Search Results

For Over-The-Counter Use:

TENS:

ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS/NMES:

ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

For Prescription Use:

TENS:

ManaFlexx2 (MF002-RX) is intended for the following use:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis

PMS/NMES:

ManaFlexx2 (MF002-RX) is intended for the following use:

• Temporary relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Maintaining or increasing range of motion
• Increase of local blood flow in the treatment area
• Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

The ManaFlexx 2 delivers electric pulse generated to the user's body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating elements, such as the ON/OFF button, intensity increase button and intensity decrease button, and there are two snap connectors on the rear of the device which are for connecting with electrode. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, and there is a LED screen to display the selected mode, intensity level and charging status.

The electrode is a long strip shape with a size of 21cm x 5.3cm, its conductive part is black color, and there is white non-conductive area with a width of 1 cm in the middle, which divides the electrode into two parts: positive and negative. There are 2 snap connectors on the electrode used for connection with main unit.

The device has two models have the same appearance, the identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC use.

The provided text is a 510(k) Summary for the ManaFlexx 2 device, a TENS/PMS/NMES unit. It details the device's comparison to predicate devices and summarizes non-clinical performance testing. However, it explicitly states: "Clinical testing was not performed on the device."

This means there is no study described that proves the device meets acceptance criteria based on human-in-the-loop performance, expert consensus, or clinical outcomes. The acceptance criteria and "study that proves the device meets the acceptance criteria" in this document refer exclusively to non-clinical performance testing against recognized standards.

Below is a breakdown of the requested information based only on the provided text, focusing on the non-clinical performance testing mentioned. Many points cannot be answered as they relate to clinical studies that were "not performed."

Device: ManaFlexx 2 (model: MF002-RX, MF002-OTC)

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

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

• Sample Size: For performance testing (bench tests), the sample size is stated as "The test sample is the final, finished product." No specific number is given, but typically this means a small number of units (e.g., 3-5) are tested to demonstrate compliance.
• Data Provenance: The tests are non-clinical, lab-based performance tests against international standards. The 510(k) application is from ManaMed, Inc. (USA) with an application correspondent in Guangzhou, Guangdong, China. The testing likely occurred in a lab affiliated with the manufacturer or a third-party testing facility, potentially in China (where the correspondent is located). The data is generated prospectively as part of the regulatory submission process.

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)

• Not applicable. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) was not established because "Clinical testing was not performed on the device." The "ground truth" for these tests is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC, ANSI AAMI).

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

• Not applicable. This concept applies to human consensus or expert review processes, which were not part of the described non-clinical testing.

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

• No. "Clinical testing was not performed on the device."

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

• No. This device is a physical TENS/PMS/NMES unit, not an AI algorithm. The performance tests are for the electrical and mechanical functions of the device itself.

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

• The "ground truth" for the non-clinical tests is the adherence to the published performance specifications and limits defined by the referenced international consensus standards (e.g., IEC 60601 series, ANSI AAMI ES60601-1). This is a technical standard compliance model, not a clinical "ground truth."

8. The sample size for the training set

• Not applicable. The device is a physical stimulator, not an AI/ML model that requires a training set of data.

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

• Not applicable, as there is no training set for an AI/ML model for this device.

Ask a specific question about this device

Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.

• 2. Pain relief, muscle spasms, and joint contractures.
• 3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
• · Adhesive capsulitis,
• · Bursitis with slight calcification,
• · Myositis,
• · Soft tissue injuries, and
• · Shortened tendons due to past injuries and scar tissues.
• 4. Relief of pain, muscle spasms, and joint contractures resulting from:
• · Capsular tightness, and
• · Capsular scarring.
• 5. Localized increase in blood flow.
• 6. Increased range of motion of contracted joint using heat and stretch techniques.

The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.

