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The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The Normatec Elite is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery.

The user interface on the Normatec Elite is a series of buttons with a small display the treatment time, pressure level, zone boost number. The user interface provides for:

• Starting and stopping the massage treatment; .
• . Adjusting time and intensity (pressure) of the treatment;
• Selection of the zone to boost the pressure .

In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

This document is a 510(k) Premarket Notification from the FDA for a medical device called Normatec Elite. The document details the device's characteristics and compares it to a predicate device (Normatec 3). However, it does not contain the specific acceptance criteria or the full study details to prove the device meets these criteria in the way you've requested.

The document states:

• "Performance testing demonstrated that the proposed device met its acceptance criteria." (Page 11)
• "Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria." (Page 11)

Despite these statements, the document does not explicitly list the quantitative acceptance criteria for performance (e.g., specific pressure ranges, circulation increase percentages, muscle ache relief metrics) nor does it provide a detailed study that proves these criteria were met. It mentions "Testing of all controls," "Testing of all indicators," "Testing of battery state indicators," "Testing of performance," and "Testing of hazard mitigations" as types of bench testing performed, but no specific results or methodologies are shared.

Therefore, for your request, I can only provide the information that is present in the document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided: The document states that performance testing met acceptance criteria, but it does not list the specific quantitative acceptance criteria or the reported device performance details (e.g., what specific values were achieved for pressure, time, etc., against defined thresholds). It only broadly mentions general areas of testing.

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

• Cannot be provided: The document mentions "Performance testing" and "Bench testing" but does not specify any sample sizes for a test set or the provenance of any data used for testing (e.g., patient data, country of origin, retrospective or prospective). This device is a massager, and the testing described appears to be bench testing for device functionality rather than clinical studies on human subjects with specific sample sizes.

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)

• Cannot be provided: This information is not present. The document focuses on the engineering and regulatory comparison of the device to a predicate, not on a study involving human experts establishing ground truth for a diagnostic or interpretive task.

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

• Cannot be provided: This information is not present 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

• Cannot be provided: This information is not present. The device is a powered inflatable tube massager, not a diagnostic imaging device typically requiring MRMC studies. There is no mention of AI assistance in relation to human readers.

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

• Cannot be provided: While the device uses a "Microprocessor" and "Bluetooth communication ability" to control inflation sequences, the document does not describe "standalone algorithm performance" in the context of diagnostic AI or a human-in-the-loop comparison. The "performance testing" mentioned is for the device's operational functionality (controls, indicators, battery, hazard mitigations).

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

• Cannot be provided: The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable to the descriptions of testing in this document. The testing described is functional verification against pre-defined engineering and safety specifications, not "ground truth" derived from clinical outcomes or expert labels.

8. The sample size for the training set

• Cannot be provided: The document does not describe any machine learning/AI models that would require a "training set" in the conventional sense. The "Microprocessor Control" mentioned refers to the device's embedded firmware, not a trainable AI model with a distinct training set.

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

• Cannot be provided: As no training set is described, this information is not applicable.

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The Normatec Go is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

The Normatec Go is a powered, inflatable tube, calf massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device is to be used by people who are in good health. The device is charged from an external compliant power supply and powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Normatec Go is a series of buttons with one small display screen, to display the treatment time. located on the control unit mounted on the calf wrap. The user interface provides for:

• . Starting and stopping the massage treatment;
• . Adjusting time and intensity (pressure) of the treatment;
  In addition to the user interface on the proposed device, the device also has Bluetooth capability that allows the use of the NormaTec app to control the device. The Normatec app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience

The provided text describes a 510(k) summary for the Normatec Go device, which is an air pressure massager. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in the typical format of a performance study report.

However, based on the information provided, we can infer the acceptance criteria and the types of studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table of quantitative acceptance criteria with numerical performance targets and reported values. Instead, it discusses "equivalent specifications of performance" and "met all acceptance criteria" when comparing to predicate devices. The primary performance characteristic highlighted with a numerical difference is the maximum pressure.

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

The document does not provide details on the sample size for any specific test sets (e.g., number of devices tested, number of measurements). It only states that "Testing performed demonstrated that the proposed device meets defined requirements and performance claims."

