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510(k) Data Aggregation
(111 days)
The family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos(significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and periorbital wrinkles.
The CoolGlide lasers are also indicated for the removal of unwanted hair, for the stable long term. or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Optional Pulsed Light Hand Piece:
For the treatment of benign pigmented lesions.
Surgical Applications ::
The lasers are indicated for the incision/excision and cutting, ablation. coagulation/hemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy, gastroenterology, g general surgery, surgery, g head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
Indications for use (532nm):
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
The Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are comprised of the following main components:
- · a laser system console (including software and control electronics);
- · a control and display panel;
- · a permanently attached fiberoptic-coupled handpiece;
- · a skin cooling device integrated into the handpiece;
- a footswitch
- · a remote interlock connector (disables laser when treatment room door is opened)
- · optional pulsed light hand piece that can be removed by either the user or a qualified service person.
The provided text is a 510(k) summary for the Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece. This document is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study reporting specific performance metrics against acceptance criteria for a new, novel AI/software-as-a-medical-device (SaMD) product.
Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, specific device performance, study methodology, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies for an AI/SaMD.
The document primarily focuses on:
- Predicate Devices: Identifying existing legally marketed devices to which the new device is substantially equivalent.
- Indications for Use: Listing the medical conditions and applications for which the device is intended.
- Technological Equivalence: Stating that the new device shares similar design features and functional features with predicate devices.
- Safety and Effectiveness: Concluding that no new questions of safety or effectiveness are raised because it's substantially equivalent to existing devices.
Based on the provided text, I cannot fill out the requested table or provide the specific details of a study proving the device meets acceptance criteria. The document does not describe a study in the sense of demonstrating a novel device's performance against predefined metrics, but rather argues for substantial equivalence to devices already on the market.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics are provided. The "performance" is implicitly tied to being "substantially equivalent" to predicate devices, meaning it performs similarly to already cleared devices for the stated indications.
- Sample Size for Test Set and Data Provenance: This information is not relevant to a substantial equivalence argument based on predicate devices. There is no independent "test set" described for performance validation.
- Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no independent ground truth establishment for a novel performance claim.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned, as this is typically for evaluating human performance with and without AI assistance, which is not the context here.
- Standalone Performance: While the device functions as standalone hardware, there isn't a "standalone algorithm performance" study as would be seen for AI/SaMD.
- Type of Ground Truth: No specific ground truth is described as being used for performance validation of this device.
- Sample Size for Training Set: Not applicable, as this is not an AI/ML device that requires a training set.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, this document is a regulatory submission for a medical device based on substantial equivalence, not a scientific publication detailing performance studies for a novel or AI-powered device.
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(232 days)
EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
The provided text is a 510(k) summary for the EpiLight® and PhotoDerm® HR devices, which are electro-optical medical devices for hair removal. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Based on the information given, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) for a new device's performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through technical comparisons and clinical trials.
The primary performance claim for the EpiLight® and PhotoDerm® HR is:
- Permanent hair reduction: Defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The document states that a technical comparison and clinical trials were performed to establish substantial equivalence. However, no specific performance metrics resulting from these studies are provided in this summary.
| Acceptance Criteria (Implicit from Intended Use) | Reported Device Performance |
|---|---|
| Removal of unwanted hair | Achieved (by substantial equivalence to predicates) |
| Stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles | Achieved (by substantial equivalence to predicates) |
| Permanent hair reduction: a long-term stable reduction in the number of hairs regrowing after a treatment regime. | Achieved (by substantial equivalence to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical trials were performed by ESC Medical Systems," but it does not provide any details about:
- The sample size of the test set (number of participants or observations).
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The devices described are medical devices for hair removal, not AI-assisted diagnostic tools requiring reader interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The devices are physical medical devices for hair removal, not AI algorithms.
7. The Type of Ground Truth Used
Given the nature of the device (hair removal), the "ground truth" for "permanent hair reduction" would most likely be based on clinical observation and measurement of hair regrowth over time following a treatment regime. However, the document does not explicitly state the method for establishing this ground truth (e.g., photographic assessment, hair count, patient self-reporting, etc.).
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable.
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