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The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).

The DEPILASE TRIO LASE Laser System is based on Nd: YAG and Alexandrite Jaser technology. Within the same system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.

The DEPILASE TRIO LASE Laser System is designed with 6 major sub-systems:

• a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
• b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
• c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
• d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
• e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
• The microprocessor based controller which regulates the functions of the laser and allows f) parameter selection by the user.

The provided document is a 510(k) summary for the DEPILASE TRIO LASE Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving those criteria were met for a new AI/medical device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, and AI-specific metrics (like MRMC studies or standalone performance) is not present in this type of regulatory submission.

The document asserts substantial equivalence based on intended use and technological characteristics compared to previously cleared devices, implying that if the new device functions similarly and has comparable risks and benefits, then its performance is implicitly acceptable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics for the DEPILASE TRIO LASE Laser System itself. The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices for specific clinical applications.
• Reported Device Performance: The document states that the DEPILASE TRIO LASE Laser System's "output characteristics are very similar to those of the predicate devices." This is the primary "performance" reported in the context of substantial equivalence. No specific numerical performance results (e.g., success rates for hair removal, lesion coagulation effectiveness percentages) for the DEPILASE TRIO LASE are provided.

2. Sample Size for Test Set and Data Provenance:

• The document does not describe a clinical study or test set for the DEPILASE TRIO LASE Laser System to prove its performance against specific acceptance criteria.
• Instead, it refers to the established performance of predicate devices.
• Therefore, there is no information on a sample size, country of origin, or whether it was retrospective or prospective test data for the Depilase device itself.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. The document does not describe a study involving expert-established ground truth for the DEPILASE TRIO LASE Laser System. The "ground truth" for clearance is the regulatory precedent set by the predicate devices.

4. Adjudication Method:

• Not applicable. No ground truth establishment process for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an AI-enabled device requiring an MRMC study. The document describes a physical laser system.

6. Standalone Performance Study:

• No. The document's purpose is to demonstrate substantial equivalence to existing devices, not to present a standalone performance study with detailed metrics for the new device. Performance is inferred from equivalence.

7. Type of Ground Truth Used:

• The "ground truth" for the clearance of this device is essentially the regulatory acceptance and clinical history of the predicate devices mentioned (Laserscope Lyra, Altus Medical Aesthetic CoolGlide, Fotona Dualis KTP, Candela GenteLASE GL, GenteLASE II, Cynosure Apogee TSK). These predicate devices would have undergone their own studies and received clearance based on demonstrating efficacy and safety for their respective indications, which then serve as the benchmark for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."

9. How Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

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The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and the dermatological use for the non invasive treatment of facial wrinkles (1064 nm wavelength).

The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by passing with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided text is a 510(k) summary for the DEPILASE TWIN YAG Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than describing a performance study with specific acceptance criteria and detailed results.

Therefore, most of the information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

• Not present. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics from a study. It asserts "The DEPILASE TWIN YAG Laser System output characteristics are very similar to those of the predicate device" but provides no data.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not present. No test set or clinical study data is described. The submission relies on substantial equivalence to a previously cleared device.

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 present. No ground truth establishment for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not present. No adjudication method is described because no test set or clinical study is 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. This device is a laser system for dermatological applications, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies. No such study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a laser device, not an algorithm. Standalone performance is not relevant in the context of this device type as it's not an AI/software-as-a-medical-device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not present. No ground truth is described because no clinical performance study is detailed.

8. The sample size for the training set

• Not applicable/Present (indirectly). This device is a physical laser system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for this device would refer to its design, engineering, and manufacturing process based on established laser technology. The comparison focuses on the predicate device, the Laserscope Lyra (K020021), which serves as the benchmark for equivalence.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set for an AI algorithm is involved.

Summary of Device and Equivalence Claim (from the document):

The DEPILASE TWIN YAG Laser System is an Nd:YAG laser system for dermatological applications.

Intended Use: Non-invasive treatment of facial wrinkles (1064 nm laser emission). Other indications mentioned in Appendix F include: coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), and removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI.

Substantial Equivalence Claim: The device is claimed to be substantially equivalent to the Laserscope Lyra (K020021) Nd:YAG laser for the non-invasive treatment of facial wrinkles.

Basis for Equivalence:

• Identical intended use for facial wrinkles.
• Technologically identical characteristics: flashlamp pumped Nd:YAG laser rod generating 1064 nm light, delivered via optical fiber and focusing handpiece.
• "Very similar" output characteristics to the predicate device.
• Both are microprocessor-controlled.
• Both use Class I aiming beams.
• Both use internal closed-loop water-air heat exchange for thermal control.
• Risk and benefits are comparable to the predicate device for similar applications.

The document does not detail a study conducted with the DEPILASE TWIN YAG Laser System to prove it meets specific acceptance criteria. Instead, it argues that its device is equivalent to a legally marketed predicate device, relying on the predicate's prior clearance and established safety and effectiveness.