The data provenance is not explicitly stated. The studies are described as "Performance Testing," "Verification and Validation activities," and "nonclinical tests," which are typically conducted in-house by the manufacturer (NormaTec Industries, LP) during product development and regulatory submission. No information about country of origin of data or retrospective/prospective nature is provided.

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

This section is not applicable as the document does not describe studies that require expert-established ground truth in the context of medical image interpretation or similar diagnostic applications. The testing described is primarily engineering and product performance verification.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. There is no mention of human-reviewed test data requiring adjudication.

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 section is not applicable. The Normatec Go is an air pressure massager, not an AI-powered diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its regulatory submission as described.

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

This is not applicable as the device is not an algorithm, but a physical massager with integrated software/firmware for control. The software V&V (Verification and Validation) was part of the performance testing, evaluating the algorithm's functionality within the device.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, expert consensus) is not applicable to the performance testing described for this device. The "ground truth" for the engineering performance tests would be established by objective measurements against predefined specifications (e.g., a pressure gauge to measure output pressure, a timer to measure treatment duration, electrical tests for battery performance).

8. The Sample Size for the Training Set

This section is not applicable as this device does not utilize a "training set" in the context of machine learning or AI algorithm development. The device's software is likely based on deterministic control logic, not trained models.

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

This section is not applicable for the same reason as #8.

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The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

The Normatec 3 is a powered inflatable tube massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-2 compliant lithium-ion battery.

The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for:

• Starting and stopping the massage treatment; .
• Adjusting time and intensity (pressure) of the treatment; .
• Selection of Attachment in use (Leg, Arm, Hip); .
• . Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected

In addition to the user interface on the devices the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

This document is a 510(k) Premarket Notification from the FDA for a medical device called Normatec 3. It compares the Normatec 3 to a predicate device (NormaTec Pulse 2.0 and Pulse Pro 2.0, K183169) to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported device performance values. Instead, it asserts substantial equivalence based on a comparison of characteristics between the proposed device (Normatec 3) and the predicate device (NormaTec Pulse 2.0 / Pulse Pro 2.0).

The "acceptance criteria" are implicitly met by demonstrating that the Normatec 3 is substantially equivalent to the predicate device across various aspects. The "reported device performance" is essentially the demonstrated equivalence to the predicate's performance and compliance with relevant standards.

Here's a summary derived from the provided text:

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

The document does not specify a numerical sample size for a test set that would typically be used in a clinical study to evaluate device performance against specific clinical acceptance criteria.

The evaluation for the Normatec 3's substantial equivalence appears to rely primarily on non-clinical testing to demonstrate compliance with standards and equivalence to the predicate device. The text states:

• "Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed."
• "Testing performed demonstrated that the proposed device meets defined requirements and performance claims."
• "The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as the predicate device..."

This suggests engineering and bench testing rather than human subject testing to generate a "test set" in the context of clinical performance data. Therefore, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here as a distinct clinical test set is not described.

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

This information is not applicable/not provided. The assessment for the Normatec 3 is based on engineering and performance comparisons, and compliance with standards, rather than expert-adjudicated clinical data to establish a "ground truth."

4. Adjudication method for the test set

This information is not applicable/not provided for the same reasons as point #3. There is no mention of a human-reviewed "test set" requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers interpret medical images or data. The Normatec 3 is a physical therapy device (powered inflatable tube massager) and does not involve human readers interpreting medical cases. Furthermore, it is not an AI-assisted device in the context typically seen in MRMC studies.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy is not applicable and was not done. The Normatec 3 is a physical device, and while it has software/firmware and Bluetooth control, its core function is physical massage, not algorithmic diagnosis or interpretation. The "algorithm" here controls the physical inflation/deflation cycle.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology for cancer detection, expert consensus on imaging findings) is not directly applicable in this submission.

Instead, the "ground truth" for the device's performance is implicitly established by:

• Compliance with recognized voluntary standards (e.g., IEC 60601 series for electrical medical equipment safety).
• Engineering specifications and measurements demonstrating the device performs within expected physical parameters (e.g., pressure range, cycle type).
• Equivalence to the legally marketed predicate device, implying that if the predicate is safe and effective, and the new device is substantially equivalent, then it also meets safety and effectiveness criteria.

