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510(k) Data Aggregation
(29 days)
The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar laser system is intended for the treatment of benign vascular lesions.
The MeDioStar laser system is intended for the treatment of benign pigmented lesions.
The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months ..
The modified MeDioStar is a pulsed diode laser emitting a wavelength of 755 - 1060 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
The provided text describes modifications to an existing laser system, the "MeDioStar," focusing on an expanded wavelength range. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics for its stated indications for use (e.g., hair reduction, treatment of vascular/pigmented lesions).
The document primarily focuses on:
- Regulatory Clearance (510(k) summary): Confirming that the modified device is substantially equivalent to a predicate device.
- Device Description: Outlining the technical specifications and modifications from the previous version.
- Performance Standards (Non-clinical): Listing the electrical safety, electromagnetic compatibility, software, usability, risk management, and laser-specific safety standards that the device passed. These standards ensure the device is safe and functions correctly from an engineering perspective, but not necessarily its clinical efficacy for its stated indications.
Therefore, for your specific request, most of the information is not present in the provided document. I can only report on what is available.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance standards the device passed, which are primarily related to safety and engineering aspects, not clinical efficacy or specific acceptance criteria for its intended uses (hair reduction, lesion treatment). Therefore, a table for clinical performance criteria and results cannot be generated from this text.
The document states:
- "MeDioStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."
The performance standards mentioned are:
- ISO 60601-1: Medical electrical equipment Part 1: General requirements for safety and essential performance
- ISO 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 62304: Medical Device Software – Software life cycle processes
- IEC 62366-1: Medical devices Application of usability engineering to medical devices
- IEC 60601-2-22: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
- ISO 14971: Medical devices – Application of risk management to medical devices
- Software verification and validation testing (according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document does not describe any clinical test sets or studies related to the device's efficacy for its intended uses.
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 provided. There is no mention of clinical experts or ground truth establishment for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided.
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 provided. This is a laser device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not provided. This is a laser device, not an AI algorithm performing a standalone task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided. No clinical ground truth is discussed.
8. The sample size for the training set
Not provided. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not provided. No training set or ground truth for it is mentioned.
In summary: The provided FDA 510(k) clearance letter and summary primarily address the safety and engineering compliance of a modified medical laser device (MeDioStar) compared to its predicate. It confirms that the device meets various international and FDA standards for electrical safety, software, usability, and risk management. However, it does not include information about clinical performance studies, efficacy acceptance criteria, or any data related to how well the device performs for its stated indications (e.g., hair reduction, treatment of lesions). Such clinical data, if required for a 510(k), would typically be referenced or summarized, but none appears in this document.
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(185 days)
The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and in dermatology.
The MeDioStar laser system is intended for the treatment of benign vascular lesions.
The MeDioStar laser system is intended for the treatment of benign pigmented lesions.
The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
The MeDioStar is a pulsed diode laser emitting a wavelength of 750 - 950 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
This document is a 510(k) Pre-Market Notification for a medical device, specifically a laser system. It outlines the modifications to an existing device, the MeDioStar, and demonstrates its substantial equivalence to previously cleared predicate devices.
Based on the provided document, there is no information regarding acceptance criteria, reported device performance metrics against those criteria, or clinical study details (sample size, data provenance, expert adjudication, MRMC, standalone algorithm performance, ground truth establishment for test or training sets).
The document explicitly states: "Clinical Performance Data: None".
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through:
- Technical Modifications: Listing specific changes from the predicate device (e.g., GUI design, handpiece port, repetition rate, handpieces, USB drive).
- Comparison of Technical Characteristics: A table comparing the subject device (MeDioStar) to its main predicate (MeDioStar NeXT Family) and two reference predicates (Primelase Excellence, LightSheer Infinity/Duet/Desire) across various parameters like laser source, wavelength, pulse duration, fluence, repetition rate, intended use, and handpiece ports.
