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The Novilase® Laser Therapy System (LTS-2) is indicated for the treatment of the breast, with tumor sizes up to 20 mm, and for general surgery procedures including incision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

Device Description

The Novilase Laser Therapy System (Model LTS-2) is a second-generation laser-based system that uses laser ablation to destroy tumors via a minimally-invasive procedure

AI/ML Overview

The provided text is a 510(k) Special Summary for the Novilase Laser Therapy System, Model LTS-2. It primarily focuses on demonstrating substantial equivalence to a predicate device (Kelsey Interstitial Laser Therapy System, Model ILT) rather than presenting a performance study with a test set, ground truth establishment, and detailed acceptance criteria for a new and complex AI/software device.

The document states:

"In addition, no new issues pertaining to biocompatibility have been raised and therefore no clinical data was acquired." This is a crucial point that indicates the absence of a comprehensive clinical performance study as would be expected for an AI/software device.
The reason for the Special 510(k) is "Repackaging of the hardware to decrease size and weight and improve aesthetics, user interface modifications including the introduction of a touch-screen monitor." These are primarily physical and user interface changes, not changes to the fundamental operating principle or diagnostic/treatment algorithm.
The comparison tables (Table 2-3.1) focus on features, specifications, and components, demonstrating that the new device operates in an identical fashion to the predicate device, with minor updates (e.g., operating system, touch screen).

Therefore, based on the provided text, it's not possible to generate the requested information about acceptance criteria, a test set, ground truth, or an MRMC study that would be typical for an AI-powered medical device. The "study" proving the device meets acceptance criteria appears to be a comparison to a predicate device showing substantial equivalence in functionality and safety specifications, rather than a clinical trial or performance evaluation against a defined ground truth for a new algorithm.

Here's an attempt to answer the questions based only on the provided text, acknowledging its limitations for an AI/software context:

Acceptance Criteria and Device Performance (Based only on the provided document's equivalence claim):

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (Novilase LTS-2 compared to predicate ILT)
Functional Equivalence: Device performs the same intended use.	"Both devices have the same intended use." "Both devices operate in an identical fashion."
Indication Equivalence: Device is indicated for the same uses.	"Both devices have the same indications for use statement."
User & Environment Equivalence: Same intended user and use environment.	"Both devices have the same intended user profile." "Both devices have the same intended use environments."
Patient Population Equivalence: Targets the same patient population.	"Identical patient populations."
Performance Specification Equivalence: Core performance parameters (e.g., laser type, wavelength, power, treatment mode) are identical.	"GaAIAs Laser Diode, 805 nm ± 15 nm, 1-8 watts, Continuous operation, Multimode optical output, Internal/automatic ± 20% calibration, 600 µm core diameter." (All identical to predicate).
Safety and Effectiveness Equivalence: Changes do not raise new questions of safety or effectiveness.	"The modifications do not raise new questions of safety or effectiveness and the device continues to meet its specifications." "No new issues pertaining to biocompatibility have been raised and therefore no clinical data was acquired." "Same or better safety standards are met."
Component Equivalence/Acceptability: Updated components (e.g., OS, display) are suitable and validated to meet specifications.	"PC Environment updated per new standard operating systems; As emulated, identical to predicate." "V&V testing... demonstrates that when used with the specified computer, the device continues to meet its performance specifications." "Increased input functionality by adding touch screen functionality."
Physical/Ergonomic Equivalence/Acceptability: Physical changes (size, weight, mobility) do not negatively impact use or safety.	"The new device is slightly taller in its maximal height. This does not have an impact on the use environment." "The new unit is lighter in weight by 70 lbs. Increased mobility. This does not have an impact on the use environment or intended user." "The larger diameter wheels add to the mobility and stability."
Environmental Operational Equivalence/Acceptability: Operating and storage environmental specs are met or improved without safety concerns.	"The specifications for the operating environment have been tightened for increased control and environmental consistency... This does not raise new questions of safety or effectiveness." "The storage environment specifications... do not have an impact on device performance and do not raise new questions of safety or effectiveness."

Study Details (based only on the provided document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this 510(k) Special Summary. No distinct "test set" for performance evaluation of a new algorithm is mentioned. The submission relies on substantial equivalence to a legally marketed predicate device.
- Data Provenance: Not applicable as no clinical data or performance data from a specific test set is presented. The document states "no clinical data was acquired."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment is described as there was no test set for clinical performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
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:
- No. An MRMC study was not done, and this device is not described as involving AI assistance for human readers. It is a laser therapy system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser therapy system, not an algorithm, and its performance relies on the device's physical and functional specifications.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established for a performance study. The "truth" in this submission relies on the established safety and effectiveness of the predicate device and the demonstration that the new device is fundamentally the same despite minor modifications.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

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