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510(k) Data Aggregation
(42 days)
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:
- Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
- Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm
The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.
The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths.
The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.
The provided document is a 510(k) summary for the BEAMAX/ FORMAX Pulsed Light Device Family. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a new clinical study to establish acceptance criteria and device performance from scratch. Therefore, many of the typical elements of a study that prove a device meets acceptance criteria are not present.
However, based on the information provided, here's an attempt to answer the request by interpreting "acceptance criteria" as the criteria for substantial equivalence, and "study" as the comparison to predicate devices:
Acceptance Criteria and Device Performance Study for BEAMAX/FORMAX Pulsed Light Device Family
Overview
The BEAMAX/FORMAX Pulsed Light Device Family sought 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices, as opposed to conducting a de novo clinical trial with new performance acceptance criteria. The "acceptance criteria" here therefore refer to the criteria for substantial equivalence, and the "reported device performance" is framed by its similarity to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission, the "acceptance criteria" are the conditions under which the device is considered substantially equivalent to already cleared devices. The "reported device performance" is essentially that it matches or is comparable to these predicate devices for the specified indications.
| Criteria Category | Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Intended Use | Identical to legally marketed predicate devices. | The intended use and indications of the submitted BEAMAX/FORMAX family are identical to legally marketed devices: BEAMAX (K063249), Harmony XL™ (K072564), and Cutera (K050047). |
| Indications for Use | Identical or comparable to legally marketed predicate devices, without raising new questions of safety/effectiveness. | The proposed device family includes broader indications than a prior BEAMAX (K063249) but is similar to the broader IPL indications of Harmony XL™ (K072564) and Cutera (K050047). No new questions of safety or effectiveness are raised. |
| Technological Features | Similar technology, performance, and specifications to legally marketed predicate devices. | The device is a pulsed light energy device based on a filtered Xenon flashlamp, similar to the predicate devices. It operates with a total emission spectrum of 300 nm to 1000 nm, and uses longpass optical filters to block specific wavelengths. Specific handpieces cater to different applications, similar to predicate devices. |
| Risks and Benefits | Comparable to predicate devices. | Due to similarity in intended use, indications, and technological features, the risks and benefits are comparable to the predicate devices. |
| Safety & Effectiveness | No new questions of safety or effectiveness are raised. | The submission states that "there are no new questions of safety or effectiveness raised by the introduction of SharpLight's BEAMAX/FORMAX Fluorescent Pulsed Light Systems." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, as direct human clinical outcome data from a "test set" for the new device is not provided. The "test" here is the comparison against the characteristics and established safety/effectiveness of predicate devices already on the market.
- Data Provenance: The "data" for comparison comes from the regulatory filings and established performance of the identified predicate devices, which are already marketed in the US. There is no mention of country of origin for new clinical data, nor is there a distinction between retrospective or prospective data for a newly conducted study for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the context of a 510(k) for substantial equivalence, is established by the FDA's prior clearance of the predicate devices based on their safety and effectiveness. No new expert consensus panel was convened for this specific submission to establish a "ground truth" for a new test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since there's no new test set with human subject data requiring expert review and adjudication for this submission, no adjudication method like 2+1 or 3+1 was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on technological and indications-for-use equivalence rather than human reader performance with or without AI assistance. The device is a pulsed light system, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is an energy-based medical device (pulsed light system), not an algorithm or AI system. Its performance is inherent in its physical operation and energy delivery for therapeutic purposes.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics, intended use, and indications are compared against these established "truths" to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for such a set.
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(104 days)
The Juniper Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort.
The Juniper Cooling Device a thermoelectric cooling device that applies controlled cooling to a treatment site.
The provided text describes a 510(k) summary for the Juniper Cooling Device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a scientific or clinical study.
Instead, the submission establishes substantial equivalence to predicate devices based on:
- Intended Use: The indications for use are the same as predicate devices.
- Technological Comparison: The device is described as a thermoelectric cooling device, similar to the predicates.
- Bench Testing: "Bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices."
Therefore, most of the requested information regarding detailed acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document primarily focuses on demonstrating substantial equivalence to already marketed devices.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices | "Bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices." |
| Indications for Use Match Predicate Devices | "The indications for use for the Juniper Cooling Device are the same as predicate devices cited in this application." |
Note: No specific numerical or quantitative acceptance criteria (e.g., cooling temperature range, cooling rate, pain reduction percentage) are provided in this summary. The "performance data" section is very general.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The submission refers to "bench testing" but does not detail the sample size, specifics of the "test set" (e.g., number of devices tested, number of simulated skin models), or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission focused on substantial equivalence where detailed clinical trial data might not be required if technological equivalence and intended use are sufficient.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. There is no mention of human experts establishing ground truth for any test data in this submission. The evaluation is based on technical comparison and bench testing for functional equivalence.
4. Adjudication method for the test set
Not applicable/Not provided. No adjudication method is described, as there isn't a human expert-based ground truth establishment process detailed.
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 a cooling device, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human reader performance or AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The device is a physical cooling device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant. The "performance data" refers to the device's functional equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. The evaluation appears to be based on the device's functional characteristics observed during "bench testing" compared to predicate devices, rather than a "ground truth" derived from clinical outcomes, pathology, or expert consensus on patient data.
8. The sample size for the training set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable/Not provided. As it's not an AI/ML algorithm, there is no training set or associated ground truth.
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(142 days)
The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I-VI, and mild to moderate psoriasis in patients with Fitzpatrich skin types I-VI.
The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for the treatment of psoriasis in patients with Fitzpatrick skin types I - VI.
The provided text is a 510(k) Summary for the Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis Treatment. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain a study or data proving the device meets specific acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.
The document primarily focuses on demonstrating substantial equivalence to already cleared devices, a regulatory pathway that doesn't necessarily require new clinical studies with defined acceptance criteria to be submitted or summarized in the 510(k) application itself. The statement "The new psoriasis indication for use is based upon the indications for use for two already cleared predicate pulsed light device Systems" further supports this, suggesting reliance on prior approvals rather than new performance data for this specific 510(k).
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