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Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.

Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.

Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.

Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.

Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.

Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.

Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called the MiniSpacer Dual Spray MDI Adapter. This document is a regulatory submission for a device, which typically describes an engineering verification and validation study rather than a clinical study for AI software.

Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially details such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set information (which are all highly relevant to AI/ML device evaluations), is not present in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and general performance, rather than AI-specific metrics.

However, I can extract the following relevant information based on the request, reinterpreting some categories in the context of a non-AI medical device submission:

Acceptance Criteria and Device Performance

• Product: MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
• Study Type: This document describes a premarket notification (510(k)) to establish substantial equivalence to predicate devices, not a clinical trial or AI performance study. The "study" here refers to the engineering verification and biocompatibility assessment for the physical device.

Additional Requested Information (as applicable to this document):

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

   • Test Set Sample Size: Not specified in the document. The testing described appears to be bench testing for material and functional equivalence.
   • Data Provenance: Not explicitly stated, but the toxicological assessment and comparisons against predicate devices would be based on internal testing and regulatory standards. It's a regulatory submission, not a clinical trial, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for patient data.

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

   • Not applicable in the context of this device. Ground truth is established through engineering specifications, material standards, and regulatory requirements (e.g., biocompatibility testing interpreted by toxicologists) rather than expert consensus on medical images or patient outcomes.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of expert interpretations. Compliance is determined by engineering testing and regulatory assessment.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

   • No, an MRMC study was not done. This device is a physical medical component (an actuator for MDI medication), not an AI diagnostic or treatment planning system that would involve human readers interpreting data.

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

   • Not applicable. This device does not involve an algorithm or AI component.

6. The type of ground truth used:

   • For material and functional performance, the "ground truth" is defined by established engineering specifications, performance standards, mechanical testing results, and toxicological assessment standards. For regulatory approval, the ultimate "ground truth" is established by demonstrating substantial equivalence to legally marketed predicate devices through comparative analysis and testing.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.

The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are specifically formulated as an artificial saliva substitute with water, moisturizers, humectants, sweeteners, and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia).

The provided document, a 510(k) Pre-market Notification for GuruNanda Dry Mouth Oral Rinse and Spray, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-based medical devices.

This document is a Substantial Equivalence (SE) Determination letter for a non-AI/ML device (dry mouth rinse and spray). In such cases, the primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a predicate device that is already legally marketed. This typically involves comparing intended use, technological characteristics, materials, and performance to the predicate device.

Therefore, many of the specific questions you've asked, which are highly relevant to the evaluation of AI/ML-based medical devices (e.g., sample size for test sets, number of experts, MRMC studies, standalone performance, ground truth establishment), are not applicable to this submission.

Here's a breakdown of what can be extracted from the document in relation to your questions, and what cannot:

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

• Not Applicable in the traditional sense for this type of device. The 'acceptance criteria' for this submission are rooted in demonstrating substantial equivalence to the predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731).
• The "reported device performance" is essentially the comparison table on pages 5-6, which shows an identical intended use, similar design, materials, chemical composition (with minor, stated differences in preservatives), and performance characteristics (e.g., appearance, color, odor, method of use, target population).
• Performance is demonstrated through:
  • Biocompatibility testing: "Cytotoxicity, sensitization, irritation tested and passed in conformity with ISO 10993-5, ISO 10993-10, 10993-23." This is a key safety performance aspect for a device that contacts mucosal membranes.
  • Chemical composition comparison: The document states that differences are minor and do not affect safety and effectiveness, and variations are "designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications."

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

• Not Applicable. This is not an AI/ML device that underwent a clinical performance study with a test set of patient data. Performance is primarily demonstrated through bench testing (like biocompatibility and chemical analysis) and comparison to a predicate.

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

• Not Applicable. Ground truth, in the context of diagnostic or AI performance, is not a concept that applies to this type of device submission.

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

• Not Applicable.

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 imaging or diagnostic device that would use human readers or AI assistance.

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

• Not Applicable. This is not an algorithm-based device.

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

• Not Applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device, and the demonstration that the new device shares fundamentally similar characteristics.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable.