The provided text is a 510(k) summary for the ManaSport+ device, an ultrasonic diathermy device. It discusses the device's substantial equivalence to predicate devices, focusing on its technical characteristics and indications for use. However, it explicitly states that "Clinical testing was not provided in support of this 510(k) application," and therefore, there is no study described that proves the device meets specific performance acceptance criteria via clinical data, nor is there information on ground truth establishment, expert consensus, or MRMC studies.

The document primarily relies on non-clinical testing and comparison to predicate devices, demonstrating substantial equivalence rather than proving performance against quantified clinical acceptance criteria.

Therefore, many of the requested details about acceptance criteria, the study proving the device meets them, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document focuses on demonstrating that the ManaSport+ is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices, and does not require a new Premarket Approval Application (PMA). This is achieved through non-clinical testing and a comparison of technical specifications.

Here's what can be extracted based on the provided text, while noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of clinical performance acceptance criteria and reported device performance against those criteria. Instead, it provides a "Summary of Substantial Equivalence" comparing the ManaSport+ (Subject Device) to its primary predicate (ManaSport) and another predicate (sam 2.0 Long Duration Ultrasound System) based on various technical parameters. The "Equivalence" column in this table indicates if the subject device's parameter is identical, similar, or different, and explains why any differences do not affect safety or effectiveness.

Below is a partial example of how the provided table could be structured to show the comparison, but it's crucial to understand these are technical specifications for substantial equivalence, not clinical performance metrics against acceptance criteria.

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

• Sample Size for Test Set: Not applicable. The document states, "Clinical testing was not provided in support of this 510(k) application." The testing primarily involved non-clinical, bench testing to verify compliance with electrical safety, EMC, and biocompatibility standards, and software verification. There are no "test sets" in the context of clinical or AI performance evaluation.
• Data Provenance: Not applicable for a clinical test set. The document refers to compliance with ISO and IEC standards, which are international standards.

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

• Not applicable. As no clinical testing was performed, no ground truth was established by experts for a test set.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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

• No, an MRMC study was not done. The document explicitly states "Clinical testing was not provided."

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

• Not applicable. The ManaSport+ is a physical device (ultrasonic diathermy), not an AI algorithm. Its performance is related to its physical outputs (e.g., ultrasound frequency, power, temperature rise in tissue), which were evaluated through non-clinical bench testing for compliance with standards.

7. The Type of Ground Truth Used

• Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" refers to the established requirements and specifications of the cited voluntary standards (e.g., IEC 60601-1, ISO 10993) which the device's measured performance was compared against.

8. The Sample Size for the Training Set

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

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

• Not applicable. No training set for an AI algorithm.

Summary of Device Performance and Acceptance Criteria (Based on Non-Clinical Data):

The ManaSport+ device demonstrated performance primarily through non-clinical tests to ensure compliance with recognized voluntary standards for medical devices. The "acceptance criteria" here are the requirements outlined in these standards for:

• Electrical Safety: IEC 60601-1, IEC 60601-2-5 (for ultrasonic physiotherapy equipment)
• Electromagnetic Compatibility (EMC): IEC 60601-1-2
• Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization)
• Home Healthcare Environment Requirements: IEC 60601-1-11
• Usability: IEC 60601-1-6
• Software Verification: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The document asserts that the device conformed to or complied with these standards. For example, regarding temperature rise, it states "Meets IEC 60601-2-5, section 201.11 Protection against excessive temperature and other HAZARDS." Specific values for temperature rise in tissue are also given (e.g., "7.6°C at 1 cm / 3.3°C at 2 cm / 1.4°C at 3 cm / Max treatment time: 20 min"), and these are compared to the predicate devices as "Identical or similar. This value of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, it does not affect the safety or effectiveness."

In conclusion, for the ManaSport+ device, its "acceptance criteria" were primarily defined by compliance with a comprehensive set of international electrical safety, EMC, biocompatibility, and usability standards, and its "performance" was demonstrated through non-clinical testing against these standards, as well as by showing substantial equivalence to existing cleared devices with similar indications for use. No clinical trial data was submitted or required for its 510(k) clearance.

