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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.

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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.

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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.

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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.

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