Summary of Device Acceptance/Proof based on this Document:

The acceptance of the GuruNanda Dry Mouth Oral Rinse and Spray is based on its demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731). The "study" proving this meets criteria is primarily a comparison and analysis of attributes rather than a clinical trial or AI performance study:

• Intended Use: Identical ("Relieve the symptoms of dry mouth: refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.")
• Technological Characteristics: Very similar design, materials, and chemical composition. Minor differences in chemical composition (e.g., preservatives) are justified as not impacting safety or effectiveness, citing GRAS status or history of safe use.
• Performance: Demonstrated through:
  • Biocompatibility testing: Confirmed to meet ISO standards (ISO 10993-5, 10993-10, 10993-23) for cytotoxicity, sensitization, and irritation.
  • Chemical analysis: The variations in formula/composition are stated not to alter function or safety.
  • Physical characteristics: Similar appearance, color, odor.
  • Shelf-life: While the predicate had a 3-year shelf life and the new device a 2-year shelf life, this difference was presumably accepted as not raising new questions of safety or effectiveness.

In essence, the "proof" is that the device is so similar to an already cleared device that it does not raise new questions of safety or effectiveness.

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Prescription Use:
S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
OTC:
S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.

S.E.A.L. Hemostatic Wound Spray is composed of chitosan dry powder in spray form that provides a physical barrier or seal to stop the flow of blood. When sprayed on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. S.E.A.L. quickly forms a strong seal that completely covers the wound. S.E.A.L. is presented for both Prescription and over-the-counter (OTC) use.

The S.E.A.L. Hemostatic Wound Spray's acceptance criteria and the studies that demonstrate its compliance are detailed below. It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performance against those criteria. Therefore, the "acceptance criteria" are implied by the equivalence demonstration, and performance is reported relative to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides details for animal studies:

• Rat liver model: Used for biological safety and non-inferiority assessment. The specific number of animals is not stated.
• Standard swine hemorrhage model: Used for efficacy assessment. The specific number of animals is not stated.
• Data Provenance: The studies were conducted as "In vivo performance animal studies" to support substantial equivalence. The country of origin is not specified but contract labs were mentioned for biocompatibility tests. The studies are prospective in nature, as they are experiments designed to evaluate the device.

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

The document does not mention the use of human experts to establish ground truth for the test set. The efficacy and safety studies were conducted in animal models, likely assessed by researchers and veterinarians. For the biocompatibility tests, the results are based on standardized laboratory protocols (e.g., ISO, USP).

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to animal subjects used in experimental studies, not a human reader study with adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a hemostatic wound spray, not an imaging device or diagnostic tool that would typically involve human readers interpreting results.

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

Not applicable. This device is a medical product (hemostatic spray), not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device.

7. The Type of Ground Truth Used

• For Hemostatic Efficacy: Ground truth was established through direct observation and quantitative measurements in live animal models (e.g., bleeding time, blood loss, survival time, gross necropsy, histopathology).
• For Biocompatibility: Ground truth was established against international standards and validated laboratory methods (e.g., ISO 10993-1 for cytotoxicity, irritation, sensitization, acute systemic toxicity; USP Rabbit Pyrogen Study).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."

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

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

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The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia and/or low grade dysplasia) and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit. The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction. There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers (an introducer is a spring that is introduced into the accessory channel port of the endoscope to provide additional strain relief to the catheter during insertion and retraction from the endoscope) in individual pouches. These catheters are used to introduce the liquid nitrogen to the desired site. Additionally, the active venting kit is provided with a carton of five (5) individually packaged sterile, single-use cryo decompression tubes (CDTs) with associated tubing in individual pouches. The CDTs are used for the removal of the gaseous nitrogen from the patient. Each carton within a spray kit contains the instructions for use.

The truFreeze System is a cryosurgical tool validated through a series of non-clinical performance tests. The acceptance criteria and the study results are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test in the "Summary of Non-Clinical Performance Testing." The tests are labeled as "verification testing," which typically involves conducting tests on a representative number of units to ensure consistency and compliance.