8. The sample size for the training set

This information is not applicable/not provided. The Normatec 3 is a physical device with embedded software; it is not primarily an AI/machine learning model that undergoes "training" on a dataset in the typical sense. Its control logic is programmed, not learned via large data sets.

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

This information is not applicable/not provided for the same reasons as point #8. There is no mention of a traditional "training set" or "ground truth" establishment for training in this 510(k) submission.

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The NormaTec Pulse 2.0 and Pulse Pro 2.0 are air pressure massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec Pulse 2.0 and Pulse Pro 2.0 are powered inflatable tube massagers (Product Code "IRP"). They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by the use of an inflatable pressure ouff. The devices are to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.

The user interface on the Pulse Pro 2.0 model is 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). The user interface on the Pulse 2.0 model is 4.3" color LCD screen with smart switches. There is no difference in function between the two interface technologies, they are offered for marketing differentiation and user preferences. The user interface provides for:

• . Starting and stopping the massage treatment;
• . Adjusting time and intensity (pressure) of the treatment.

In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the Bluetooth app mimics the device interface graphics and buttons. allowing the user to use a compatible Android or iOS phone to control device functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide or unlock any additional features or alter the therapy provided by the device.

The provided text describes a 510(k) premarket notification for the NormaTec Pulse 2.0 and Pulse Pro 2.0 devices. This type of submission establishes substantial equivalence to a predicate device, rather than performing a de novo study against defined acceptance criteria and performance metrics. Therefore, many of the typical study design questions (like sample size, ground truth, expert adjudication, etc.) are not applicable in the same way they would be for a direct performance study.

Instead, the submission focuses on demonstrating that the new devices are as safe and effective as the predicate device (NormaTec Pulse and Pulse Pro, K160608).

Here's a breakdown of the information that can be extracted, and where the requested information is not explicitly provided due to the nature of a 510(k) submission:

1. Table of acceptance criteria and reported device performance:

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific acceptance criteria in the traditional sense of a new device performance study with quantitative metrics (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance criteria" here largely revolves around demonstrating equivalence to the predicate device in various aspects.

The table below summarizes the comparison presented in the document, effectively serving as the "performance" of the new device relative to the predicate. Most "reported device performance" aspects are stated as "Same" or "Equivalent" to the predicate.

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

This document describes a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device. It is not a performance study (e.g., clinical trial) that would typically involve a "test set" of patient data in the context of diagnostic or AI device evaluation. The "testing" referred to is likely engineering verification and validation testing to ensure the device performs according to its specifications and is safe, similar to the predicate.

Therefore, information on "sample size used for the test set" and "data provenance (e.g., country of origin, retrospective or prospective)" is not applicable or provided for this type of submission.

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

As explained above, there is no "test set" in the context of clinical data for ground truth establishment. This is a medical device (massager), not an AI/diagnostic algorithm using image or patient data requiring expert adjudication of ground truth.

Therefore, this information is not applicable or provided.

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

Not applicable, as there's no clinical "test set" requiring expert adjudication.

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 physical massager, not an AI diagnostic tool or software-as-a-medical-device (SaMD) that would involve human "readers" or AI assistance for interpretation.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the demonstrated safety and effectiveness of the predicate device, against which the new devices are compared through engineering and design analysis, and compliance with standards.

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary of the study/submission:

The "study" in this context is a 510(k) Premarket Notification designed to demonstrate substantial equivalence of the NormaTec Pulse 2.0 and Pulse Pro 2.0 to a previously cleared predicate device (NormaTec Pulse and Pulse Pro, K160608).

The primary method to "prove" the device meets "acceptance criteria" (which are fundamentally demonstrating equivalence) is through a detailed comparison across various aspects:

• Identical Indications for Use.
• Equivalent Design, Technology, and Principle of Operation. The core mechanism (compressor and valve system inflating cells) is the same. The key difference is the addition of Bluetooth capability for app control, which is argued not to alter therapy or add new features, but merely mimic the existing interface.
• Equivalent Performance and Specifications. This refers to parameters like pressure range, treatment time, inflation/deflation cycles, materials, weight, and dimensions (with minor dimension differences noted but not deemed significant).
• Compliance with relevant standards. The new devices comply with the same standards as the predicate, plus an additional one (ANSI C63.27-2017) related to "Bluetooth communication ability."
• Identical Intended Use Environment and Patient Population.

