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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 irradiated.

The SOZO Pro is intended for adult patients living with heart failure.

This device is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).

The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:

• Fat mass

• Fat-free mass

• Total body water

• Intracellular fluid

• Extracellular fluid

• Skeletal muscle mass

• The following outputs are also presented:

• Body Mass Index (BMI)

• Basal metabolic rate (BMR; based on Mifflin St. Jeor's algorithm) displayed in calories per day

• Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.

The SOZO Pro device measures current (I), voltage (V) 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 plot, subject height, weight, age and sex.

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.

The provided text describes the SOZO Pro device, a bioimpedance spectroscopy device, and its 510(k) submission to the FDA. However, it does not contain the specific details about acceptance criteria, a comparative study with a human-in-the-loop, the exact sample sizes for test and training sets, the number and qualifications of experts for ground truth, or adjudication methods for all the stated indications for use.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device went through "appropriate testing per design controls to confirm functionality and performance of the indications." While specific numerical acceptance criteria (e.g., accuracy percentages, thresholds) are not explicitly provided in this document, the general categories of testing and the reported outcomes are:

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

• Test Set Sample Size: Not explicitly stated for any of the performance tests. The document mentions "fixed loads" for functional performance, implying a controlled, non-patient-specific test, and "a variety of pacemakers" for compatibility. For the software V&V, it states the software was "verified and validated," which implies testing, but sample size is not quantified.
• Data Provenance: Not explicitly stated. The document is a 510(k) summary for a device manufactured by ImpediMed Limited in Australia. The testing is likely conducted by the manufacturer, but the origin of the data used for performance comparison (e.g., patient data) is not specified. It does not indicate if it was retrospective or prospective.

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

• Not explicitly stated. The document focuses on technical performance and validation against engineering standards and a predicate device, rather than diagnostic accuracy studies involving expert human readers and a ground truth derived from clinical experts.

4. Adjudication Method for the Test Set

• Not applicable/Not explicitly stated. Since there's no mention of a human-in-the-loop diagnostic study or expert consensus for ground truth establishment, adjudication methods are not detailed.

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

• No, not explicitly stated or implied. The submission emphasizes substantial equivalence to a predicate device primarily through technical and functional comparisons, not through a comparative effectiveness study showing improvement in human reader performance with AI assistance. The document states, "The SOZO Pro is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data." This indicates it's an aid, not a standalone diagnostic that would typically undergo such a comparative study for its primary clearance.

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

• Yes, implied. The "Functional performance" section, where it states "performance testing was undertaken using fixed loads and comparing modified SOZO Pro to predicate SOZO measurements to demonstrate that outputs remained consistently accurate and precise," suggests standalone performance evaluation. The device measures impedance, resistance, reactance, and then calculates body composition parameters. The validation of these calculations against a known standard (fixed loads, predicate device performance) represents a standalone performance assessment.

7. The Type of Ground Truth Used

• Reference to Predicate Device and Engineering Standards: For most of the performance claims, the ground truth appears to be:

  • The performance of the predicate SOZO device (K203473).
  • Compliance with IEC 60601 (Electrical Safety/EMC), ISO 62304 (Software V&V), ISO 10993 (Biocompatibility), NIST Handbook 44 and EU Directive 2014/31/EU (Weight Scale).
  • Fixed loads for functional performance testing.
  • ISO 14117 for pacemaker/ICD compatibility.

  There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth for the device's diagnostic or monitoring capabilities beyond aiding clinical assessment.

8. The Sample Size for the Training Set

• Not applicable/Not stated. This device does not appear to be an AI/ML device that requires a distinct "training set" in the conventional sense for a deep learning model. It's a bioimpedance spectroscopy device that measures physical parameters and applies algorithms (e.g., Mifflin St. Jeor for BMR). The "software updates were included to integrate the scale and weight measurement capabilities," but this doesn't imply a self-learning algorithm that would require a training dataset.

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

• Not applicable. As it does not appear to be an AI/ML device with a training set, this information is not relevant or provided. The algorithms it uses (e.g., for body composition) are likely fixed formulas validated against general physiological principles and existing scientific literature.

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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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The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).

The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:

• · Fat mass
• · Fat-free mass
• Total body water
• · Intracellular fluid
• · Extracellular fluid
• Skeletal muscle mass

The following outputs are also presented:

• · Body Mass Index (BMI)
• · Basal metabolic rate (BMR; based on Mifflin St. Jeor's algorithm) displayed in calories per day

• Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.

The SOZO Pro device measures current (1), voltage (V) 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 plot, subject height, weight, age and sex.

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.

The provided text is a 510(k) summary for the ImpediMed SOZO Pro device. It describes the device, its indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of AI-driven performance or human reader improvement.

The "Performance Data" section primarily focuses on:

• Electrical safety/EMC: Tested according to IEC 60601 standards.
• Software V&V: Tested according to ISO 62304.
• Biocompatibility: Tested according to ISO 10993.
• Functional performance testing: "undertaken using fixed loads and comparing modified SOZO Pro to predicate SOZO measurements to demonstrate that outputs remained consistently accurate and precise." This is high-level and lacks specifics on metrics or thresholds.
• Weight Scale Verification: Performed according to NIST Handbook 44 and EU Directive 2014/31/EU.

Since the provided document does not include the specific details you've requested regarding acceptance criteria and performance study for, for example, an AI component's diagnostic accuracy, human-in-the-loop performance, or detailed ground truth establishment, I cannot populate all sections of your request.

Based on the available information, here is what can be inferred and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not specified. The document mentions "fixed loads" for functional testing and a comparison to the predicate device, but no human subject test set size for evaluating body composition parameters is detailed.
• Data Provenance: Not specified. It's likely the testing occurred during device development/modification.

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

• Not applicable/Not specified. The testing described focuses on engineering/functional validation (electrical, software, biocompatibility, scale accuracy, and comparison to predicate measurements using fixed loads), not on establishing diagnostic ground truth from human data for body composition parameters. The device provides "estimates" and tracks parameters over time, suggesting its performance is validated against its own internal consistency or engineering standards rather than external "expert" ground truth for individual body composition values in a clinical diagnostic sense based on this document.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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

• Not applicable. This device is a Bioimpedance Spectroscopy (BIS) device for body composition analysis, not an AI-assisted diagnostic imaging device requiring human reader interpretation or MRMC studies. The document does not describe any AI component that would require human-in-the-loop evaluation for diagnostic improvement.

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

• The "Performance Data" section discusses "functional performance testing" using "fixed loads" and comparison to the predicate device, which would be a form of standalone performance evaluation for the device's measurement capabilities.
• The software V&V confirms the software meets acceptance criteria and performs as intended.
• However, specific standalone accuracy metrics (e.g., against a gold standard for body composition in human subjects) are not provided in this summary.

7. The type of ground truth used:

• For electrical, software, biocompatibility, and scale testing: Engineering standards, established regulatory requirements, and fixed measurement loads act as "ground truth."
• For "functional performance testing" of body composition outputs: The "ground truth" used was a comparison to the predicate SOZO measurements and "fixed loads" to ensure "consistently accurate and precise" outputs. There is no mention of a clinical gold standard (e.g., DEXA, whole-body MRI, dilution methods) used as ground truth for the body composition parameters in human subjects for this specific K-summary documentation.

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a medical device, not an AI model that undergoes "training" in the machine learning sense with a distinct training dataset. The device measures bioimpedance and calculates parameters using established physiological models and algorithms.

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

• Not applicable. As above, this is not an AI model that undergoes training on a dataset with external ground truth. The device relies on biophysical principles and algorithms for its calculations.

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