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JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

The JOULE 1927nm Laser System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

The Sciton, Inc. JOULE 1927nm Laser System is a laser surgical instrument intended for dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions. The device received 510(k) clearance (K182173) on March 6, 2019, based on demonstrating substantial equivalence to predicate devices, namely the Solta FraxelDUAL (K130193) and the Lutronic LASEMD Laser System (K171009).

This device did not undergo a study to prove it met specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, its acceptance was based on non-clinical performance data and a comparison of its technological characteristics and indications for use to legally marketed predicate devices.

Here's the breakdown of the information provided in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not presented as a table of acceptance criteria for clinical performance in the provided document. The device's acceptance was based on demonstrating substantial equivalence to predicate devices in terms of its technological characteristics, intended use, and safety. The provided table (on page 4) lists the specifications of the JOULE 1927nm Laser System and its predicate devices, indicating where they are substantially equivalent.

   Specification	Predicate Device (FraxelDUAL)	Predicate Device (LASEMD Laser System)	This Application (JOULE 1927nm)	Substantially Equivalent
   Indications for Use	Same as JOULE	Same as JOULE	Dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions.	Yes
   CDRH Laser Class	Class 4	Class 4	Class 4	Yes
   Laser Type	Thulium Laser	Thulium Laser	Thulium Laser	Yes
   Energy Source	1927 nm	1927 nm	1927 nm	Yes
   Spot Size	256 – 620 µm	100 - 200 µm	100 – 620 µm	Yes
   Maximum Tip Width	7 and 15 mm	10 mm	15 mm	Yes
   Wavelength	1927 nm	1927 nm	1927 nm	Yes
   Pulse Repetition Rate	0 – 3 kHz	43.5 - 307.7 Hz	0 – 3 kHz	Yes
   Pulse Duration	Up to 10 ms	Up to 20 ms	Up to 20 ms	Yes
   Energy	Up to 20 mJ	Up to 20 mJ	Up to 20 mJ	Yes
   Utilities	120-240 VAC, 50/60 Hz	100-240 VAC, 50/60 Hz	200-240 VAC/25A, 50/60 Hz	Yes
   Power	12 W (1927 nm)	5 W (1927 nm)	12 W (1927 nm)	Yes
   Aiming Beam	Red	Red	Red	Yes
   Delivery System	Fiber optic	Fiber and Handpiece	Articulated Arm or Fiber optic	Yes
   Emission Control	Footswitch	Footswitch	Footswitch	Yes
   Display Screen	Yes	Yes	Yes	Yes
   Cooling System	Air to Air	Air to Air	Water to Air	Yes

(Functionally Equivalent) |
| Control System | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy Monitor | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Yes |
| Safety | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Safety Eyewear and Remote Interlock Connector | Yes |

2. Sample size used for the test set and the data provenance: Not applicable. The FDA clearance was based on non-clinical performance data and substantial equivalence arguments, not on a clinical test set with patient data for assessing diagnostic or treatment efficacy in the same way an AI device might be. The non-clinical tests relate to device safety and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set for which ground truth needed to be established by experts for performance evaluation.

4. Adjudication method for the test set: Not applicable.

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 treatment, not an AI-assisted diagnostic device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device, a laser system, not an algorithm.

7. The type of ground truth used: For the non-clinical performance data, the "ground truth" would be established by validated test methods and engineering specifications. For example, for electrical safety, the ground truth is adherence to standards like IEC 60601-1. For biocompatibility, the ground truth is determined by testing against ISO 10993-1. These are objective measures against established standards.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.

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

Summary of the "Study" and Acceptance Criteria:

The "study" in this context refers to the non-clinical performance testing and the comparative analysis against predicate devices to demonstrate substantial equivalence.

• Acceptance Criteria: The primary acceptance criterion was demonstrating substantial equivalence to the legally marketed predicate devices (Solta FraxelDUAL K130193 and Lutronic LASEMD Laser System K171009) in terms of:

  • Intended Use: The JOULE 1927nm Laser System shares the same Indications for Use as the predicates (dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions).
  • Technological Characteristics: The device shares similar design features (wavelength, laser medium and delivery systems, power supply, cooling and control system) and functional features (power output, repetition rate, energy, spot size, and fluence). Minor differences in cooling system (Water to Air vs. Air to Air) and physical dimensions were deemed not to raise new questions of safety or effectiveness.
  • Safety Standards: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
  • Software Verification and Validation: Successful performance of software V&V.
  • Biocompatibility: Patient-contacting components were tested for biocompatibility per ISO 10993-1.

• Device Performance:

  • Non-Clinical Performance Data: Electrical safety, electromagnetic compatibility, software verification and validation, and biocompatibility testing were all "successfully performed" according to the relevant standards.
  • Comparative Performance: The JOULE 1927nm Laser System's specifications (e.g., energy, pulse repetition rate, spot size, wavelength) fall within the range or are comparable to those of the predicate devices, supporting the claim of substantial equivalence for its intended use.

