Search Results
Found 3 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(273 days)
The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic 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 handpieces.
The massager component of the Alma Lasers Accent UniForm Handpiece 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 Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.
The provided document is a 510(k) summary for a medical device (Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite]), seeking substantial equivalence to predicate devices. It does not describe or conduct a study involving acceptance criteria and reported device performance in the way typically associated with clinical trials or AI/algorithm evaluation.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices based on technical characteristics and safety performance testing rather than clinical efficacy studies with specific performance metrics against a defined ground truth.
Therefore, many of the requested elements for describing an acceptance criteria study and the methodology behind it (like sample size, data provenance, expert ground-truthing, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.
However, I can extract the information that is present concerning the rationale for substantial equivalence and the listed safety performance testing.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance Study Information
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. Instead, the "acceptance criteria" for this submission are compliance with recognized safety standards and demonstration of substantial equivalence in technical characteristics.
| Acceptance Criteria Type (Implicit) | Reported Device Performance (Compliance/Equivalence) |
|---|---|
| Technical & Functional Equivalence | The Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] shares: |
| • The same indications for use. | |
| • The same operation principle. | |
| • Similar technical and functional capabilities as the predicate Accent™ Family of RF Systems (K072699 and K070004). | |
| (See detailed comparison table in Section VI for specific RF frequency, treatment energy, operational modes, etc., all matching predicate devices). | |
| Safety and Essential Performance | Compliance with applicable FDA Recognized Consensus Standards: |
| • IEC 60601-1-2: 2004: Medical electrical equipment Part 1: General requirements for safety: Electromagnetic compatibility | |
| • IEC 60601-1:1988, Amendment 1:1991, Amendment 2:1995: Medical electrical equipment Part 1: General requirements for safety | |
| • IEC 60601-2-2:2006: Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories |
The results of the performance testing showed compliance with these standards. |
| Clinical Equivalence (Implicit) | Based on the above, the device is considered "safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications." (This is a conclusion drawn from the technical and safety equivalence, not from a comparative clinical efficacy study provided in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data. The "performance testing" refers to engineering and electrical safety standards compliance.
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 / Not Provided. No clinical ground truth was established for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No clinical test set or adjudication method 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 / Not Provided. This device is an RF system for dermatologic/surgical procedures, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This device does not feature an algorithm for standalone performance evaluation in the context of AI or diagnostic systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. The "ground truth" for this submission relates to compliance with engineering safety standards and established technical specifications, not clinical outcomes or expert consensus on a diagnostic task.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is not an AI/machine learning system, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No training set exists.
Summary of the Study (as described in the 510(k) Summary):
The "study" described in this document is a regulatory submission demonstrating substantial equivalence rather than a clinical performance study measuring specific outcomes. The primary "studies" conducted were non-clinical performance testing to ensure safety and compliance:
- Type of Study: Non-clinical performance testing for electrical safety and electromagnetic compatibility.
- Purpose: To demonstrate that the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] is as safe and effective as its predicate devices, primarily through compliance with international standards (IEC 60601 series).
- Methodology: The system was tested against the requirements of IEC 60601-1-2: 2004 (electromagnetic compatibility), IEC 60601-1:1988 with amendments (general safety), and IEC 60601-2-2:2006 (particular requirements for high-frequency surgical equipment).
- Conclusion: The tests demonstrated compliance with these standards, supporting the conclusion of substantial equivalence to the predicate devices. This equivalence is based on the device sharing the same intended use, indications for use, operation principle, and similar technical and functional capabilities, alongside meeting safety criteria.
Ask a specific question about this device
(115 days)
The radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in:
- Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
- Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
- Non-invasive treatment of wrinkles and rhytids.
The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool NXT System and Accessories is indicated for use in:
- Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
- Non-invasive treatment of periorbital wrinkles and rhytids;
- Non-invasive treatment of wrinkles and rhytids;
- Temporary improvement in the appearance of cellulite;
- Relief of minor muscle aches and pains;
- Relief of muscle spasms:
- Temporary improvement of local circulation (i.e., blood circulation).
The Thermage ThermaCool NXT System delivers capacitively coupled radiofrequency energy while cooling tissue by conduction. Components and accessories include the Multiplex (16.0) Handpiece, Standard Handpiece, Treatment Tips, Return Pad, Electronic Footswich (optional), Cryogen Canister and Coupling fluid. The front panel of the ThermaCool NXT System is equipped with a receptacle to connect the Return Pad to each Handpiece Assembly, comprising the return path for electric current. The modified Standard Handpiece offers user-selectable vibration to provide concurrent mechanical manipulation of tissue in a manner similar to the predicate devices listed.
This 510(k) submission (K090580) for the Thermage ThermaCool NXT System (TG-2B) provides a safety summary, but it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
The document states in section F, "Summary": "By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool NXT System and Accessories is substantially equivalent to devices currently cleared for marketing in the United States." This indicates that the device was cleared based on substantial equivalence to predicate devices, rather than new clinical effectiveness or performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory classification, predicate devices, and intended use.
Ask a specific question about this device
Page 1 of 1