The data provenance is from non-clinical testing conducted by STERIS Corporation for a modification to their existing truFreeze System (K222272). This is presumably prospective testing, as it was specifically done to validate the redesigned 16 French (Fr) cryo-decompression tube. The country of origin of the data is not explicitly stated, but given STERIS Corporation's address in Mentor, Ohio, USA, it can be inferred that the testing was conducted in the USA or by labs commissioned by them.

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

This information is not applicable as the described study is a series of non-clinical performance tests, not a clinical study involving human or image-based ground truth established by experts.

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

This information is not applicable for the same reason as point 3. The testing involves objective physical and functional measurements against predefined specifications.

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 applicable. The truFreeze System is a cryosurgical tool, not an AI-assisted diagnostic or imaging device used with human readers.

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

This information is not applicable. The truFreeze System is a physical medical device, not a standalone algorithm.

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

For the non-clinical performance testing, the "ground truth" is defined by engineering specifications, established standards (e.g., ISO-10993 for biocompatibility), and functional requirements derived from the intended use of the device. For example, for "Suction flow rate," the ground truth would be a predetermined flow rate range that the device must achieve.

8. The sample size for the training set:

This information is not applicable. The device is a hardware system, and the reported testing is traditional engineering verification, not machine learning model training.

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

This information is not applicable for the same reason as point 8.

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The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia and/or low grade dysplasia) and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers (an introducer is a spring that is introduced into the accessory channel port of the endoscope to provide additional strain relief to the catheter during insertion and retraction from the endoscope) in individual pouches. These catheters are used to introduce the liquid nitrogen to the desired site.

Additionally, the active venting kit is provided with a carton of five (5) individually packaged sterile, single-use cryo decompression tubes (CDTs) with associated tubing in individual pouches. The CDTs are used for the removal of the gaseous nitrogen from the patient. Each carton within a spray kit contains the instructions for use.

The provided text is a 510(k) Summary for the truFreeze System, which is a cryosurgical tool. This document primarily focuses on demonstrating substantial equivalence to a predicate device and addresses labeling changes, rather than presenting a performance study with acceptance criteria for a new or modified device.

Therefore, most of the requested information regarding acceptance criteria and performance study details is not available in this document. The document explicitly states:

• "No performance testing was conducted as the subject of this submission is changes to the labeling only."

This means there is no study described that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a new device. The submission is for administrative and labeling changes.

However, I can extract information related to the device's characteristics and the basis for its substantial equivalence, which implicitly indicates its expected performance based on the predicate device.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as "acceptance criteria" for a new performance study. However, the "Technological Characteristics Comparison Table" (Table 1 on page 5) lists performance specifications that the device is expected to meet because it's identical to the predicate device. These characteristics essentially serve as the "performance" assumed to be met.
• Reported Device Performance: The document states the device's characteristics are "Identical" to the predicate, K171626. Therefore, the performance values are the same as those established for the predicate device.

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

• Not applicable / Not provided. The document states "No performance testing was conducted." Therefore, there is no test set, sample size, or data provenance from a new study to report.

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 / Not provided. No new performance study was conducted that would require expert-established ground truth.

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

• Not applicable / Not provided. No new performance study was conducted.

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 / Not provided. This device is a cryosurgical tool, not an AI/imaging diagnostic device. No MRMC study was mentioned or performed for this submission.

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

• Not applicable / Not provided. This is a hardware device, not an algorithm. No standalone algorithm performance was assessed for this submission.

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

• Not applicable / Not provided. No new performance study requiring ground truth establishment was conducted for this submission. The basis for safety and effectiveness is substantial equivalence to the predicate device, which would have had its performance and safety established through prior testing and clinical use.

8. The sample size for the training set

• Not applicable / Not provided. No machine learning or AI model development is described, so there is no training set mentioned.

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

• Not applicable / Not provided. No machine learning or AI model development is described, so there is no training set or ground truth establishment for it.

In summary, this 510(k) submission is for administrative and labeling changes for a cryosurgical system and explicitly states that no new performance testing was conducted. Therefore, the detailed information about acceptance criteria, study design, and ground truth establishment requested for a performance study is not available within the provided document. The device's performance is assumed to be identical to its predicate, K171626, based on the lack of changes affecting performance.