Ask a specific question about this device

Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.

• 2. Pain relief, muscle spasms, and joint contractures.
• 3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
• · Adhesive capsulitis.
• · Bursitis with slight calcification,
• · Myositis,
• · Soft tissue injuries, and
• · Shortened tendons due to past injuries and scar tissues.
• 4. Relief of pain, muscle spasms, and joint contractures resulting from:
• · Capsular tightness, and
• · Capsular scarring.
• 5. Localized increase in blood flow.
• 6. Increased range of motion of contracted joint using heat and stretch techniques.

Not Found

This is a medical device clearance letter for the ManaSport ultrasonic diathermy device. The provided text is not a clinical study report and does not contain the information requested about acceptance criteria, study design, or performance metrics for an AI/algorithm-based device.

The document discusses the regulatory clearance process for a traditional medical device (ultrasonic diathermy) under a 510(k) submission, confirming its substantial equivalence to previously marketed devices. It outlines general regulatory requirements and lists the device's indications for use.

Therefore, I cannot provide the requested information, such as:

1. Table of acceptance criteria and reported device performance: This information is not present.
2. Sample size for test set and data provenance: Not applicable to this type of regulatory document.
3. Number of experts and qualifications for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study or effect size: This is not an AI-assisted device, so this is not relevant.
6. Standalone (algorithm only) performance: This device is not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document focuses on the regulatory clearance of a physical device, not the performance evaluation of an AI algorithm.

Ask a specific question about this device

The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients blood flow in the extremities (stimulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation:
• · Diminish post-operative pain and swelling;
• · Reduce wound healing time;
• Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
  The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).
The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and a LCD display provide user interface. There are also two tubing ports for connecting the tubing and a charging port for connecting the battery charger/AC adapter at the bottom of the control unit.

The provided text does not contain detailed information about a study proving the device meets acceptance criteria. Instead, it describes a 510(k) premarket notification for the "PlasmaWave" device, asserting its substantial equivalence to predicate devices (PlasmaFlow and Cirona 6200 Deep Vein Thrombosis Prevention System).

Therefore, I cannot provide all the requested information. However, I can extract what is available regarding acceptance criteria and the methods used to demonstrate substantial equivalence.

Here's a summary based on the provided text:

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

The document presents a comparison table (Table 1) between the subject device (PlasmaWave) and two predicate devices (PlasmaFlow, K160318; Cirona 6200, K141578) to demonstrate substantial equivalence. It implies that the "acceptance criteria" are met if the subject device is either identical or sufficiently similar to the predicate devices without raising new issues of safety or effectiveness.

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

The document does not describe a clinical "test set" in the sense of patient data used for evaluating the device's clinical performance. The evaluation is based on a comparison to predicate devices and non-clinical bench tests.

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

Not applicable. There is no mention of experts establishing ground truth for a clinical test set.

4. Adjudication method for the test set

Not applicable. There is no clinical test set mentioned.

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. The device is a pneumatic compression pump, not an AI-assisted diagnostic or imaging device. There is no mention of human readers or AI assistance.

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

Not applicable. This is not an algorithm-only device. The submission relies on demonstrating substantial equivalence to a mechanically similar predicate device.

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

For the purpose of the 510(k) submission, the "ground truth" for "acceptability" is implicitly established by the legally marketed predicate devices. The subject device is deemed acceptable if it can demonstrate substantial equivalence to these predicates without raising new questions of safety or effectiveness. This is supported by:

• Comparison of technical characteristics: Detailed feature-by-feature comparison.
• Compliance with voluntary standards: Adherence to established safety and electromagnetic compatibility standards (ANSI AAMI ES60601-1, IEC 60601-1-2).
• Bench tests: Verification of physical, electrical, and performance requirements.
• Software verification: According to FDA guidelines.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Not applicable. No training set is mentioned.

