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Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.

Periogenix consists of thirty (30) disposable, single use dental trays and a canister of topical periodontal paste (TPP). The TPP is dispensed into the single use disposable dental tray, which together provide a moist temporary physical barrier that covers the site of application to avoid further irritation.

The provided text describes a 510(k) summary for a medical device called Periogenix, a periodontal wound dressing. However, this document does not contain specific acceptance criteria, reported device performance metrics, or details about a study that "proves" the device meets acceptance criteria in the way that would typically be presented for an AI/ML device (e.g., sensitivity, specificity, or AUC).

The document states that "Biocompatibility, animal, and clinical testing have been performed and have shown that the proposed Periogenix is safe and effective for its intended use." This indicates that studies were conducted to support the device's safety and effectiveness for its intended use, which is protecting injured periodontal tissue. However, the results and specific acceptance criteria from those studies are not detailed in this 510(k) summary.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study details cannot be extracted from this document, as it pertains to a physical medical device (periodontal dressing) and not an AI/ML system.

Here's a breakdown of what can be inferred or stated as missing based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "90% reduction in irritation"). The general acceptance criterion is that the device "is safe and effective for its intended use," as determined by the performed biocompatibility, animal, and clinical testing.
• Reported Device Performance: Not detailed in terms of quantifiable outcomes. The document generally states that testing "has shown that the proposed Periogenix is safe and effective for its intended use." Specific performance metrics from these studies are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. "Clinical testing" is mentioned, implying human subjects were involved, but the number is not provided.
• Data Provenance: Not specified. The country of origin and whether the data was retrospective or prospective are not mentioned.

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 is not applicable as the device is a physical periodontal dressing, not an AI/ML system requiring expert-based ground truth for image interpretation or diagnosis. The "ground truth" would likely relate to clinical outcomes (e.g., healing, reduction in irritation) observed in patients by clinicians.

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

• Not applicable for this type of device and study description. Clinical trial outcomes are typically assessed by clinicians and statisticians in a different manner than an AI/ML system's performance on a test set.

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 not an AI/ML device.

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

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

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

• For a periodontal dressing, the "ground truth" for showing effectiveness would likely be based on clinical outcomes data (e.g., assessment of wound healing, reduction of pain/irritation, absence of adverse events) in subjects who used the device, possibly compared to a control group or predicate devices, as observed and documented by clinicians.

8. The sample size for the training set

• Not applicable for this type of medical device. The concept of a "training set" is relevant to machine learning, not typical clinical evaluations of physical devices. The "clinical testing" would involve a cohort of patients, but they are not a "training set" in the AI sense.

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

• Not applicable.

Summary based on the provided text:

The document broadly states that biocompatibility, animal, and clinical testing were performed to demonstrate the device's safety and effectiveness for its intended use. However, it does not provide the specific quantitative acceptance criteria or detailed performance results from these studies. It also does not discuss AI/ML-specific concepts like test sets, training sets, expert adjudication, or MRMC studies.

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The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery.

The Curative980 Diode Lasers (and the delivery accessories that are used with them to deliver laser energy) is indicated for use in a variety of applications requiring incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery.

The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows:

Dental Surgery

Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:

• Biopsy
• Excisional and incisional biopsies
• Excision of lesions
• Exposure of unerupted/partially erupted teeth
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival troughing for crown impressions
• Gingival troughing
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis and coagulation
• Hemostasis of donor site
• Implant recovery
• Removal of granulation tissue
• Laser assisted flap surgery
• Debridement of diseased epithelial lining
• Treatment of aphthous ulcers
• Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
• Laser soft tissue curettage
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Operculectomy
• Incision and drainage of abscess
• Oral papillectomies; papillectomy
• Removal of hyperplastic tissues
• Pulpotomy
• Pulpotomy as an adjunct to root canal therapy
• Reduction of gingival hypertrophy
• Reduction of bacterial level (decontamination) and inflammation
• Soft tissue crown lengthening; crown lengthening
• Tissue retraction for impressions
• Leukoplakia
• Vestibuloplasty
• Light activation of bleaching materials for teeth whitening.
• Laser-assisted bleaching/whitening for teeth

The Curative980 Diode Lasers are comprised of the following main components:

• Main console containing the major electrical components, including:
• Control Touch-Screen Display Panel including touch controls;
• 980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode);
• 650 nm aiming beam diode laser;
• Delivery device fiber-optic connector port;
• Emergency stop switch;
• Remote interlock connector (External door interlock connector);
• Connector ports for the footswitch and power cord;
• Handpiece holder (attaches to the top of the laser system console);
• Fiber Spool (secures and organizes the optical fiber) attaches to the side of the main console;
• Footswitch:
• Medical grade power cord;
• Delivery Devices:
• Optical Fibers - Reusable, cleanable, sterilizable optical fibers;
• Handpieces -Reusable, cleanable, sterilizable handpieces;
• Handpiece Tips - Disposable single-use tips;
• Accessories:
• Safety Glasses
• Tools:
• Optical Fiber Striper;
• Optical Fiber Cleaver.

The provided text is a 510(k) summary for a medical device (OroScience Curative980 Diode Lasers). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you've described for, say, an AI diagnostic tool.

Therefore, the information you're asking for regarding acceptance criteria, performance tables, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.

The core of a 510(k) summary for a device like this laser is to show that it has the same or similar:

• Indications for Use
• Device Operation
• Overall Technical and Functional Specifications

And that any differences do not raise new questions of safety or effectiveness. The "study" here is essentially a comparison to predicate devices, not a clinical trial against specific performance metrics with a ground truth established by experts.

Here's a breakdown of why this information isn't present in the provided text, using the structure of your request:

1. Table of acceptance criteria and the reported device performance:

   • N/A. This document doesn't define specific numerical acceptance criteria for performance; rather, it asserts substantial equivalence to existing predicate devices. The "performance" is implicitly deemed equivalent if the device functions similarly and has the same indications for use as the predicates.

2. Sample size used for the test set and the data provenance:

   • N/A. There isn't a "test set" in the sense of clinical data evaluating the device's diagnostic or treatment efficacy against a ground truth. The submission relies on engineering and design comparisons.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No ground truth needed to be established by experts for a test set in this kind of submission.

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

   • N/A. No test set or expert adjudication was performed as described.

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:

   • N/A. This is a laser surgical instrument, not an AI-assisted diagnostic tool. MRMC studies are irrelevant here.

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

   • N/A. Again, this is a physical medical device (laser), not an algorithm.

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

   • N/A. No ground truth in this context. The "truth" being established is that the device is substantially equivalent to legally marketed devices.

8. The sample size for the training set:

   • N/A. This device doesn't use machine learning or require a training set.

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

   • N/A. No training set exists for this type of device.

In summary, the "study" proving the device meets "acceptance criteria" in a 510(k) context is the demonstration of substantial equivalence to existing predicate devices based on design specifications, intended use, and operational principles, not a clinical trial with performance metrics against a defined ground truth.

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