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Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

Dentilube dry mouth spray is a viscous pink electrolyte-containing solution that is designed to mimic the compositions and actions of saliva to moisturize, and refresh the mouth. It provides a lubricating and moisturizing coating inside the mouth, thereby relieving symptoms of dry mouth. The product is supplied in 50mL or 100 mL PET bottles.

The provided text describes the acceptance criteria and performance data for the Dentilube dry mouth spray (K202689). The study is a non-clinical performance test to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers or a standalone algorithm performance study.

Here's the breakdown of the requested information:

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

The acceptance criteria are implicitly defined by demonstrating "similarity" or "sameness" to the predicate device, BioXtra® Moisturizing Gel (K072306), across various attributes and physical properties. The performance is reported against these comparative attributes.

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

The document does not detail a specific "test set" in the context of a clinical study with human subjects. The performance testing described is primarily non-clinical performance testing (e.g., pH, viscosity, specific gravity, shelf-life, biocompatibility). It aims to demonstrate that the physical and chemical properties of the device are substantially equivalent to the predicate device. Therefore, a sample size for a clinical test set is not applicable here.

The data provenance is not specified beyond being generated by Oxy2plus, LLC for the purpose of this 510(k) submission.

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. This is not a study involving expert assessment of images or clinical outcomes. The "ground truth" for the non-clinical tests are standard physical and chemical measurements (e.g., pH meter readings, viscometer readings).

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

Not applicable. No expert adjudication process is described as this is a non-clinical, comparative assessment of product characteristics.

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. This document describes a medical device (dry mouth spray), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

No. This is a physical product, not an algorithm.

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

For the non-clinical performance tests:

• Physical Property Measurements: The ground truth for properties like pH, viscosity, specific gravity, and solubility are the direct measurements obtained through standard laboratory instruments and methods.
• Shelf-Life/Stability: Determined by degradation studies over time.
• Biocompatibility: Determined by adherence to ISO 10993 standards (e.g., cytotoxicity assays, sensitization studies, irritation tests).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

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Dentsply Sirona Universal Spray Glazes are aerosol glazing porcelains used to glaze high-strength glass ceramic and zirconia dental restorations. The glaze sprays are applied to restorations and fired.

The proposed devices, Dentsply Sirona Universal Spray Glazes are sprayable glazing porcelains, intended for glazing the surface of dental restorations. The glazes are supplied to dental professionals in an aerosol can. Different variations of glazes are available to meet the aesthetic preferences of dental professionals and patients. Variations with or without fluorescing agent come in a ready-to-use spray can. Variations are distinguished by the names, "Fluo" or "No Fluo" to designate the presence of fluorescing agents in the product.

No mixing is required by dental professionals as different glaze options (with or without fluorescing agent) are supplied to dental professionals in a ready-to-use form. The addition of the fluorescing agent contributes to a more aesthetic natural looking restoration.

The proposed devices, Dentsply Sirona Universal Spray Glazes, are applied on the surface of the dental restoration (example: fixed dental prostheses such as crown or bridge) in a thinuniform layer. After initial application, the restoration is then fired in a furnace for further processing. An additional layer of the proposed Dentsply Sirona Universal Spray Glazes can be applied after first firing, if necessary. If additional layer is applied, the dental restoration is placed again in the dental furnace for final firing.

This document is a 510(k) Premarket Notification for Dentsply Sirona Universal Spray Glazes. It focuses on demonstrating substantial equivalence to a predicate device, CEREC SpeedGlaze (K160099), for dental glazing purposes. The provided information does not describe a study that uses an AI/ML algorithm or requires a detailed ground truth establishment process involving multiple experts.

The acceptance criteria provided and the study conducted are for a physical material (dental glaze), not an AI/ML device. Therefore, many of the requested bullet points for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the relevant information from the document regarding the acceptance criteria and the performance study undertaken for this dental glaze product.

Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:

Device Name: Dentsply Sirona Universal Spray Glazes

Device Type: Aerosol glazing porcelains for dental restorations (a physical material, not an AI/ML device).

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

The acceptance criteria are derived from the ISO 6872:2015 - Dentistry - Ceramic materials standard for Type I Class 1 materials. The reported device performance is stated as meeting these criteria.

