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Treatment of Dental Hypersensitivity for use in adults over the age of 21.

The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Centrix FluoroSilver Silver Diamine Fluoride 38%). This type of document is provided when a company seeks to demonstrate that their new device is substantially equivalent to a legally marketed predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through various performance and material characteristic comparisons, rather than clinical efficacy trials with predefined clinical acceptance criteria as would be typical for a PMA.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant standards. The goal is to show the new device is "substantially equivalent."

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

The document does not explicitly state a "test set" in the sense of a clinical trial for performance. Instead, it describes various laboratory and in vitro/in vivo (animal) studies for substantial equivalence.

• Cytotoxicity (ISO 10993-5): No specific sample size mentioned, likely standardized by the ISO method.
• Skin Sensitization (ISO 10993-10): No specific sample size mentioned, likely standardized by the ISO method (typically animal models).
• Irritation (ISO 10993-23): No specific sample size mentioned, likely standardized by the ISO method (typically animal models for oral mucosa).
• Acute Systemic Toxicity (ISO 10993-11): No specific sample size mentioned, likely standardized by the ISO method (typically animal models like rats or mice).
• SEM Analysis: "Human tooth samples" used. Number not specified.
• Fluoride Release Testing: "SDF treated tooth cross sections" used. Number not specified.
• Dentin Permeability: "Human molar teeth samples" used. Number not specified, but the results include standard deviations, implying a sample size greater than one.

Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that these are bench and preclinical studies for a 510(k), they are generally prospective laboratory studies. "Human molar teeth samples" would typically be ethically sourced from dental extractions.

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

This type of information is generally not applicable to a 510(k) submission for substantial equivalence based on bench/preclinical testing. There is no "ground truth" established by experts in the context of interpreting images or clinical outcomes data. The "ground truth" for the tests mentioned (e.g., cytotoxicity, fluoride release, dentin permeability) is determined by the objective measurements and protocols of the respective ISO standards or laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or expert consensus on qualitative data (e.g., image interpretation, clinical diagnosis). The studies presented are objective, quantitative laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, typically in interpreting medical images, with and without AI assistance. The device in question (Centrix FluoroSilver Silver Diamine Fluoride 38%) is a chemical product for treating dental hypersensitivity, not an imaging or diagnostic AI device.

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

Not applicable. This device is a chemical substance, not a software algorithm or an AI device. The term "standalone performance" for an algorithm does not apply here. The performance of the substance itself was evaluated.

7. The Type of Ground Truth Used

The "ground truth" used for these substantial equivalence tests were objective, quantitative measurements and observations derived from standardized laboratory tests:

• Cytotoxicity: Observation of cellular response in vitro according to ISO 10993-5.
• Skin Sensitization: Dermal response in animal models according to ISO 10993-10.
• Irritation: Mucosal response in animal models according to ISO 10993-23.
• Acute Systemic Toxicity: Clinical observations and necropsy findings in animal models according to ISO 10993-11.
• SEM Analysis: Direct microscopic observation of silver deposition on tooth samples.
• Fluoride Release Testing: Quantitative measurement of fluoride concentration.
• Dentin Permeability: Quantitative measurement of water flow through dentin.
• Chemical Identity Testing: Mass Spectrometry data for chemical composition.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm. The device is a chemical product.

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

Not applicable, for the same reason as above.

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StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.

The provided FDA document describes the premarket notification (510(k)) for the StatStix device (K200764). It details the device's intended use and compares its characteristics to a predicate device for substantial equivalence. However, it explicitly states that clinical testing has not been performed on this product. Therefore, a study proving the device meets acceptance criteria based on clinical performance in humans is not present in this document.

The document does, however, discuss non-clinical performance data and establishes acceptance criteria for those tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

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

• Clinical Test Set: Not applicable, as no clinical testing was performed for StatStix.
• Non-Clinical Test Set: Not specified for biocompatibility, physical properties, or shelf-life testing. The document states "standard laboratory benchtop practices" for physical properties and "consistent with ASTM F1980" for shelf-life, implying standard sample sizes for these types of tests would have been used, but specific numbers are not detailed.
• Data Provenance: Not explicitly stated, but assumed to be from Centrix Incorporated or their contracted laboratories given they are the submitter.

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

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not specified. For non-clinical lab tests, "ground truth" is established by the methodologies and reference standards themselves, as opposed to expert human interpretation.

4. Adjudication Method for the Test Set:

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not applicable. Adjudication methods are typically relevant for subjective assessments or when multiple human readers/experts are involved in ground truth establishment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "Clinical testing has not been performed on this product." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance. The StatStix device is a physical product (applicator with astringent), not an AI-powered diagnostic or assistive tool.

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

• No, a standalone performance study in the context of an algorithm or AI was not done. StatStix is a physical device, not an algorithm.

7. Type of Ground Truth Used:

• Clinical Ground Truth: Not applicable, as no clinical testing was performed.
• Non-Clinical Ground Truth: Established through standardized laboratory testing methodologies (e.g., ISO, ASTM, FTIR/pH/dosage weight analysis) where the outcomes are measurable and objective.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/machine learning algorithm requiring a "training set" of data.