In conclusion, the FDA clearance for the JOULE 1927nm Laser System was based on non-clinical engineering and safety tests, and a direct comparison of its technical specifications and indications for use against already-cleared predicate devices, rather than a clinical study evaluating its direct performance against a ground truth from a patient-based test set or an AI algorithm's performance.

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The Joule 2940 nm ProFractional System with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dernatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi: Telangiectasia: Spider veins: Actinic chelitis: Keloids: Verrucae: Skin tags: Keratoses: Scar revision (including acne scars).

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

This document is a 510(k) premarket notification for the Sciton, Inc. JOULE ProFractional System. It demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or presenting a new clinical study for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device is not explicitly present in the provided text.

The document primarily focuses on demonstrating that the JOULE ProFractional System is substantially equivalent to existing devices based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what is not available based on your request:

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

This document does not present specific acceptance criteria for this new device's performance in a clinical study, nor does it report new device performance data against such criteria. Instead, it compares the technical specifications and intended uses of the JOULE ProFractional System to those of predicate devices to demonstrate substantial equivalence. The table on page 4 provides a comparison of specifications:

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. This is a 510(k) submission based on substantial equivalence, not a clinical study with a test set. There is no mention of a specific test set, data provenance, or data type (retrospective/prospective) for a clinical performance evaluation of the JOULE ProFractional System.

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. No ground truth establishment for a test set is discussed in this document.

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

Not applicable. No adjudication method for a test set is discussed.

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. An MRMC study is beyond the scope of this type of 510(k) submission. There is no mention of AI assistance or human reader improvement.

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

Not applicable. This device is a laser surgical instrument, not an algorithm. Therefore, standalone performance in the context of an algorithm is not relevant.

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

Not applicable. No clinical ground truth is established for this submission. The "ground truth" for this 510(k) is the established performance and safety of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and therefore does not have a training set in that context.

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

Not applicable, for the same reason as point 8.

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The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

The provided text is a 510(k) Summary for the Sciton JOULE ProFractional System. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain acceptance criteria or details of a study proving the device meets specific performance criteria in the way a clinical trial report would.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics and indications for use of the JOULE ProFractional System to those of several predicate devices already on the market.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on your request and the limitations of the provided document:

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

This information is not available in the provided 510(k) summary. The document focuses on demonstrating "substantial equivalence" to predicate devices, not on meeting specific, quantitative acceptance criteria for performance as would be seen in a clinical study report. The table presents a comparison of technical specifications between the proposed device and predicate devices.

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

This information is not available in the provided 510(k) summary. The document does not describe a clinical test set or study data in this manner.

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)

This information is not available in the provided 510(k) summary. The document does not describe a process for establishing ground truth using experts.

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

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary. This device is a laser surgical instrument, and the document does not mention AI assistance or MRMC studies.

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

This information is not available in the provided 510(k) summary. This is a medical device, not an AI algorithm, and thus standalone performance for an algorithm is not applicable.

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

This information is not available in the provided 510(k) summary.

8. The sample size for the training set

This information is not available in the provided 510(k) summary as it is not an AI/algorithm-based device and does not refer to a "training set."

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

This information is not available in the provided 510(k) summary for the reasons mentioned above.

Summary of what the document DOES provide regarding comparison:

The document relies on demonstrating "substantial equivalence" to predicate devices (K101916, K081352, K100270, K110907, K142376) rather than defining and meeting specific, quantitative acceptance criteria via a new study.

The comparison table on page 4 (labeled "5") shows how the JOULE 2940 Fractional Handpiece (This Application) aligns with or is comparable to predicate devices across various technical specifications:

• Indications for Use: "Yes" - indicates substantial equivalence to all listed predicates.
• Ref. 510(k): K173285 for "This Application."
• Energy Source: 2940 nm Er:YAG for all, "Yes" for substantial equivalence.
• Spot Size: Range from 1.3x1.3mm to 20x20mm for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Wavelength: 2940 nm for all, "Yes" for substantial equivalence.
• Maximum Repetition Rate: Up to 3 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Pulse Duration: 0.5 to 1.5 msec for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Energy: Up to 70 mJ/microbeam for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Utilities: 230 VAC/25A, 50/60 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Aiming Beam: Red/Green for new device and some predicates. "Yes" for substantial equivalence.
• Delivery System: Articulated Arm for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Cooling System: Water to Air for all, "Yes" for substantial equivalence.
• Control System: Microprocessor for all, "Yes" for substantial equivalence.
• Energy Monitor: "Display Indicates Energy Delivered to Tissue" for all, "Yes" for substantial equivalence.
• Safety: Safety Eyewear and Remote Interlock Connector for the new device and some predicates. "Yes" for substantial equivalence.
• Console Dimensions: 14" x 21" x 41" high for the new device, comparable to some predicates. "Yes" for substantial equivalence.
• Weight: 200 lbs for the new device, comparable to some predicates. "==" (presumably "Yes") for substantial equivalence.

The study that proves device meets acceptance criteria, in this context of a 510(k), is the comparison to legally marketed predicate devices, demonstrating that its technological characteristics and intended use are sufficiently similar. The "proof" is the argument of substantial equivalence, not data from a new clinical study with specific acceptance criteria.

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