Verification and Validation activities were performed to establish the performance, functionality, and reliability characteristics of the proposed devices with respect to the predicate, demonstrating that they meet defined requirements and performance claims. These V&V activities constitute the "study" that supports the claim of substantial equivalence. The document does not elaborate on the specifics of these V&V activities (e.g., number of units tested, types of bench tests, clinical subjects if any for general use features), as is typical for 510(k) summaries which focus on summarizing the equivalence rather than detailed study protocols.

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The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves (Product Code "JOW"). They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered by an external IEC 60601-1 Power Supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.

The provided text describes a 510(k) premarket notification for the NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 devices. It focuses on demonstrating substantial equivalence to existing predicate devices (NormaTec PCD-B and NormaTec PCD-T K161346) rather than proving de novo acceptance criteria for an AI/ML medical device through a performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.

The provided text concerns a device that applies pressure to extremities for therapeutic purposes, which falls under physical therapy or rehabilitation, not an AI/ML imaging or diagnostic device. The "AI" mentioned is simply a mobile application that mimics the physical device's user interface via Bluetooth, not an artificial intelligence algorithm that performs analysis or makes decisions.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. AI/ML Device Context: The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are compressible limb sleeves. Their core function is mechanical (applying pressure). The "Bluetooth capability" and "NormaTec app" are described as solely mimicking the device's physical interface ("does not provide or unlock any additional features or alter the therapy provided by the device"). This indicates the device does not employ AI/ML for analysis, diagnosis, or treatment planning that would require performance criteria as typically assessed for AI/ML medical devices.

2. Regulatory Pathway: The document is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device. This pathway typically relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons and non-clinical testing (e.g., electrical safety, EMC, performance verification), not necessarily extensive clinical performance studies comparing diagnostic accuracy or AI algorithm performance.

Therefore, the specific information requested in the prompt (acceptance criteria for AI/ML performance, ground truth, expert opinions, MRMC studies, etc.) is not applicable to or present in this 510(k) submission, as it pertains to a different type of medical device and regulatory evidence.

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The NormaTec PCD-T and NormaTec PCD-B are intended to apply pressure to the extremities to treat:

Lymphedema and other edematous conditions, including

• Congenital lymphedema (Millroy's disease, lymphedema praecox, ●
• and lymphedema tarda) ●
• Post-mastectomy lymphedema
• Post-infection lymphedema ●
• Post-traumatic lymphedema .
• . Post-surgical lymphedema
• Post-radiation-treatment lymphedema .
• Venous insufficiency .
• Venous stasis ulceration ●

and to prevent:

Deep Vein Thrombosis

The NormaTec PCD-T and PCD-B are designed to provide noninvasive air compression therapy for the treatment of lymphedema, venous insufficiency, other edemas, and venous stasis ulceration and to prevent deep venous thrombosis.

They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.

The NormaTec PCD-T and PCD-B consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.

The inflatable leg and arm "appliances" and the plastic air tubing are of the same general design and constructions as those cleared in the predicate NormaTec PCD (K013436) the materials are identical. The hip appliance is identical to that in NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608 and uses identical materials. Additionally, the air compressor, valve control are similar to the predicate NormaTec PCD (and are identical to the NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608)

The user interface on the PCD-T model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the PCD-B model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

The provided document is a 510(k) summary for the NormaTec PCD-T and NormaTec PCD-B devices. This type of regulatory submission seeks to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone performance, training set details) is generally not part of a 510(k) submission unless the device introduces new technology or indications for use that differ significantly from the predicate.

In this specific document, the manufacturer relies on a comparison to a predicate device (NormaTec PCD, K013436) and a reference device (NormaTec Pulse and Pulse Pro, K160608) to establish substantial equivalence. Performance testing mentioned is primarily bench testing and compliance with electrical safety and electromagnetic compatibility standards.