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

• Not applicable, as there is no training set for this type of device.

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NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord

1. Retracts the gingival tissue to expose the sub-gingival margin
2. Controls gingival bleeding
3. Reproduces the structure of a patient's teeth and gums

NoCord is a low viscosity vinyl polysiloxane impression material.

I am sorry, but the provided text is a 510(k) clearance letter for a dental impression material without any information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the information requested in your prompt.

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Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.

Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.

This document describes a medical device, the "Benda Wedge," which is a dental wedge coated with a hemostatic agent. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously cleared devices rather than providing extensive de novo clinical trial data.

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific reduction in bleeding, retention strength, etc.). Instead, the entire submission is built around demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use, with the added benefit of a hemostatic agent.

Therefore, the table below reflects the primary claim of similarity rather than specific performance numbers.

1. Sample sizes used for the test set and data provenance:

• Test Set Sample Size: "Clinical testing has not been performed on this product." Therefore, there is no test set in the traditional sense, and thus no sample size for clinical performance evaluation. Non-clinical biocompatibility testing was performed, but sample sizes for this are not specified in the summary.
• Data Provenance: Not applicable, as no clinical testing was performed.

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

• Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

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

• Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

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 physical dental wedge, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical dental wedge, not an algorithm.

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

• Not applicable, as no clinical testing was performed. For the biocompatibility testing, the ground truth would typically be established by standardized laboratory tests and evaluations against ISO 10993-1 guidelines, with results interpreted by qualified toxicologists or materials scientists.

7. The sample size for the training set:

• Not applicable. This device is a physical dental wedge and does not involve AI or machine learning that would require a training set.

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

• Not applicable, as no training set was used.

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To relieve dental hypersensitivity.

Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Senzzzzz Away device:

Important Note: The provided 510(k) summary for Senzzzzz Away (K120176) is for a dental cavity varnish. The questions in your prompt are largely tailored towards an AI/Software as a Medical Device (SaMD) product, which often involves metrics like sensitivity, specificity, MRMC studies, and ground truth established by experts. As such, many of the requested fields cannot be directly addressed from this type of regulatory submission for a physical medical device. I will extract all available information and explicitly state when a question cannot be answered from the provided text.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of Inferred Criteria: The 510(k) summary doesn't explicitly state quantitative acceptance criteria or thresholds (e.g., "sensitivity must reduce by X%"). Instead, it describes the purpose of the studies, from which we can infer the criteria for success. The "effectiveness study" aimed to "demonstrate the reduction in sensitivity," implying that a statistically significant reduction in hypersensitivity was the acceptance criterion for effectiveness. The "consumer ease-of-use study" aimed to "ensure that patient use of the product was appropriate for over-the-counter purchase," indicating that the device needed to be readily usable and safe for consumers. The in vitro testing ("Scanning electron microscopy") aimed to show tubule occlusion and sealing, a key mechanism of action.

Study Details

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

• Sample Size:
  • Effectiveness Study: Not explicitly stated. The summary only mentions "A six month effectiveness study was performed."
  • Consumer Ease-of-Use Study: Not explicitly stated. The summary only mentions "A consumer ease-of-use study conducted."
  • Biocompatibility/SEM Study: Not explicitly stated for number of extracted teeth.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified in the provided text. The effectiveness and consumer studies would typically be prospective, but this is not explicitly stated. The biocompatibility/SEM analysis used "extracted teeth," which would be retrospective in terms of tooth origin, but the analysis itself is contemporary.

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

• Not applicable / Not provided. For a dental desensitizer, "ground truth" often refers to clinical endpoints like patient-reported sensitivity or objective measurements of sensitivity. Expert consensus in the traditional sense of image analysis or diagnostic interpretation is not relevant here. The evaluation of effectiveness would typically rely on patient-reported outcomes (e.g., VAS scores for pain) and potentially some objective stimuli (cold, air blast, etc.) assessed by dental professionals, but the number and qualifications of such assessors are not detailed.

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

• Not applicable / Not provided. This concept is generally associated with diagnostic studies where multiple readers interpret cases and their discrepancies are resolved. For a dental desensitizer's effectiveness study, adjudication methods like 2+1 or 3+1 are not typically used. The data would likely be collected directly from subjects and/or through objective measurements by trained clinical staff.

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:

• No. An MRMC study is specific to diagnostic imaging interpretation, often involving AI assistance. This device is a treatment for hypersensitivity. The "effectiveness study" was a clinical trial to demonstrate the device's therapeutic effect, not an MRMC study comparing human reader performance with and without AI.

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

• No. This device is a physical product (cavity varnish) applied by a human, and it does not involve any algorithms or AI for standalone performance evaluation in the way a SaMD would.

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

• Outcomes Data (patient-reported hypersensitivity) and Physical/Biological Evidence (tubule occlusion). The "effectiveness study" would have used methods to assess the reduction in dental hypersensitivity, likely through patient-reported pain scales (e.g., Visual Analog Scale (VAS) or similar) in response to stimuli (cold, hot, sweet, air blast), which are a form of outcomes data. The scanning electron microscopy (SEM) analysis provided direct biological evidence (ground truth) of tubule occlusion, confirming a key mechanism of action.

