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The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions.

The SL3 laser is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.

The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed:

-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth

The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAIAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. The SL3™ is designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures.

This document is a 510(k) Pre-market Notification for a medical device called SL3, a surgical laser system. It focuses on establishing substantial equivalence to previously cleared devices rather than primarily presenting a study to prove performance against acceptance criteria in the traditional sense of a clinical trial for diagnostic accuracy or treatment efficacy.

Therefore, many of the requested categories for a study proving device performance (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in this type of regulatory submission.

The acceptance criteria here are implicitly related to the technical specifications and safety profile being substantially equivalent to the predicate devices. The "study" proving this is essentially the comparison table and the demonstration that the SL3 meets similar performance characteristics and safety standards as the predicate devices.

Here's the information parsed from the document based on your request, with explanations for what is not applicable to this type of submission:

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

For a 510(k) submission, "acceptance criteria" are not typically formal performance metrics in the way they would be for a diagnostic AI study. Instead, they are implicit in the substantial equivalence comparison - meaning the new device must perform comparably to the predicate devices and meet relevant safety and essential performance standards. The "reported device performance" is largely represented by its technical 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 / Not Provided: This is a 510(k) pre-market notification for a laser device, not an AI or diagnostic device requiring a "test set" in the context of clinical performance data. The submission relies on technical comparisons and safety data, not a patient-level data set.

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 "test set" or "ground truth" in this context as described for diagnostic or AI systems. The "ground truth" for a laser device would relate to engineering specifications, safety standards, and pre-clinical testing, which are performed by engineers and regulatory experts, not typically by medical experts establishing diagnostic ground truth from patient data.

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

• Not Applicable: No test set requiring annotation adjudication.

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 is a surgical laser device; MRMC studies are used for diagnostic imaging systems, not for comparing human performance with and without a surgical instrument like a laser.

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

• Not Applicable: This device is a surgical instrument intended for human operation, not a standalone algorithm.

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

• Type of Ground Truth: For this device, the "ground truth" is primarily based on engineering specifications, recognized national and international safety standards (e.g., laser safety standards), and the established performance and safety profiles of the predicate devices. Compliance with these technical and safety standards, along with successful pre-clinical testing (which would include electrical safety, EMC, laser emission measurements, etc.), forms the basis of "proof." There is no patient-level "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not Applicable: No "training set" as this is not an AI or machine learning device. Device development involves engineering design, prototyping, and testing, not data-driven training.

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

• Not Applicable: No training set.

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The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

This document is a 510(k) clearance letter from the FDA for a dental handpiece (Zen Cordless Prophy System). It states that the device is substantially equivalent to legally marketed predicate devices.

The information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document. This letter and its enclosure ("Indications for Use Statement") only confirm FDA clearance and describe the intended use of the device. It does not contain any details about performance studies or acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions based on the provided text.

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Nuance Universal Composite:

• Direct restorations of anterior or posterior teeth (Class I Class V) .
• Diastema closures .
• Intraoral repairs of fractured crowns/bridges ●

Nuance Posterior Composite:

• Direct restorations of Class I and Class II cavities .

Nuance Flowable Composite:

• Direct restorations of anterior or posterior teeth .
• Cavity base/liner .
• Intraoral repairs of fractured crowns/bridges .

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Discus Dental, LLC concerning dental composite materials. It is a regulatory document and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information to fill in the table or answer the questions. The document is strictly about the FDA's decision on the substantial equivalence of the dental composites to legally marketed predicate devices.

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SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). SimpliSeal is intended for use by qualified healthcare personnel trained in its use.

SimpliSeal is a root canal sealer delivered in a dual-barrel syringe. This epoxy based resin sealer is easy to use with gutta-percha points and can also be used with established and more recent root canal sealing techniques. SimpliSeal with colaonent obturation of root canals when combined with obturation points.

The provided text describes the "SimpliSeal" root canal sealer and its substantial equivalence to predicate devices, focusing on physical and biocompatibility tests. However, it does not contain a study that proves the device meets specific acceptance criteria in the context of AI or machine learning performance as requested. The document is a 510(k) summary for a medical device approval by the FDA, which relies on demonstrating equivalence to existing legally marketed devices, rather than a clinical study with detailed performance metrics against specific acceptance criteria for AI.

Therefore, many of the requested fields regarding AI/ML study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable to this document.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

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

The document lists various tests performed on SimpliSeal and states that "All testing is within specification and the device performs as designed." It also compares SimpliSeal's physical properties to predicate devices (Adseal and AH-Plus) implying these shared properties serve as the performance benchmarks. However, the specific quantitative acceptance criteria (e.g., "fluidity must be X-Y mm") are not explicitly stated within the text, only the type of test (e.g., "ISO 6876 fluidity"). The reported performance is a qualitative statement of meeting specifications rather than specific numerical results.

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 provided in the document. The document describes laboratory tests, not a clinical study involving a test set of data in the context of AI.

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 provided as the device is not an AI/ML diagnostic tool, and the "ground truth" for its performance is based on standardized laboratory testing rather than expert-labeled clinical data.

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

This information is not provided as the device is not an AI/ML diagnostic tool, and no multi-reader adjudication process is mentioned for its performance assessment.

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 provided. The device is a root canal sealer, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

This information is not applicable. The device is a physical product (root canal sealer), not an algorithm.

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

The "ground truth" for this device's performance is established by standardized laboratory test methods (ISO 6876 and ISO 10993 series). The performance is assessed against the specifications outlined in these international standards for dental materials and biocompatibility.

8. The sample size for the training set

This information is not provided and is not applicable as the device is not an AI/ML model.

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

This information is not applicable as the device is not an AI/ML model.

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The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and performs the instrumentation. The tips are offered in two frequencies, six different colors and twenty different tip styles.

The provided text is a 510(k) summary and FDA clearance letter for the Insight Ultrasonic Inserts. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The document is a regulatory submission focused on demonstrating substantial equivalence to already cleared devices, rather than presenting a performance study with detailed acceptance criteria and study data as one might find for a novel device requiring more rigorous clinical validation.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided input, nor can I answer the specific questions about sample sizes, expert qualifications, or study methodologies because this information is not present in the text.

The document indicates that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar to those devices without necessarily undergoing a new performance study against explicit acceptance criteria in this specific submission.

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