Here's an analysis based on the provided text, addressing your questions where information is available:

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

The document does not explicitly state quantitative acceptance criteria for device performance studies in the way you might expect for a novel device proving efficacy. Instead, the "performance" is largely demonstrated by showing substantial equivalence to the predicate device and compliance with relevant safety standards.

The closest we get to "reported device performance" in relation to acceptance criteria is the statement under "Performance Testing": "The device has been tested to ensure that it all requirements have been met, this includes:

• Testing of all controls
• Testing of all indicators
• Testing of battery state indicators
• Testing of performance
• Testing of hazard mitigations"

However, no specific performance metrics (e.g., pressure accuracy, cycle timing accuracy with defined thresholds) or the results against them are provided in this summary. The "acceptance criteria" here implicitly refers to the device functioning as intended and matching the performance characteristics of the predicate, as well as meeting the requirements of the standards listed.

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: Not applicable/not provided. The performance testing described is bench testing, not a study involving human subjects or collected data sets in the typical sense.
• Data Provenance: Not applicable/not provided.

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

Not applicable/not provided. "Ground truth" is typically established in clinical or diagnostic studies. For these devices, the "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and performance.

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

Not applicable/not provided. No clinical test set requiring expert adjudication is described.

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

Not applicable/not provided. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.

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

Not applicable/not provided. This is a physical medical device (compressible limb sleeve), not an algorithm or AI.

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

Not applicable. For this 510(k) submission, the "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, which has already been deemed safe and effective for its intended uses. The performance testing focuses on ensuring the new device operates similarly and meets safety standards.

8. The sample size for the training set

Not applicable/not provided. This is a physical device, not a machine learning model.

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

Not applicable/not provided.

Summary of what was included and relevant for a 510(k) submission:

• Predicate Device Comparison Table (Pages 7-8): This is the core of the substantial equivalence argument. It directly compares the new devices (PCD-T and PCD-B) to the predicate device (PCD K013436) across several attributes, including:

  • Indications for Use (Identical)
  • Contraindications (Identical)
  • Prescriptive (Identical)
  • Power Source (New devices have optional integrated battery)
  • Software/Firmware/Microprocessor Control (Same control technology)
  • Technology (Identical compressor and valve system)
  • Compliance with Voluntary Standards (New devices comply with updated standards and a home use standard)
  • Device Pressure range (Identical)
  • Treatment Time (New devices have added ability to time treatment)
  • Inflation/deflation cycle type (Identical)
  • Appliance contact surface material (Identical)
  • Number of Inflatable appliance segments (Identical)
  • Weight and Dimensions (Similar, new devices are lighter/smaller)
  • Housing Materials and Constructions (Similar)
  • Patient contact (Identical)
  • Appliances (New devices use leg/arm appliances from K013436 and hip appliance from K160608)

• Performance Testing (Page 9):

  • Bench Testing: Described as ensuring "all requirements have been met," including controls, indicators, battery state, overall performance, and hazard mitigations. No specific quantitative criteria or results are provided in this summary.
  • Standards Compliance:
    • AAMI / ANSI ES60601-1:2005 (Medical electrical equipment - basic safety and essential performance)
    • IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
    • IEC 60601-1-11: 2010 (Home healthcare environment)

• No Animal Testing or Clinical Testing was performed.

The conclusion explicitly states "The NormaTec PCD-T and PCD-B are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness." This statement, along with the detailed comparison table and standards compliance, forms the basis of the "proof" that the device meets the implicit acceptance criteria for a 510(k) clearance.

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The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers. They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.

The NormaTec Pulse and Pulse Pro consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.

The inflatable leg and arm "appliances", and the plastic air tubing are identical to the components of the FDA-cleared NormaTec MVP (K112890). The hip appliance is of the same general design and uses identical materials. Additionally, the air compressor, valve, valve control are similar to the predicate NormaTec MVP.

The user interface on the Pulse Pro model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the Pulse model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

Since this is not an AI/ML device, the traditional acceptance criteria and study design for such devices are not applicable.
This document is a 510(k) premarket notification for the NormaTec Pulse and NormaTec Pulse Pro, which are powered inflatable tube massagers. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices.