8. The sample size for the training set:

• Not applicable / Not provided. This device does not use machine learning or AI that requires a "training set." The studies performed were clinical efficacy and consumer usability studies.

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

• Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the described device.

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Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.

Re/Stasis™ is a paste containing kaolin clay and aluminum chloride

This K111348 document is a 510(k) clearance letter from the FDA for a device named Re/Stasis™. This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it. It does not contain acceptance criteria, details of a clinical study, or performance data.

The sections you've asked for (acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are typically found in the submission itself, which is not publicly released in this format, or in a Summary of Safety and Effectiveness Data (SSED) if one were available (which is more common for PMA devices).

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria and study details. The document states that the device is intended for "temporary retraction and hemostasis of the gingival margin during dental procedures." The FDA's determination is based on substantial equivalence, implying that the safety and effectiveness are considered comparable to an existing device without necessarily requiring new clinical trials to demonstrate specific performance metrics for this particular 510(k) submission.

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LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "LiquiCord," which is a dental product.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about specific studies, such as sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
• Information about how ground truth was established for training or test sets.

The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory responsibilities. It states the "Indications for Use" but does not delve into the performance metrics or study designs used to demonstrate the device's efficacy or safety.

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CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.

CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.

The provided text is a 510(k) summary for the CordCap™ device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and ground truth establishment methods.

Based on the provided text, there is no detailed study information available that describes acceptance criteria and how a device's performance meets those criteria in the way typically expected for a clinical trial or performance study of an AI/imaging device.

Here's an analysis of the submission in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "criteria" for acceptance are implicitly that the device is "as safe and effective" as the predicate devices.

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

• Not applicable. This submission does not describe a test set in the context of performance metrics for an AI/imaging device. It relies on a comparison of characteristics and intended use to predicate devices already on the market. There were no human subjects or data sets used for validating specific performance claims.

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

• Not applicable. As there was no test set for performance evaluation, there were no experts used to establish ground truth. Substantial equivalence is determined by regulatory bodies based on documented device characteristics and comparison to predicates.

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

• Not applicable. No test set or adjudication process for performance was 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:

• No. An MRMC study is not relevant for this type of mechanical dental device. This device is not an AI-assisted diagnostic tool.

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

• No. This is a mechanical device, not an algorithm.

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

• Implicit "Ground Truth" of Predicate Devices: The "ground truth" in a substantial equivalence claim is effectively the established safety and effectiveness of the legally marketed predicate devices (Ultrapak NEHA, Stay-Put Impregnated). The new device is deemed acceptable if it can demonstrate it shares the same intended use and technological characteristics, or is as safe and effective, as these predicates.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML system requiring a training set.

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

• Not applicable. No training set was used.

In summary, the provided K091380 document is a 510(k) premarket notification for a mechanical dental device. Its acceptance relies on demonstrating substantial equivalence to already approved predicate devices, not on a detailed clinical study with performance metrics in the way an AI diagnostic device would be evaluated. Therefore, most of the specific questions about acceptance criteria and study details for an AI-like device are not applicable to this submission.

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CLEANING AND Disinfective RESTORA ીચ્ચનો work

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This FDA 510(k) clearance letter for the CHLORAPREP™ device, a cavity varnish (Regulation Name: Cavity Varnish, Product Code: LBH), indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The letter primarily focuses on the regulatory aspects of the clearance, such as:

• Substantial Equivalence: The FDA has determined the device is substantially equivalent to predicate devices.
• Regulatory Classification: The device is classified as Class II (Special Controls).
• Compliance Requirements: It outlines the manufacturer's responsibilities regarding registration, listing, labeling, and good manufacturing practices.

Therefore, I cannot provide the requested information based on the provided text.

To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would typically include:

1. A table of acceptance criteria and the reported device performance: This would detail the specific performance metrics (e.g., bond strength, fluoride release, antimicrobial efficacy) and the thresholds for acceptance, along with the results of tests conducted.
2. Sample size used for the test set and the data provenance: This would specify how many samples were tested and where the data came from (e.g., in vitro lab studies, in vivo animal studies, human clinical trials, and their geographical origin and design).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is more relevant for imaging or diagnostic devices where human interpretation is involved. For a cavity varnish, ground truth would likely be established through objective laboratory measurements or histological analysis.
4. Adjudication method for the test set: Again, more relevant for subjective evaluations. For a material, it would be based on validated assays.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is typically for diagnostic imaging devices, not a cavity varnish.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable to this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Would likely be lab measurements (e.g., chemical composition, physical properties, antimicrobial activity).
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Without the actual study report or performance data from the 510(k) submission, it's impossible to describe the acceptance criteria or the study demonstrating compliance.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called "D/Sense 1-Step." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.

The document does not contain the information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in a clinical study report or a more detailed section of the 510(k) submission itself, which is not provided in the given text. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.

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