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The Q-Plus T + IPL Laser System is intended for the incision, ablation and vaporization of soft tissue for general dermatology. The device includes a Q-Switched Nd:YAG laser source with a max energy of 1000mJ at 1064nm and a max energy of 500mJ at 532nm, a Q-Switched Ruby laser source with a max energy of 1000mJ at 694nm, and an intense pulse light (IPL) hand piece. The Q-Switched lasers are intended for treatment of pigmented lesions and tattoo removal. The optical delivery system for the three laser wavelengths is an articulated arm with replaceable hand pieces with 2, 3, 4, and 6 mm spot sizes. The IPL hand piece, depending on the particular wavelength filter used, is intended for hair removal, treatment of dermatological vascular lesions, benign pigmented lesions and inflammatory acne (acne vulgaris). The IPL hand pieces are provided in a fixed or a replaceable configuration. The Q-Plus T + IPL laser system incorporates several safety features, including a remote interlock, a key switch and an emergency stop button.

The Quanta System SPA Q-Plus T + IPL Laser System is a laser surgical instrument designed for use in general and plastic surgery and in dermatology. It's intended for the incision, ablation, and vaporization of soft tissue, as well as for the treatment of vascular and pigmented lesions, tattoo removal, and inflammatory acne (acne vulgaris).

The device's performance is demonstrated through substantial equivalence to two predicate devices: K073549 Q-Plus T and K083207 Ultrawave III EX 1320. The submission states that "The Quanta System Q-Plus T + IPL laser system is as safe and effective as the predicate devices. The Q-Plus T + IPL laser system has the same intended use and similar technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Q-Plus T + IPL laser system and its predicate devices raise no new issues of substantial equivalence or safety and effectiveness."

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission based on technological characteristics and intended use, formal "acceptance criteria" with specific performance metrics (like sensitivity, specificity, or accuracy) derived from a clinical study are not provided in the document. Instead, the "acceptance criteria" can be inferred as demonstrating that the technological characteristics and indications for use of the Q-Plus T + IPL Laser System are substantially equivalent to the cleared predicate devices.

Study that Proves the Device Meets Acceptance Criteria:

The current submission for the Q-Plus T + IPL Laser System does not provide details of specific clinical or performance studies with acceptance criteria in the traditional sense (e.g., sensitivity, specificity, or controlled patient trials). Instead, the "study" proving the device meets the acceptance criteria is a benchmarking and comparison study against two legally marketed and cleared predicate devices (K073549 Q-Plus T and K083207 Ultrawave III EX 1320).

The argument for substantial equivalence is based on:

• Identical/Similar Technological Characteristics: The laser sources (Q-Switched Nd:YAG and Ruby) are identical to the Q-Plus T. The IPL hand piece is the same as the IPL hand piece of the Ultrawave III EX 1320. Other components are similar or identical.
• Equivalent Intended Use: The intended uses align with the combined indications of the predicate devices.

This means the "study" is effectively a literature review and technical comparison of the device's specifications and indications for use against those of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. The submission relies on technical comparison and the established safety and effectiveness of the predicate devices. There is no mention of a separate "test set" of patients or data for this specific submission to prove clinical efficacy.
• Data Provenance: Not applicable for a new clinical test set. The provenance relies on the regulatory clearances and underlying data (which are not detailed here) for the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. No new test set requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. No new test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is not mentioned or required for this 510(k) submission, which focuses on substantial equivalence to existing devices based on technological characteristics and intended use.

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

• Not applicable. This device is a laser system, not an algorithm, and its performance inherently involves human operation.

7. The Type of Ground Truth Used:

• Indirect Ground Truth: The "ground truth" for the Q-Plus T + IPL Laser System is established indirectly through the proven safety and efficacy of the predicate devices for their respective indications. The FDA's clearance of the predicate devices implies that sufficient evidence (including, for example, clinical data, performance testing, and expert consensus from those prior submissions) was provided to support their safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. As this is not an AI/algorithm device that requires a training set. The submission is based on demonstrating substantial equivalence to pre-existing, cleared devices.

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

• Not applicable.

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Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Ruby (694nm)
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are

• Lentigines
• café-au-lait-blotches
• Ephalides
• Benign Naevi such as:
  • Naevus of Ota
  • Naevus of Ito
  • Epidermal Naevi
  • Congenital Naevi
  • Beckers Naevi
  • Blue Nevus
  • Naevus Spillus
  • Mongolian Spot

The device includes a Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064 nm and 500mJ max energy at 532 nm wavelengths, and a Q-Switched Ruby laser source with 1000mJ max energy at 694nm wavelength. The optical delivery system for the three wavelengths is the articulated arm. In addition, the Q-Plus T includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.