- Non-clinical Performance Data: Listing standards to which the device complies (e.g., ISO 60601-1, IEC 62304, ISO 14971) and stating that software verification and validation testing were conducted successfully.
The FDA 510(k) process for this device type often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring new clinical studies and performance benchmarks against specific acceptance criteria. This is particularly true for modifications to existing cleared devices, as is the case here ("Special 510(k)").
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(9 days)
The MeDioStar NeXT laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT laser system is intended for the treatment of vascular lesions.
The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.
The MeDioStar NeXT is a pulsed diode laser emitting a wavelength of 800 - 950 nm, that is operated with a handpiece in contact with the skin
This 510(k) submission for the Asclepion Laser Technologies GmbH MeDioStar NeXT does not include specific acceptance criteria or a study demonstrating that the device meets such criteria.
The submission states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Instead, the device is deemed substantially equivalent to predicate devices (LightSheer Duet K053628 and MeDioStar XT K050900) based on similar principles of operation, parameters, and indications for use. The conclusion is that "The MeDioStar NeXT is another safe and effective device for the treatment of vascular lesions, for hair removal, permanent hair reduction and the treatment of pigmented lesions" primarily due to its similarity to already approved devices, rather than new performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is explicitly stated as "None" in the provided document.
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(35 days)
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.
MeDioStar XT Laser System is a pulsed diode laser with a wavelength of 808µm. It consists a laser enclosure and optic delivery system (fiber bundle and handpiece).
The provided text is a 510(k) summary for the Asclepion Laser Technologies GmbH MeDioStar XT Laser System. It is a premarket notification to the FDA for a new medical device, aiming to demonstrate substantial equivalence to a predicate device. This type of document does not typically contain detailed acceptance criteria or a study proving that the device meets specific performance metrics in the way a clinical trial report would.
Here's an analysis based on the provided text, highlighting what's missing and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to MeDioStar H Laser System | Claimed substantial equivalence |
| Same principles of operation as predicate | Same principles of operation confirmed |
| Same wavelength as predicate | Same wavelength (808µm) confirmed |
| Essentially the same power range as predicate | Essentially the same power range confirmed |
| Safety and effectiveness for unwanted body hair removal | Deemed safe and effective (by FDA K050900 letter) |
| Safety and effectiveness for vascular lesion treatment | Deemed safe and effective (by FDA K050900 letter) |
Explanation:
The document does not state explicit, quantitative acceptance criteria for performance parameters such as hair reduction percentage, number of treatments, or lesion clearance rates. Instead, the "acceptance criteria" here are implied by the 510(k) process, which focuses on demonstrating substantial equivalence to a predicate device. The performance is "reported" by stating that the device is substantially equivalent and therefore safe and effective for its stated indications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no new test set of data (clinical or nonclinical) was generated or used for this 510(k) submission to demonstrate performance a new.
- Data Provenance: Not applicable, as no new data was submitted or analyzed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Since no new clinical or non-clinical performance data was generated or analyzed for this submission, there was no need for experts to establish ground truth from such data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As no test set data was provided, no adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: None."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, this device is a physical laser system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant or mentioned.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for performance data related to the MeDioStar XT itself. The "ground truth" for the 510(k) submission relies on the established safety and effectiveness of the predicate device (MeDioStar H Laser System). The new device is claimed to be safe and effective because it is substantially equivalent to the predicate, not based on new, direct evidence from the MeDioStar XT itself.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This document does not describe the development or training of an algorithm, but rather the regulatory submission for a physical laser device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No algorithm training set is mentioned or relevant to this type of device submission.
In Summary:
The provided 510(k) summary is for a device seeking market clearance based on substantial equivalence to an already approved predicate device. For such submissions, detailed performance studies with acceptance criteria and clinical data are often not required if the new device can demonstrate very close similarity in design, function, and intended use to an existing device. The FDA's acceptance of this 510(k) indicates their agreement that the MeDioStar XT Laser System is substantially equivalent to the MeDioStar H Laser System and is therefore safe and effective for its intended uses without new clinical data.
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