(128 days)
The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.
V12 PRO utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. V12 PRO consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has twelve (12) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
The V12 PRO consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance, and a power cord.
The user interface on the V12 PRO is a Membrane Keypad with dome switches. The settings are shown on a 3.2″ LCD Screen.
The provided text describes the V12 PRO device and its FDA 510(k) clearance application. It focuses on demonstrating substantial equivalence to a predicate device (Ballancer 505 System) rather than providing detailed acceptance criteria and a study dedicated to proving those criteria for the V12 PRO as a standalone device.
However, based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the conducted performance tests. The study's main goal was to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text, with N/A where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance (V12 PRO) |
|---|---|
| 1. Indications for Use Equivalence | The V12 PRO is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation to the treated areas in good health, simulating kneading and stroking of tissues using an inflatable garment. This is deemed similar to the predicate device's indications. |
| 2. Technological Characteristics Equivalence | * Intermittent Pneumatic Compression: Both subject and predicate use this principle. |
- Electronically Controlled Air Pump with Compression Garments: Both possess this core technology.
- Mode of Compression: Sequential Gradient confirmed for V12 PRO. |
| 3. Pressure Distribution Comparability (Safety & Effectiveness) | Based on the Pressure Distribution Comparison Test, while there are a few differences between pressure curves, both products show a similar compression pressure curve in the longitudinal direction. It was concluded that both devices have the same technological characteristics, and V12 PRO has a safety and effectiveness profile similar to the predicate device. |
| 4. Biocompatibility Standard Compliance | The device should be biocompatible for intact skin contact for less than 24 hours. The V12 PRO successfully passed: - Cytotoxicity (ISO 10993-5:2009)
- Irritation (ISO 10993-10:2013)
- Sensitization (ISO 10993-10:2013) |
| 5. Electrical Safety Standard Compliance | The device should comply with relevant electrical safety standards. The V12 PRO complies with: - IEC 60601-1
- IEC 60601-1-11 (Medical electrical equipment: General requirements for basic safety and essential performance) |
| 6. Electromagnetic Compatibility (EMC) Standard Compliance | The device should comply with relevant EMC standards. The V12 PRO complies with: - IEC 60601-1-2:2014 |
| 7. Software Verification and Validation | Software should be verified and validated as per FDA guidance. Software verification and validation testing was conducted, and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." (Specificity on exact "acceptance criteria" for software performance is not detailed in the summary, but successful V&V implies meeting defined functional and safety requirements). |
Study Proving Acceptance Criteria:
The primary "study" described is a non-clinical performance evaluation and comparison to a predicate device conducted to demonstrate substantial equivalence for regulatory clearance (K210913).
Specific Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" in terms of subject or patient count for clinical performance. The testing described focuses on device characteristics, not patient outcomes. The "Pressure Distribution Comparison Test" was performed on the device itself and the predicate.
- Data Provenance: The tests (biocompatibility, electrical safety, EMC, software V&V, pressure distribution) were conducted on the V12 PRO device and compared against the Ballancer 505 System (predicate device). No information on patient data (country of origin, retrospective/prospective) is provided as this was a non-clinical submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This was a non-clinical submission focusing on technical performance and equivalence. No human expert "ground truth" was established for a test set of clinical images or patient outcomes. The "ground truth" for the technical tests would be the established industry standards (IEC, ISO) and the characteristics of the predicate device.
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Adjudication method for the test set:
- N/A. Not applicable as there was no expert adjudication of clinical data or images.
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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 device (V12 PRO) is a powered inflatable tube massager, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm only" performance in the sense of an AI diagnostic. The device's performance is inherently "standalone" in its mechanical and software operation, but it requires human application and setting adjustments. The software verification and validation are essentially demonstrating its "standalone" functionality.
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The type of ground truth used:
- Technical Specifications/Industry Standards: For biocompatibility, electrical safety, EMC, and software, the "ground truth" was compliance with established international standards (ISO, IEC, FDA guidance).
- Predicate Device Characteristics: For the Pressure Distribution Comparison Test, the "ground truth" was the comparable performance (pressure curve) of the legally marketed predicate device, the Ballancer 505 System.
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The sample size for the training set:
- N/A. This document does not describe the development of a machine learning or artificial intelligence algorithm that would require a distinct training set. The "software" mentioned refers to the device's operational control software, which undergoes traditional software verification and validation, not machine learning model training.
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How the ground truth for the training set was established:
- N/A. See point 7.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).