Here's an analysis of the provided text regarding the Quanta System Q-Plus T device based on your request:

Acceptance Criteria and Study for Quanta System Q-Plus T (K073549)

The provided submission for the Quanta System Q-Plus T is a 510(k) premarket notification. This type of submission establishes "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated clinical study with defined performance metrics in the same way a PMA (Premarket Approval) might require.

Therefore, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device, and that any minor technological differences raise no new issues of safety or effectiveness.

The "study" that proves the device meets these criteria is the submission itself, which primarily focuses on a comparison to predicate devices and an assessment of the device's technical specifications.

1. Table of Acceptance Criteria and Reported Device Performance

• Treatment of vascular lesions
• Pigmented lesions removal
• Hair removal
• Tattoo removal
• Incision, excision, ablation, vaporization of soft tissue for general dermatology | Q-Plus T Q-Switched laser is intended for:
• Treatment of vascular lesions
• Pigmented lesions removal
• Hair removal
• Tattoo removal
• Incision, excision, ablation, vaporization of soft tissue for general dermatology
  (Matches predicate's intended uses) |
  | Intended Uses / Indications for Use (Ruby 694nm):
• Cutting, vaporization, ablation of soft tissue
• Removal of tattoos
• Removal of benign pigment lesions (e.g., Lentigines, café-au-lait-blotches, Ephalides, various benign Naevi) | Q-Plus T Q-Switched laser is intended for:
• Cutting, vaporization, ablation of soft tissue
• Removal of tattoos
• Removal of benign pigment lesions (e.g., Lentigines, café-au-lait-blotches, Ephalides, various benign Naevi)
  (Matches predicate's intended uses) |
  | Technological Characteristics:
• Q-Switched Nd:YAG laser source (1064nm, 532nm)
• Q-Switched Ruby laser source (694nm)
• Specific energy outputs (e.g., 1000mJ max at 1064nm, 500mJ max at 532nm, 1000mJ max at 694nm)
• Optical delivery system (articulated arm)
• Power supply, cooling system, microprocessor controller, safety features | Q-Plus T includes:
• Q-Switched Nd:YAG laser source with 1000mJ max energy at 1064nm and 500mJ max energy at 532nm.
• Q-Switched Ruby laser source with 1000mJ max energy at 694nm.
• Optical delivery system for the three wavelengths is the articulated arm.
• Includes power supply, cooling system, optical delivery system, microprocessor based controller, and safety features.
  (Technological characteristics are described and presented as similar to predicate, with specific energy outputs stated.) |
  | Principles of Operation:
• Q-Switched laser operation for specific wavelengths | Q-Plus T:
• Operates as a Q-Switched laser system with Nd:YAG and Ruby sources.
  (Principles of operation are implicitly similar to predicate based on technology and intended use.) |
  | Safety and Effectiveness:
• No new issues of safety or effectiveness raised by technological differences. | Conclusion:
• "The Quanta System Q-Plus-T is as safe and effective as the predicate devices."
• "The minor technological differences between the Q-Plus T and its predicate devices raise no new issues of safety or effectiveness."
  (This is the ultimate conclusion based on the comparison.) |

2. Sample Size Used for the Test Set and Data Provenance

This is a 510(k) submission, and the provided text does not describe a clinical study with a "test set" in the traditional sense for the new device's performance. The substantial equivalence argument relies on comparing the device's technical specifications and intended uses to established predicate devices that have prior market clearance. Therefore, there is no specific sample size or data provenance of a test set for this type of submission as the primary evidence is a comparison to predicates and technical documentation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As there was no traditional test set with human assessments requiring ground truth establishment, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. No such clinical test set or adjudication process is described in the provided text for the new device.

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

No. The provided text does not mention any MRMC comparative effectiveness study or an effect size for human readers improving with or without AI assistance. This device is a laser surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical laser device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices as previously cleared by the FDA and the technical specifications of the new device demonstrating its similarity to these predicates. There is no external, independent ground truth (like pathology or outcomes data) that directly evaluates the Quanta System Q-Plus T's performance in a de novo manner within this submission.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI/ML algorithm.

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