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Intended Use: The truFreeze® System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C, requiring either active or passive venting during surgical procedures.

Indications for Use. VortexTM Radial Spray catheter: The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.

The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus.

The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube.

The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.

The provided text is a 510(k) Premarket Notification for the CSA Medical, Inc. truFreeze® System, specifically the Vortex™ Radial Spray Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device (K171626) by comparing technological characteristics and presenting performance testing results.

Crucially, this document does not contain a typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the format of a clinical trial designed with defined endpoints (like sensitivity, specificity, accuracy) for a diagnostic AI device.

Instead, this submission is for a cryosurgical treatment device, not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating the device's safety and effectiveness compared to a predicate device that performs a similar function.

Based on the provided text, here's an attempt to extract relevant information, adapting to the nature of the device:

1. Table of "Acceptance Criteria" (interpreted as performance specifications/comparisons to predicate) and Reported Device Performance:

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

• Bench Tests: "A number of bench tests were conducted to verify the product design met the predetermined product performance specifications." No specific sample sizes for these tests are mentioned.
• Pre-clinical (GLP Studies): "Three preclinical GLP studies were completed utilizing the Vortex™ Radial Spray catheter in swine." The exact number of swine used is not specified, only the number of studies.
• Clinical Data (Literature/RWD for Predicate Device):
  • Literature: "Three scientific, peer-reviewed literature articles have been published demonstrating the ability of the predicate device (i.e. linear spray) to achieve circumferential freezing of diseased tissue in the esophagus."
  • Patient Count from Literature: "73 patients have been treated with spray LN2 circumferentially since 2012 to ablate BE lesions."
  • Real-World Data (RWD) from Registry: "Real-World Data (RWD) has been extracted from an ongoing prospective, multi-center patient registry."
  • Patient Count from RWD: "Of the 112 patients identified in the registry as having Barrett's Esophagus, 49 of those patients received circumferential ablation."
  • Provenance: No specific country of origin is mentioned for the literature or RWD, but it can be inferred to be from regions where such studies are conducted (likely US/Europe). The RWD is "prospective, multi-center."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable in the context of this submission. This is not an AI diagnostic device requiring expert reading for ground truth establishment. The "ground truth" for this device's performance would be direct measurements (e.g., cooling power, depth of freeze in hydrogel) and histological assessment in animal models. Clinical outcomes cited from literature/RWD would be physician-documented.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert readings from a test set.

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

No. This type of study (MRMC) is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a medical device that performs a physical ablation.

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

Not applicable. This is a physical medical device, not an algorithm. Bench and preclinical data are provided for the device's standalone physical performance.

7. The Type of Ground Truth Used:

• Bench Testing: Engineering specifications and direct physical measurements (e.g., temperature, power density, dimensional measurements).
• Pre-clinical (Swine Studies): Histopathology data (e.g., assessment of lesion size, depth of injury) and survival/adverse event data.
• Clinical Data (from Literature/RWD for predicate): Clinical outcomes (ablation endpoint, adverse events like stricture), and physician observations.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device with a distinct training set. The "training" in this context refers to the development and iterative testing of the device throughout its design process.

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

Not applicable for the reasons stated above.

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Use as needed for instant relief. OraLabs Dry Mouth Pocket Spray helps maintain the oral environment and helps provide protection against dry mouth symptoms.

OraLabs Dry Mouth Pocket Spray is a specially formulated water soluble artificial saliva substitute with a pH between 5.20 to 7.20 for use at home in the oral cavity. OraLabs manufactures the products in a 0.25 FL OZ polyethylene bottle with a non-aerosol pump. The formula contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.

This document describes the premarket notification for OraLabs Dry Mouth Pocket Spray, and outlines its substantial equivalence to the predicate device, Biotene Moisturizing Mouth Spray. It is important to note that this document pertains to a device that delivers a substance (dry mouth spray) and not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, the questions related to AI/ML specific criteria (e.g., ground truth establishment for training sets, MRMC studies, AI assistance effect size) are not applicable to this submission.

