(86 days)
The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.
The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).
The provided text is a 510(k) Summary for the VMAT PRO device, seeking substantial equivalence to a predicate device (D-Actor 200 Vibration Massage System). It focuses on demonstrating that the new device is as safe and effective as the legally marketed predicate. However, this document does not describe a study involving human readers, AI assistance, or the establishment of ground truth by multiple experts for a test set.
The closest information provided is about performance testing to establish that the VMAT PRO control unit performs as intended, and a comparison of its technological characteristics with the predicate device.
Therefore, I cannot fully address all the points in your request as the information is not present in the provided document. I will fill in what can be inferred and explicitly state where information is missing.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a threshold that must be met. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing various technical specifications. The acceptance criterion is implicit: the device's performance characteristics must be sufficiently similar to the predicate device, or any differences must not impact safety or efficacy.
| Characteristic | Predicate Device (D-ACTOR® 200 K173692) | VMAT PRO (K243488) | Comparison / Reported Performance vs. Implicit Acceptance Criteria (Similarity to Predicate) |
|---|---|---|---|
| Indications for Use | Relief of minor muscle aches and pains, temporary increase in local blood circulation, activation of connective tissue. | Relief of minor muscle aches and pains, temporary increase in local blood circulation, activation of connective tissue. | Identical. Meets implicit acceptance criteria. |
| Modes of action | Radial pressure waves, or extracorporeal pulse activation respectively | HP-AT pressure pulse handpiece | Same. Meets implicit acceptance criteria. |
| Mechanism of action | Pneumatically generated vibrations | Pneumatically generated vibrations | Same. Meets implicit acceptance criteria. |
| Type of acoustic wave generation | Pneumatic/ballistic | Pneumatic/ballistic | Same. Meets implicit acceptance criteria. |
| Pulse repeat rate (1/s) | 1-21 Hz | 1-21 Hz | Same. Meets implicit acceptance criteria. |
| Maximum & Minimum Intensity setting | 1-5 bar | 0.5-5.0 bar | Very similar. VMAT PRO goes slightly lower (0.5 bar vs 1 bar), but this is stated to make it more comfortable for patients and not impact safety. Meets implicit acceptance criteria. |
| Type of application | Continuous vibration at a fixed frequency | Continuous vibration at a fixed frequency | Same. Meets implicit acceptance criteria. |
| Driving power | 1-5 bar | 1-5 bar | Same. Meets implicit acceptance criteria. |
| Projectile Mass (g) | 3.0 g | 3.1 g | Same. Meets implicit acceptance criteria. |
| Pulse repeat rate | 1-21Hz | 1-21Hz | Same. Meets implicit acceptance criteria. |
| Number of pulses | variable | Variable | Same. Meets implicit acceptance criteria. |
| Max & Min displacement of applicator heads | 0.6 – 2.0 mm | VAT220: Max: 1.230 mm / Min: 0.350 mm | |
| VAT215: Max: 0.320 mm / Min: 0.120 mm | |||
| VAT120: Max: 1.300 mm / Min: 0.700 mm | |||
| VAT 135: Max: 0.760 mm / Min: 0.300 mm | Different. However, the document states measurements were taken differently (ultrasound in laboratory) and the difference is minimal and does not pose a risk. Meets implicit acceptance criteria. | ||
| Pressure | 1-5 bar | 0.5-5.0 bar (7.25 psi - 72.5psi) | Very similar. Same justification as for intensity setting. Meets implicit acceptance criteria. |
| Beam Pressure Maximum (BPM) | According to modified protocols from IEC 61846 N/A | According to IEC 63045 (at 5 bar) | |
| VAT 220: 45.8 mJ | |||
| VAT 215: 34 mJ | |||
| VAT 120: 24 mJ | |||
| VAT 135: 34 mJ | Different measurements. Due to different standards (IEC 61846 vs IEC 63045). Document explains term "derived focal acoustic pulse energy" is not applicable as device has no focus. VMAT PRO values are within usual range for pressure pulse devices. Implicitly meets acceptance criteria via explanation. | ||
| Total Derived focal acoustic pulse energy | 5bar/6.5mJ | ||
| 3bar/2.4mJ | N/A (term not applicable) | Different measurements/terminology. Explained by standard differences and device nature (no focus). Implicitly meets acceptance criteria via explanation. | |
| Positive derived acoustic pulse energy | Not explicitly stated for predicate in this format | According to IEC 63045 (measured for VAT220 at 5bar) | |
| VAT 220: 39.9 mJ | |||
| VAT 215: 23 mJ | |||
| VAT 120: 17 mJ | |||
| VAT 135: 32 mJ | Explained by standard differences allowing for comparison via BPM. Implicitly meets acceptance criteria via explanation. | ||
| Positive peak pressure | Values of ultrasonic pulse: | ||
| 5bar/18.5MPa | |||