Ask a specific question about this device

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

• · Treatment of lymphedema
• · Treatment of chronic venous insufficiency
• · Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
• · Reducing venous leg ulcer healing time
• · Reducing edema due to venous stasis
• Enhancing venous return
  The device is intended for home, and hospital use.

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT).
The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.

The provided text is a 510(k) summary for the ManaFlow device, a compressible limb sleeve system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., sample size for test set, number of experts for ground truth, MRMC studies, effect size, standalone performance, type of ground truth) is not present in this document.

The document describes non-clinical tests performed to validate the design and assure conformance with voluntary design standards related to electrical safety and electromagnetic compatibility, as well as bench tests for physical, electrical, and performance requirements, and software verification. However, it does not provide specific performance metrics or acceptance criteria for those tests.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria for clinical performance or detailed quantitative results from those tests. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, functions, design, and adherence to electrical safety and EMC standards.

The closest to a "table of performance" is the comparison table (Table 1) which highlights identical or similar characteristics between the ManaFlow device and its predicates. This table, however, is for comparison of features and design principles, not for reporting quantitative performance against defined acceptance criteria.

Regarding Clinical Study Details (information missing from this 510(k) summary):

2. Sample sizes used for the test set and the data provenance: This document does not describe any clinical test set using patient data. The tests mentioned are non-clinical (bench tests, electrical safety, EMC).
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 test set using expert opinion for ground truth is described.
4. Adjudication method for the test set: Not applicable, as no clinical test set requiring 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. This device is a physical medical device (compressible limb sleeve and pump), not an AI/imaging diagnostic device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used: For the non-clinical tests and substantial equivalence determination, the "ground truth" is largely defined by established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the performance characteristics of predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data).
8. The sample size for the training set: Not applicable, as this is not a machine learning device requiring a training set in the AI sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to "proof":

The document demonstrates that the ManaFlow device meets the requirements for 510(k) clearance by proving substantial equivalence to legally marketed predicate devices. This is achieved by:

• Showing identical intended use and indications for use.
• Comparing design features and specifications: Table 1 meticulously compares ManaFlow's characteristics (e.g., operating principles, contraindications, target population, portability, pressure source, operating modes, working pressure, cycle time, alarms, sterility, materials) to its four predicate devices, highlighting they are identical or similar, and arguing that any differences do not raise new safety or effectiveness concerns.
• Conducting non-clinical tests:
  • Electrical Safety: Conformance to ANSI AAMI ES60601-1 standards.
  • Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2 standards.
  • Bench Tests: Performed for physical requirements, electrical requirements, and performance requirements. (Specific results or acceptance criteria for these bench tests are not detailed in this summary).
  • Software Verification: Carried out according to FDA guidance for software in medical devices.
• Biocompatibility: Stated that skin contact components are identical to those of previously cleared devices (K160318 and K142640), thus confirming biocompatibility without new concerns.

The core of the "proof" is that the ManaFlow device functions fundamentally the same way, has the same intended use, and has passed the necessary engineering and safety tests as similar devices already on the market, thereby establishing it as "substantially equivalent" rather than requiring a de novo clinical trial to prove a new performance claim.

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The PlasmaFlight is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. This device can be used to:

• Temporarily increase blood circulation in the treated areas;
• Temporary relief of minor muscle aches and pains.

The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
The PlasmaFlight, supplied clean and non-sterile, utilizes the pneumatically controlled air bladder cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable cuff. An ON/OFF button and LED indicators/displays provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of an air bladder encased inside a soft medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing the air bladder is permanently connected to the control unit. And the control unit then inflates the cuff to the default predetermined pressure (55 mmHg). The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the air bladder reaches the proper level, the pump is turned off for a rest period, and the cuff deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the unit is turned off.