The acceptance criteria for substantial equivalence in this context are primarily based on comparing the new device to existing predicate devices in terms of:

• Intended Use: The purpose for which the device is used.
• Technological Characteristics: The fundamental scientific technology and design principles.
• Performance: How the device functions and its capabilities.
• Safety and Effectiveness: Ensuring that any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, outlining how the device meets these criteria through comparison with predicate devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states:

• "No animal testing was performed"
• "No clinical testing was performed"

Therefore, there is no "test set" in the sense of patient or animal data used to establish device performance against clinical endpoints. The evaluation for substantial equivalence relied on bench testing and comparison to predicate devices rather than clinical performance data.

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

Not applicable. As no clinical or animal testing was performed, there was no "ground truth" to be established by experts from such test sets regarding clinical outcomes. The "ground truth" for the substantial equivalence claim resides in the technical specifications, design, and performance characteristics compared to the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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 physical therapy device (powered inflatable tube massager), not an AI/ML diagnostic or image reader assistance device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for proving substantial equivalence was based on:

• Technical specifications and design documents of the NormaTec Pulse and Pulse Pro.
• Technical specifications and regulatory clearances of the predicate devices (NormaTec MVP - K112890 and Figg, LLC PowerPlay model PPRT-01 - K122154).
• Bench testing results demonstrating compliance with applicable electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. No training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the NormaTec Pulse and Pulse Pro met acceptance criteria for substantial equivalence was a comparison study against two predicate devices: NormaTec MVP (K112890) and Figg, LLC PowerPlay model PPRT-01 (K122154).

The acceptance criteria were met by demonstrating that the new device:

• Has identical indications for use and contraindications as the primary predicate NormaTec MVP (K112890).
• Utilizes identical core technology (compressor and valve system with sequential inflation).
• Has similar, or improved without raising new safety/effectiveness concerns, technological characteristics (e.g., pressure range, treatment time, controls).
• Complies with relevant, updated voluntary standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-11).
• Key differences (e.g., optional integrated battery, microprocessor control, adjustable treatment time, hip appliance, broader pressure range for hip appliance, different massage patterns) were analyzed and determined not to raise new questions of safety or effectiveness.

This evaluation was supported by bench testing to confirm the device's adherence to various controls, indicators, performance parameters, hazard mitigations, and compliance with the specified electrical and EMC standards. No animal or clinical studies were deemed necessary for this substantial equivalence determination.

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The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec MVP is a powered inflatable tube massager. It is intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation to the treated areas. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff. The device is to be used by people who are in good health.

The NormaTec MVP consists of an air compressor with a manual pressure adjustment bleed-valve, an inflatable appliance (boot or arm sleeve). plastic air fubing connecting the device to the appliances, and an AC/DC adaptor with power cord. The appliance is divided into 5 segments, with a single tube leading from each segment to the tubing connector on the device.

The provided document describes the NormaTec MVP, a powered inflatable tube massager. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance evaluations with specific metrics.

Instead, the document focuses on:

• Substantial Equivalence: The primary method for FDA clearance (510(k)) is by demonstrating that a new device is as safe and effective as a legally marketed predicate device.
• Safety Testing: The document mentions "safety testing and quality assurance testing" were performed, stating that "In all instances, the NormaTec MVP functioned as intended and the results observed were as expected." It also notes compliance with electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). This is a general statement about manufacturing and basic functional checks, not a clinical performance study against specific acceptance criteria for efficacy.
• Intended Use & Technological Characteristics: Details about what the device does and how it works.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as the requested information is not present in the provided text.

Based on the available text, here's what can be inferred or directly stated:

Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable. The document does not specify quantitative acceptance criteria or a performance study with measurable outcomes beyond general safety and functionality.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance (country, retrospective/prospective) is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described for a performance study.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document states: "Performance data demonstrate that the MVP is as safe and effective as the predicate device." This general statement refers to the substantial equivalence argument based on similar design, intended use, and functioning as predicate devices, not a new clinical performance study with defined acceptance criteria and statistical outcomes.

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