performance of the device's measurements and calculations. However, no specific standalone performance metrics (like accuracy against a gold standard for ECF volume differences) are provided in this summary. The "clinical performance data" mentioned must have related to this, but the details are omitted.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any clinical performance data. Given the device's function to aid in the assessment of lymphedema, potential ground truths could include:

• Physical measurements (e.g., circumference measurements)
• Diagnosis by a specialist physician (e.g., lymphedema specialist)
• Imaging techniques
• Pathology (though less likely for lymphedema diagnosis in this context)
• Outcomes data

However, none of these are confirmed in the provided text.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This information would typically be relevant for machine learning algorithms, and while the device uses "bioelectrical impedance analyzer/monitor" it is not explicitly stated to be an AI/ML device in the modern sense. It calculates impedance ratios, which implies a pre-defined algorithm rather than one that learns from a training set.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

In summary:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for expanded indications, rather than providing detailed acceptance criteria and supporting clinical study results with specific metrics, sample sizes, and ground truth methodologies. The core argument for safety and effectiveness relies on the L-Dex® U400 being identical in design and function to a previously cleared device. Information regarding specific clinical performance data is noted as being included in the full submission, but not detailed in this summary.

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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.

Ask a specific question about this device