The provided text describes the 510(k) summary for the device "PlasmaFlight," a portable inflatable tube massager. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical characteristics and compliance with voluntary standards, rather than extensive clinical efficacy studies with specific acceptance criteria and detailed performance claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement for ground truth, and MRMC studies are not present in this document. The document's purpose is to show equivalence and safety/effectiveness via design and performance testing against standards, not to prove clinical performance against new acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to the predicate device.

Here's an attempt to answer your questions based on the provided text, indicating "Not explicitly stated" where the information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria for clinical performance or a reported device performance in terms of efficacy metrics (e.g., specific percentage increase in blood circulation, or reduction in pain levels). Instead, it focuses on demonstrating that the PlasmaFlight's specifications and functions are "Identical or similar" to the predicate device, thereby showing "Substantial Equivalence".

The "acceptance criteria" for this submission would implicitly be that the device's characteristics and performance, as demonstrated through non-clinical tests and comparison, do not raise new questions of safety or effectiveness compared to the predicate device.

Here's a table summarizing the comparisons (which serve as the basis for "acceptance" in a substantial equivalence claim):

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

• Sample Size for Test Set: Not explicitly stated. The submission relies on "Non-Clinical Tests" (bench tests) and comparison to the predicate device, not a specific clinical test set involving human subjects to evaluate new performance metrics.
• Data Provenance: Not applicable for clinical data. The "tests" mentioned are non-clinical (bench tests) and compliance with standards.

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

• Not applicable. This is a 510(k) submission for a physical therapy device demonstrating substantial equivalence, not an AI/imaging device requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring adjudication in this 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

• No. This is not an AI/imaging device, and no MRMC study was conducted or is relevant for this type of submission.

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

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

7. The Type of Ground Truth Used

• The "ground truth," in the context of this submission, is effectively the established safety and effectiveness profile of the legally marketed predicate device and compliance with recognized voluntary standards for medical device safety and performance. There is no "ground truth" derived from expert consensus, pathology, or outcomes data for new clinical claims.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning/AI device that requires a training set.

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

• Not applicable. This is not a machine learning/AI device, so there is no training set or associated ground truth.

Summary of the Study Proving Substantial Equivalence:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to the predicate) is primarily a comparative analysis of technical characteristics and non-clinical bench testing.

• Non-Clinical Tests Performed:

  • Design Validation and Conformance with Voluntary Standards:
    • ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)" - for electrical safety.
    • IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests" - for electromagnetic compatibility.
  • Bench Tests: Performed on physical requirements, electrical requirements, and performance requirements.
  • Software Verification: Carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (as the device uses a microprocessor).

• Conclusion: The tests and comparison performed demonstrate that the PlasmaFlight is substantially equivalent to the predicate device, implying it is as safe and effective as the legally marketed predicate device. The minor differences noted (e.g., in power supply details, charging time, dimensions, weight, operating modes, working pressure, cycle time, cleaning, disposal) were deemed not to raise any new issues of safety or effectiveness.

Ask a specific question about this device

The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation;
• · Diminish post-operative pain and swelling;
• · Reduce wound healing time;
• Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
  The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a nonserviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection.

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The housing on the garment is a lightweight, rechargeable battery-powered, electromechanical control unit intended to provide and digitally monitor through two LED screens the inflation cycle for enhanced circulation therapy. The controller on the sleeve allows the unit to inflate distal to proximal. It is intended to be used in the home, travel situations where altitude or lack of mobility occurs, or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).

All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection. The pump has two LED screens. The screen allows the prescriber and or patient to verify the pressure, the mode, and total run time.

The Patient Sleeve is a single Polyvinyl Chloride (PVC) air bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the calf of a patient. A compression unit with two LED screens is connected to sleeve for a completely ambulatory system. The compression unit has the ability to produce different compression modalities.

Default modality will be the same as the predicated devices, which is, a slow inflation up to 55 mmHg of air through the bladder cells. Once pressure is reached, the unit will deflate for approximately 50 seconds. Then the cycle repeats.