Here's a breakdown of the information provided, addressing the applicable questions:

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

The document does not explicitly present "acceptance criteria" in a typical tabular format with pass/fail metrics. Instead, it describes performance testing conducted to demonstrate "substantial equivalence" to the predicate device. The performance data presented below indicates comparative results used to support this claim, rather than pre-defined acceptance thresholds.

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

The document does not specify sample sizes for most of the performance tests (e.g., pH, viscosity, moisture deabsorption, appearance, sensory properties, elemental impurity).

For biocompatibility testing, it's implied that individual samples of both OraLabs and Biotene products were tested. The specific number of replicates/samples for cytotoxicity, sensitization, and irritation is not stated.

For stability testing, the product was filled into "individual spray bottles," and tested at Baseline, 3 months, and 6 months intervals. The exact number of bottles/samples tested at each interval is not specified.

The data provenance is from OraLabs, Inc. (Parker, Colorado, USA) and is prospective as it involves the testing of their new device.

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

This question is not applicable. This is a medical device (a spray product), not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for this type of device is established through physical and chemical property testing, and comparison to a legally marketed predicate device.

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

This question is not applicable. There were no human expert adjudications for the test results of this product. The evaluation relies on laboratory test results.

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 question is not applicable. This is not an AI/ML powered device, and therefore no MRMC study involving human readers or AI assistance was conducted.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no standalone algorithm performance was assessed.

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

The "ground truth" for mechanical/chemical performance was established through laboratory testing (e.g., pH meters, viscometers, chemical analysis, microbiological assays, biocompatibility assays). For the purpose of regulatory clearance, the implicit ground truth is that the device should demonstrate substantially equivalent performance characteristics to the legally marketed predicate device (Biotene Moisturizing Mouth Spray) in terms of safety and basic functionality.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML powered device, and therefore no training set was used.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no training set or its ground truth were established.

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Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Gebauer's Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deliver ethyl chloride in a mist, fine or medium spray. This chemical self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device is packaged in either a pharmaceutical glass bottle or steel aerosol can with several variations of nozzles. The patient contact is less than ten seconds and the skin is cooled through rapid evaporation of the non-medicated volatile propellant.

The provided text describes a 510(k) premarket notification for "Gebauer's Ethyl Chloride Topical Anesthetic Spray", asserting its substantial equivalence to a predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing new acceptance criteria or proving efficacy through clinical studies as would be done for a novel device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on demonstrating equivalence through comparison of technical characteristics and existing test data for the predicate device, along with specific testing related to labeling changes.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not present in a 510(k) submission of this nature:

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

The document does not specify quantitative "acceptance criteria" in the typical sense of a clinical trial (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing the new device has the same technological characteristics and similar indications for use as the predicate device, and that specific tests for labeling changes were met.

Therefore, a table of acceptance criteria and reported device performance directly addressing efficacy is not presented. The performance is summarized by demonstrating no impact on the device's function or safety due to minor changes.

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: The document does not specify a "test set" sample size in terms of patient numbers or a large dataset. The "tests" mentioned (Biocompatibility, USP ) are laboratory-based and generally involve material samples or microbiological cultures, not human or large-scale clinical test sets.
• Data Provenance: Not specified, as these are laboratory tests rather than clinical data from a specific country or collected retrospectively/prospectively from patients.

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 applicable to the type of device and tests described. The tests performed (Biocompatibility, USP ) are standardized laboratory tests, not subjective interpretations requiring multiple human experts to establish ground truth.

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

Not applicable. Adjudication methods are typically employed in clinical studies where multiple readers interpret results, which is not the case for the laboratory tests performed here.

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 device is a topical anesthetic spray, not an AI-powered diagnostic system, thus MRMC studies, AI assistance, or human reader improvement are irrelevant to its evaluation.

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

Not applicable. This device is a medical device, not an algorithm.

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

For the tests mentioned:

• Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and the absence of specific adverse biological reactions (cytotoxicity, sensitization, irritation) in validated test models.
• USP Antimicrobial Effectiveness Testing: Ground truth is defined by the pharmacopeial standard (USP ) which sets specific log reduction targets for microorganisms after inoculation over time.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

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

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

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