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The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis; incision, excision, vaporization, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Photocoagulation of telangiectasia, venulectasia of the legs and face Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi

The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.

The provided text is a 510(k) summary for the DC 7 Diode Laser Therapy System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The DC 7 device is a diode laser therapy system. The acceptance criteria are based on substantial equivalence to predicate devices rather than meeting specific performance metrics in a clinical study. The device meets "acceptance criteria" by demonstrating that its technical and functional characteristics are either identical or sufficiently similar to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

Table of Acceptance Criteria (based on comparison to predicate devices) and Reported Device Performance (DC 7):

Study Details

The provided document (510(k) summary) explicitly states:

• Non clinical Performance Data: None
• Clinical Performance Data: None

This means that a traditional "study" to prove the device meets acceptance criteria in terms of performance was not performed in the context of this 510(k) submission. Instead, the "study" demonstrating that the device meets criteria is a comparative analysis proving substantial equivalence to predicate devices, which is sufficient for 510(k) clearance for this type of device.

Given the absence of clinical/non-clinical performance data, the following points cannot be addressed as no such studies were conducted or presented in this summary:

1. Sample size used for the test set and the data provenance: Not applicable, as no test set data from performance studies were provided. The "test set" here would implicitly be the specifications of the predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was not established via expert review in this submission.
3. Adjudication method for the test set: Not applicable.
4. 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 surgical laser, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser.
6. The type of ground truth used: For the purpose of this 510(k), the "ground truth" for proving substantial equivalence comes from the established safety and effectiveness of the legally marketed predicate devices, against which the DC 7's technical specifications are compared.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the clearance for the DC 7 is based on a demonstration of substantial equivalence to predicate devices through a detailed comparison of technical specifications, rather than new performance studies with specific acceptance criteria that would typically involve test sets, expert ground truth, or statistical analysis of clinical outcomes.

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