(216 days)
The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.
The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.
The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Ultrasound Module provides ultrasonic diathermy intended for:
- Relief of pain
- Muscle spasms
- · Joint contractures
- · NOT for the treatment of malignancies
The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
The provided document describes the Accent XL with the Alma Ultra hand piece and its substantial equivalence to predicate devices, primarily for its ultrasonic diathermy function. The document does not contain information on clinical studies involving human patients, human readers, or a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance. The focus is on technical performance bench testing and regulatory equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the performance bench testing conducted and comparison to predicate devices, ensuring it meets similar specifications and safety standards.
| Acceptance Criterion | Reported Device Performance (K160075 Accent XL with Alma Ultra handpiece) |
|---|---|
| Ultrasonic Performance (Compared to Predicate K091615 MC1 General Project) | - |
| Ultrasound Frequency | 1MHz (± 20%) |
| Ultrasonic Intensity | 3W/cm² |
| Max treatment time | 30 minutes |
| BNR (Maximum Beam Non-uniformity Ratio) | 6:1 (within range of predicate K952536 Zimmer Sono 5 which is 6:1, and K091615 MC1 General Project which is 4:1) |
| ERA (Effective Radiating Area) | 1.2 cm² (different from predicates (4.9cm² and 5.0cm²), but deemed not to present new safety/effectiveness concerns as parameters are within ranges used by predicate devices) |
| Electrical Safety & EMC | - |
| IEC 60601-1:05+CORR.1(2006)+CORR.2(2007)+A1:12 | Testing performed in accordance with this standard. |
| IEC 60601-1-2:2007 (edition 3.0) | Testing performed in accordance with this standard. |
| IEC 60601-2-5:2009 | Testing performed in accordance with this standard. |
| Biocompatibility | - |
| ISO 10993-5:1999 | Testing performed in accordance with this standard. Patient contacting material previously cleared in K042000 and K141237. |
| ISO 10993-10:1999 | Testing performed in accordance with this standard. Patient contacting material previously cleared in K042000 and K141237. |
| Performance Bench Testing (Temperature) | - |
| Raise skin temperature to 40-45°C | Achieved in less than 15 minutes. |
| Maintain skin temperature at 40-45°C | Maintained for a minimum of 10 minutes. |
| Treat for 30 minutes with no adverse effects | Device capable of this. |
2. Sample size used for the test set and data provenance
The document describes bench testing, not a clinical study on a patient test set. The sample size for the bench tests is not specified, but it refers to physical testing of the device's electrical, thermal, and mechanical properties. The data provenance is from bench laboratory testing conducted by the manufacturer, not from human subjects or retrospective/prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was regulatory submission based on technical compliance and substantial equivalence, not a study requiring expert-established ground truth for a clinical dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing against predefined technical standards and predicate device specifications, not a study requiring adjudication of clinical findings.
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, an MRMC comparative effectiveness study was not done. This document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device (ultrasonic diathermy) and does not involve AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance bench testing, the "ground truth" was established by engineering and safety standards (e.g., IEC standards for electrical safety, EMC, and ultrasonic physiotherapy equipment) and comparison to the specifications of legally marketed predicate devices. For the temperature performance, the criteria (e.g., raising skin temperature to 40-45°C in less than 15 minutes) served as the ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.