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The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial wrinkles.

The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal. which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided document is a 510(k) summary for the DEPILASE YAG LASE PLUS Laser System. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about a study to prove adherence to specific performance acceptance criteria for the treatment of facial wrinkles.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, or study methodologies because this information is not present in the document.

The document states:

• Intended Use: The DEPILASE YAG LASE PLUS Laser System is indicated for the use in dermatological applications for the treatment of facial wrinkles.
• Substantial Equivalence: Depilase believes its device is substantially equivalent to the Laserscope Lyra (K020021) Nd: YAG laser, previously cleared for the use in dermatological applications for the treatment of facial wrinkles.

This 510(k) summary relies on demonstrating that the new device has similar technological characteristics, intended use, and comparable risks and benefits to a previously cleared device. It does not describe a new clinical study with specific acceptance criteria to evaluate the effectiveness of the DEPILASE YAG LASE PLUS Laser System for facial wrinkle treatment.

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The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions( 1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).

The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by warelonging with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using (SHO). The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:

• a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
• b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
• c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
• d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
• e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

Here's an analysis of the provided text regarding the Depilase Twin YAG Laser System, focusing on the acceptance criteria and study information.

It's important to note that the provided 510(k) summary is for a laser system, not an AI/ML powered device. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample sizes for test and training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable and will be marked as such. The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

Acceptance Criteria and Study Information for Depilase Twin YAG Laser System (K020697)

1. Table of Acceptance Criteria and Reported Device Performance

1. Coagulation and haemostasis of vascular lesions (1064 nm and 532 nm wavelengths).
2. Removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength).
   These indications are stated to be the same as those of the predicate devices: Laserscope Lyra (K990718) and Altus Medical Aesthetic CoolGlide (K991798) for hair removal/vascular lesions (Nd:YAG), and Fotona Dualis KTP (K011939) for vascular lesions (532 nm). |
   | Technological Equivalence | The device's technological characteristics must be identical or very similar to those of legally marketed predicate devices, and any differences should not raise new questions of safety or effectiveness. | Met: The DEPILASE TWIN YAG Laser System, like the predicate devices, comprises:

• Flashlamp-pumped Nd:YAG laser rod generating light at 1064nm (with optional 532nm via SHC).
• Optical fiber delivery system and focusing handpiece.
• Microprocessor controlled.
• Class I aiming beams.
• Internal closed-loop water-air heat exchange for thermal control.
  The output characteristics are reported as "very similar" to predicate devices. |
  | Safety and Effectiveness | The risks and benefits of the device, when used for its intended applications, must be comparable to those of the predicate devices, and the device should not raise new questions of safety or effectiveness. | Met: The submission asserts that "The risk and benefits of the DEPILASE TWIN YAG Laser System are comparable to the predicate devices when used for similar clinical applications." Concludes: "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device." This is indirectly evidenced by the FDA's clearance of the device based on substantial equivalence. |

2. Sample Size for the Test Set and Data Provenance

• Not Applicable (N/A) for AI/ML device: This is a laser system, not an AI/ML device. Therefore, there isn't a "test set" in the context of evaluating algorithm performance on a dataset of images or other data types. The submission relies on demonstrating engineering and clinical equivalence to existing predicate devices.

3. Number of Experts and Qualifications for Ground Truth

• N/A for AI/ML device: Ground truth for AI/ML performance evaluation is not relevant for this type of laser system submission. The "ground truth" implicitly assessed here is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• N/A for AI/ML device: No test set or adjudication method as would be used for AI/ML algorithm performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study performed: As this is a laser system, an MRMC study comparing human readers with and without AI assistance is not applicable. The device's effectiveness is established through clinical equivalence to predicate devices, not by assisting human interpretation of data.

6. Standalone (Algorithm Only) Performance Study

• No Standalone Study Performed: Not an AI/ML device. The "standalone" performance for this laser system would refer to its physical output and functional specifications, which were likely tested during development and manufacturing, but not in a formal "standalone performance study" akin to an AI algorithm.

7. Type of Ground Truth Used

• Clinical Equivalence/Predicate Devices' Established Safety and Effectiveness: For this type of device, the "ground truth" essentially comes from the established safety and effectiveness records and clinical use history of the identified predicate devices (Laserscope Lyra, Altus Medical Aesthetic CoolGlide, Fotona Dualis KTP). The applicant is arguing that their device operates similarly and achieves comparable outcomes, thus leveraging the "ground truth" already established for the predicates.

8. Sample Size for the Training Set

• N/A for AI/ML device: There is no "training set" as would be used for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

• N/A for AI/ML device: No training set, therefore no associated ground truth establishment method.