| 3bar/13.4MPa | VAT220: 5 bar: 8.1 MPa / 3 bar: 6.7 MPa | ||
| VAT215: 5 bar: 11.3 MPa / 3 bar: 8.1 MPa | |||
| VAT120: 5 bar: 6.3 MPa / 3 bar: 4.9 MPa | |||
| VAT 135: 5 bar: 3.8 MPa / 3 bar: 2.8 MPa | Different. Due to different testing methodology. Implicitly meets acceptance criteria via explanation. | ||
| Negative peak pressure | Values of ultrasonic pulse: | ||
| 5bar: 6.8MPa | |||
| 3bar: 5.0MPa | VAT220: 5 bar: 6.5 MPa / 3 bar: 5.1 MPa | Same as VAT220. (Predicate transmitter not specified). Implicitly meets acceptance criteria. | |
| Derived pulse-intensity integral (Energy Flux Density) | Values of ultrasonic pulse according to modified protocols from IEC 61846: | ||
| 5bar: .284 mJ/mm2 | |||
| 3bar: .176 mJ/mm2 | VAT220: 5 bar: 0.267 mJ/mm2 / 3 bar: 0.152 mJ/mm2 | ||
| VAT215: 5 bar: 0.224 mJ/mm2 / 3 bar: 0.135 mJ/mm2 | |||
| VAT120: 5 bar: 0.252 mJ/mm2 / 3 bar: 0.187 mJ/mm2 | |||
| VAT 135: 5 bar: 0.207 mJ/mm2 / 3 bar: 0.129 mJ/mm2 | Different but very close. Stated as nearly identical and "key specification to compare." Implicitly meets acceptance criteria. | ||
| Maximum penetration depth | Not explicitly stated for predicate | VAT 220: 33.1 mm | |
| VAT 215: 23.1 mm | |||
| VAT 120: 32 mm | |||
| VAT 135: 35 mm | Different. Stated that differences are within 1mm of predicates (implying predicate data was known but not fully listed here) and do not impact safety or efficacy. Implicitly meets acceptance criteria. | ||
| Working mode | Continuous | Continuous | Same. Meets implicit acceptance criteria. |
| Rise time (measured at 5bar (10%-90%) (μs)) | Not explicitly stated for predicate | VAT220: 4.97 μs | |
| VAT215: 2.41 μs | |||
| VAT 120: 4.28 μs | |||
| VAT 135: 4.16 μs | Similar. Within standard range for pressure pulse devices. Implicitly meets acceptance criteria. | ||
| Compressional pulse duration (measured at 5 bar in μs) | Ultrasonic pulse: 5 μs | VAT220: 6.6 μs | |
| VAT215: 2.93 μs | |||
| VAT120: 4.78 μs | |||
| VAT 135: 6.96 μs | Similar. Within standard range for pressure pulse devices. Implicitly meets acceptance criteria. | ||
| Power Supply | Not explicitly stated for predicate | 230 VAC 50 Hz | |
| 115 VAC 60 Hz (optional with reference M93AF) | No direct comparison to predicate possible from provided table. Assumed to be compatible or safe. | ||
| Maximum operating Temperature | 10-40c | 18-30C | Within predicate's range. Meets implicit acceptance criteria. |
| Treatment heads | 4: 6mmOD, 15mmOD, 20mmOD, 35mmOD | 4: 20mm, 20mm, 35mm, 15mm | Similar sizes. Meets implicit acceptance criteria. |
| Patient Contacting Materials | Steel | Titanium, Stainless Steel, Polyoxymethylene | Similar for transmitters, different for transmitter casing. All materials tested for biocompatibility and found biocompatible. Meets implicit acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes technical and performance testing of the device itself (e.g., electrical safety, EMC, acoustic characteristics), not a clinical study or a study involving a "test set" of patient data for AI evaluation. Therefore, this information is not applicable to this 510(k) summary. The testing refers to the device unit's performance, not a dataset.
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. This document does not concern an AI/clinical diagnostic device requiring expert adjudicated ground truth. The "ground truth" for the device's technical specifications is established through engineering and physical measurements according to international standards (IEC).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As no diagnostic test set is used, no adjudication method is relevant.
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. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission." Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm but a physical therapeutic device. The "performance testing" described refers to the device's physical and electrical characteristics as per IEC standards, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical characteristics comparison, the "ground truth" is derived from:
- Engineering measurements and specifications of the VMAT PRO device itself, conducted in a laboratory setting (e.g., "measured in a laboratory, using ultrasound" for applicator displacement).
- Published specifications of the predicate device (D-Actor 200) from its own 510(k) submission or technical documentation.
- Adherence to international standards such as IEC 60601-1, IEC 60601-1-2, and IEC 63045:2020 for safety, EMC, and ultrasonic characteristics.
- Biocompatibility testing according to ISO 10993-1:2018.
For the purpose of this 510(k) submission, the "ground truth" is primarily device-centric technical specifications and compliance with recognized standards, not clinical diagnostic outcomes or human expert interpretations of patient data.
8. The sample size for the training set
Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.