Another compression modality will be the step up technology that inflates the air cells at an increase of 10 mmHg pausing at increments of ten to 50 mmHg, with a final increase of 5 mmHg to 55mmHg. Once 55 mmHg is reached, the unit will decrease to 50 mmHg and then decrease in increments of 10 mmHg.

A single touch control switch located on the top of the unit powers on the unit and switches the mode.

Above the power button, a dual color LED light allows the user to verify for power on, low battery, charging and charge completed indication, and an audible alarm (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug/USB chord.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from a Polyester blended medical fabric or equal, which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs.

In operation, the user simply runs the power ON via the multi-purpose control button. A single user "cuff containing air bladders is connected to the unit. The control unit then fills the cuff to a pressure of 55 mmHg. Cuff pressure is visually monitored by user pressure LED screen, internal pressure switch, and system software. Once the pressure reaches the proper level, the pump is deflated for an approximately 50 second deflate period. The device software ensures the cycle time is a minimum of 60 seconds (the cycle time is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). The cycle repeats until the unit is turned off.

This document is a 510(k) Premarket Notification for the PlasmaFlow device, which is an intermittent pneumatic compression system intended for preventing Deep Vein Thrombosis (DVT) and improving blood circulation. The submission argues for substantial equivalence to a predicate device, the Innovamed Health Venapro (K133274).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for device performance metrics. Instead, it argues for substantial equivalence by comparing the PlasmaFlow (subject device) with the Venapro (predicate device) across various characteristics and showing that they are either identical or that any differences do not raise new questions of safety or effectiveness.

However, based on the non-clinical testing performed, we can infer some performance aspects:

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

The submission explicitly states: "No clinical testing was performed on the PlasmaFlow to support the decision of substantial equivalence."

Therefore, there is no specific sample size or test set derived from clinical data for the PlasmaFlow device itself mentioned in this document. The data provenance related to "clinical studies" refers to results from predicate devices and not studies conducted on the PlasmaFlow. The non-clinical testing was in-house bench testing and outside laboratory testing.

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

As no clinical testing was performed on the PlasmaFlow and no specific test set data is presented for human interpretation, this information is not applicable to the PlasmaFlow device within this 510(k) submission.

4. Adjudication Method for the Test Set

Again, since no clinical test set for human interpretation was used for the PlasmaFlow device, this information is not applicable.

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 PlasmaFlow is an intermittent pneumatic compression device, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study is not applicable as there are no "human readers" interpreting images or data with or without AI assistance in this context.

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

The PlasmaFlow is a mechanical compression device, not an algorithm. Therefore, standalone algorithm performance is not applicable. The non-clinical testing (bench testing, electrical safety, EMC, etc.) can be considered "standalone" in the sense that it evaluates the device's technical performance independently.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the PlasmaFlow device based on non-clinical testing:

• Bench Testing: The ground truth for performance metrics like pressure delivery, cuff fill time, and cycle time was established through objective measurements against defined specifications (e.g., 55 mmHg pressure, 60-second cycle time). These are quantifiable engineering parameters.
• Biocompatibility: Ground truth was established through laboratory testing protocols (e.g., ISO 10993 series) to detect cytotoxicity, sensitization, and irritation.
• Electrical Safety & EMC: Ground truth was established by conformance to international safety standards (e.g., IEC 60601 series), involving specific test procedures and measurements.
• Risk Management: Conformance to quality management system standards (e.g., ISO 14971, ISO 13485).

For the clinical effectiveness for similar devices (predicates): The document refers to published clinical studies evaluating intermittent pneumatic compression devices, which would typically rely on clinical outcomes data (e.g., DVT incidence, blood flow measurements, reduction in pain/swelling). However, these studies were not specific to PlasmaFlow.

8. The Sample Size for the Training Set

As the PlasmaFlow is a mechanical medical device and not an AI/algorithm-based system requiring a "training set" of data, this concept is not applicable.

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

Since a "training set" is not applicable, this information is not relevant.

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