Summary of the Study (Substantial Equivalence Argument):

The "study" presented in this 510(k) is a demonstration of substantial equivalence (not a randomized controlled trial or an AI performance study). The applicant, Depilase Group Ltd., systematically compares their DEPILASE TWIN YAG Laser System against three predicate devices already cleared by the FDA:

• Laserscope Lyra (K990718)
• Altus Medical Aesthetic CoolGlide (K991798)
• Fotona Dualis KTP (K011939)

The core of their argument is that their device shares identical intended use (coagulation/haemostasis of vascular lesions, permanent hair reduction) and substantially similar technological characteristics (Nd:YAG laser with optional 532nm, fiber optic delivery, microprocessor control, aiming beam, cooling system) with these predicates. They also assert that the device's output characteristics are "very similar" to the predicates. By demonstrating these similarities, the applicant aims to convince the FDA that their device raises no new questions of safety or effectiveness beyond what has already been established for the predicate devices. The FDA's clearance indicates their concurrence with this argument.

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The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types.

The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided text is a 510(k) Summary for the DEPILASE YAG LASE PLUS Laser System. This document focuses on establishing substantial equivalence to previously cleared devices rather than on presenting results from clinical trials with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fulfilled from the provided text. The document describes the device, its intended use, and argues for its substantial equivalence to predicate devices (Laserscope Lyra K990718 and Altus Medical Aesthetic CoolGlide K991798). It does not contain information about new studies conducted to prove the performance of the DEPILASE YAG LASE PLUS Laser System against specific acceptance criteria.

Here's an attempt to address the request based only on the provided information, noting where information is absent:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/not provided. The submission is based on substantial equivalence to predicate devices, not on a new clinical study with a test set of patients.
• Data Provenance: Not applicable/not provided for a new clinical study. The "data" referenced relates to the established safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/not provided. No new test set data requiring expert-established ground truth is presented in this 510(k) summary.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/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

• MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic or imaging device used by human readers in the context of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Study: Not applicable. This is a medical device (laser system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable for this device's submission in the provided text. The submission relies on the established safety and effectiveness track record (implied outcomes data, clinical experience, and regulatory clearance) of the predicate devices.

8. The sample size for the training set

• Sample Size: Not applicable/not provided. This document does not describe the development or training of an algorithm.

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not applicable/not provided.

Summary of what the document does provide regarding its "proof":

The "study" in this context is a substantial equivalence argument to predicate devices cleared by the FDA. The proof is based on demonstrating:

• Identical Intended Use: The DEPILASE YAG LASE PLUS Laser System has the same indications for use as the predicate devices (coagulation and haemostasis of vascular lesions, and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin).
• Similar Technological Characteristics: All utilize flashlamp pumped Nd:YAG laser rods, generating light at 1064nm, delivered via optical fiber and focusing handpiece, microprocessor controlled, use Class I aiming beams, and internal closed-loop water-air heat exchange for cooling.
• Comparable Performance (Implied): The output characteristics are "very similar" to predicate devices, and risks and benefits are comparable.

Therefore, the "proof" is a regulatory argument for equivalence rather than a detailed report of a new clinical investigation with quantifiable acceptance criteria.

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The DEPILASE TWIN LASE Laser System is indicated for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.

The DEPILASE TWIN LASE Laser System is based on Nd: YAG and Alexandrite laser technology. Within the system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.

The DEPILASE TWIN LASE Laser System is designed with 6 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
f) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided text is a 510(k) summary for the DEPILASE TWIN LASE Laser System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a de novo study with specific acceptance criteria and performance metrics for a completely new device.

Therefore, the requested information regarding acceptance criteria, device performance, study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in the provided text.

The core of this 510(k) submission is to show that the DEPILASE TWIN LASE Laser System has the same intended use and similar technological characteristics to predicate devices. The document directly states: "The risk and benefits of the DEPILASE TWIN LASE Laser System are comparable to the predicate devices when used for similar clinical applications. It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device."

To address the prompt as much as possible, here's what can be inferred or stated from the text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: The implied acceptance criteria for this 510(k) is "substantial equivalence" to previously cleared predicate devices for the stated intended uses. This means the device should possess similar technological characteristics, safety profiles, and effectiveness as the predicate devices. Specific quantitative performance metrics (e.g., success rates, complication rates) are not provided for the DEPILASE TWIN LASE system itself, but rather inferred to be "comparable" to the predicates.
   • Reported Device Performance: No specific quantitative performance data (e.g., success rates, adverse event rates from a study) are reported for the DEPILASE TWIN LASE Laser System in this document. The submission relies on the established performance and safety of the predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. The document does not describe a new clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication 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. This device is a laser system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system; the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no new clinical study data presented requiring ground truth. The "ground truth" for the submission is the regulatory clearance and established safety/effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. No training set for a new algorithm or device development is mentioned.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text asserts substantial equivalence by comparing the DEPILASE TWIN LASE Laser System's intended use and technological characteristics to several already-cleared predicate lasers. It does not contain information about a specific study design with acceptance criteria, sample sizes, or ground truth establishment for a new clinical performance study of the device itself.

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