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The Noveon™ (Model LS1100-01-0968) delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue.

Device Description

The Noveon™ (Model LS1100-01-0968) is a Class IV Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology. The device consists of the following components and accessories:

Laser Source and Control Unit: Two Class IV laser diodes, each providing continuous-wave laser light, one at the 870 mm and one at 930 nm wavelength. The power output of each laser is selectable from 1W to 8W in 0.1 W increments. There are two touch sensitive screens to control the optical power output of each laser and a separate emergency on/off button.
Foot Pedal Switch: turns the lasers on/off when the lasers are enabled.
Flexible Optical Fiber and End Piece: designed to be lightweight for holding the distal end of the fiber comfortably in the hand to perform procedures.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Nomir Noveon™ (Model LS1100-01-0968)

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel clinical effectiveness or setting specific numerical performance targets for sensitivity, specificity, or similar metrics. The acceptance criteria are therefore largely based on compliance with regulatory standards and comparable performance to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Regulatory Compliance (Performance Standards)	21 CFR 1040.10 and 21 CFR 1040.11: Applicable performance standards for light-emitting products.	The Noveon™ (Model LS1100-01-0968) complies with applicable performance standards as outlined in 21 CFR 1040.10 and 21 CFR 1040.11.
Regulatory Compliance (Electrical/Electromagnetic)	47 CFR Part 15, Subpart B Unintentional Radiator Class A: Conformance for electromagnetic compatibility.
IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2: Applicable voluntary electrical equipment standards.	The device has been tested and verified by Intertek ETI Semko as conforming to 47 CFR Part 15, Subpart B Unintentional Radiator Class A.
"Prior to introduction into the US market, the device will be tested and verified to conform to the applicable voluntary electrical equipment standards..." (This indicates a commitment, not necessarily completed at the time of submission for the latter set).
Biocompatibility	ISO 10993-5 (Cytoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Irritation): Standards for biocompatibility.	The device conforms to the standards for biocompatibility as given by Cytoxicity: ISO 10993-5, Sensitization: ISO 10993-10, and Irritation: ISO 10993-10.
Functional Performance (Surgical Procedures)	Capability to perform incision, contact coagulation, non-contact coagulation, debridement, curettage, and excision satisfactorily.
No adverse events.	A surgical study with a live Yorkshire pig demonstrated the device satisfactorily performed these procedures when used by a medical professional. No adverse events were noted. The study involved 130 passes (127 in contact mode) across various procedures.
Substantial Equivalence (Tissue Effect)	Tissue effect (zone of ablation, coagulation, total destruction) comparable to a 940 nm predicate device, with any differences not of clinical significance.	Testing on porcine skin, muscle, and liver with various wavelengths (940 nm, 930 nm, 870 nm, and combinations) showed that "the difference in tissue effect was comparable to the 940 nm predicate device and any differences were not of clinical significance."
Safety and Effectiveness	Device is safe and effective for indicated medical procedures, consistent with predicate devices that have demonstrated clinical effectiveness.	The device "is designed in accordance with both mandatory and voluntary Standards ensuring it is both safe and effective for the medical procedures indicated above." "No new clinical indications are to be provided by the introduction of the device as compared to the predicate devices, identified above, which have previously demonstrated clinical effectiveness."

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

Animal Study: A single "live Yorkshire pig" was used for the surgical capability test. This is an animal model.
Tissue Sample Study: Porcine skin, muscle, and liver tissue samples were used for the in-vitro tissue effect comparison. The exact number of individual samples is not specified, but it states "individual samples" and "testing was performed in triplicate." This is also an animal model / ex-vivo study.
Provenance: All data appears to be from prospective studies specifically conducted for this submission, utilizing animal models (Yorkshire pig, porcine tissue). There is no mention of human data, retrospective data, or country of origin beyond "porcine."

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

The text does not explicitly state the "number of experts" or their specific "qualifications" involved in establishing ground truth in the manner typically seen for diagnostic devices (e.g., radiologists interpreting images).

Surgical Study: The "medical professional" who performed the procedures on the Yorkshire pig implicitly established the ground truth for "satisfactorily performed." No specific qualifications for this individual are provided.
Tissue Sample Study: The process of recording "the width and depth of the zone of ablation, the zone of coagulation (necrosis) and the zone of total destruction" would have been performed by technical staff or researchers, likely under the supervision of experts, but no details are given. The interpretation that differences were "not of clinical significance" would have been made by medical or scientific experts involved in the study. No specific number or qualifications are given for these experts.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth regarding the device's performance in either the animal surgical study or the tissue sample study.

For the surgical study, the assessment of "satisfactorily performed" and "no adverse events" appears to be based on the observations of the performing medical professional and other study personnel.
For the tissue sample study, the measurements of ablation/coagulation zones were recorded, and the conclusion about clinical significance appears to be an overall assessment based on those measurements and comparison to the predicate, rather than a formal adjudication process between multiple independent readers.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The Noveon™ is a surgical laser, and its evaluation focuses on its direct functional performance, safety, and equivalence to existing surgical lasers.

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

Not applicable. The Noveon™ is a physical surgical laser device, not an algorithm or AI system that operates in a standalone capacity. Its performance is its "standalone" performance, but always with a human operator. The performance testing described (surgical study, tissue sample study) inherently reflects the device's capabilities when operated by a user.

7. Type of Ground Truth Used

Animal Surgical Study: The ground truth for satisfactory performance and absence of adverse events was based on direct observation and clinical assessment by a medical professional during the live animal procedure.
Tissue Sample Study: The ground truth for tissue effects (ablation, coagulation, destruction zones) was based on direct physical measurement and histological assessment of the treated porcine tissue samples. The comparison to the predicate device for clinical significance also falls under expert interpretation of these measurements.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (laser), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and engineering of the laser are based on established physics and prior medical device development knowledge, not on a data training set.

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

Not applicable. As explained in point 8, there is no "training set" for this device.

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