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The DentalJect™ is intended for topical application to intact mucous membrane (oral cavity). The DentalJect™ is used to target a minimally sized cooling area for lessening pain associated with injections.

The DentalJect™ is a prescription device which attaches to a standard dental syringe and dispenses a non-medicated, non-flammable vapocoolant blend as a topical anesthetic for intact oral mucosa.
Pressurized dispensing container, which includes the vapocoolant, canister and valve; Syringe barrel attachment Dental Connector; and DentalJect™ accessory nozzle (actuator).

This FDA approval letter for the DentalJect device (K243654) does not contain sufficient information to fully complete all sections of your request regarding acceptance criteria and the study proving the device meets those criteria. The letter emphasizes non-clinical testing and substantial equivalence rather than detailed clinical performance studies with specific statistical acceptance criteria for efficacy.

However, based on the provided text, I can extract the following information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document describes several non-clinical tests but does not explicitly state quantitative acceptance criteria for device performance with numerical targets and reported results in the same way a clinical trial might for sensitivity/specificity. Instead, it states that tests were performed "to ensure the subject device, DentalJect™, met predefined requirements pertaining to fit, form and safe function" and that "All of the results successfully met the test criteria."

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

The document does not explicitly state the sample sizes for the "test sets" or the data provenance (e.g., country of origin, retrospective/prospective) for any of its non-clinical tests. It implies that "user groups" were involved in usability testing and that standard bench tests were conducted.

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

Not applicable. The reported studies are non-clinical (bench testing, biocompatibility, usability), not clinical trials requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring adjudication in the provided text.

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

No, an MRMC comparative effectiveness study was not done. The document states "Clinical Testing: Not Applicable."

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

Not applicable. The DentalJect is a physical device (vapocoolant dispenser), not an algorithm or AI software for which standalone performance would be relevant.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was based on established industry standards and regulatory test criteria (e.g., ISO 10993 series for biocompatibility, CFR for flammability, predefined specifications for fit/form). There is no mention of pathology, outcomes data, or expert consensus as would be used in a diagnostic clinical study.

8. The Sample Size for the Training Set:

Not applicable. As a physical device rather than an AI/ML algorithm, there is no "training set" in the context of machine learning.

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

Not applicable, for the same reason as point 8.

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PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical op skin. intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

The Subject Device consists of a chemical blend of 60% HFO-1233zd (Trans-1-chloro-3.3.3- trifluoropropene) and 40% HFO-1234ze (trans- 1.3.3.3-tetrafluoroprop-1- ene) that produces a cooling effect upon contact with the skin, intact mucous membranes, and minor open wounds. The product is delivered in the form of an aerosol in either a mist or stream spray. The device's delivery system controls the amount of chemical blend that is dispensed, the mist spray configuration produces very fine droplets that cools at the points of contact. The stream spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Upon contact with the skin, the product begins to evaporate immediately as it contacts the skin. The low evaporation rate of the product's chemical blend is what creates the coldness. The Subject Device is non- flammable and has a lower global warming potential than the predicate and provides equivalent performance.

The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface.

With both product configurations, the evaporation creates the cold sensation. As the distance from the target surface is increased, the dispersion of the droplets in both the mist and stream is increased. Increasing the surface area of contact and decreasing the size of the droplets increases the evaporation rate. The increase in evaporation rate correlates to an increase in the cooling effect.

The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.

The provided document is an FDA 510(k) Premarket Notification clearance letter for a medical device called "PainFreeze II," which is a vapocoolant (skin refrigerant). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced clinical effectiveness or accuracy via a traditional clinical trial or performance study typical for diagnostic/AI devices.

Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies that would be present for a diagnostic device or an AI/ML algorithm. The "performance" being assessed here is primarily related to safety, physical characteristics, and equivalence to a predicate, not diagnostic accuracy or clinical outcome improvement.

Based on the provided text, here's what can be extracted and what is not available:

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

The document describes non-clinical testing performed to demonstrate that the device is similar to its predicate and meets safety/performance requirements. The "criteria" are implied by the successful meeting of test requirements for each evaluation.

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The CRYO Penguin is indicated for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sports injuries and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

The CRYO Penguin utilizes liquid nitrogen (LN2) to provide supercooled air for localized treatment. There are three main components to the device: Liquid nitrogen vessel with an evaporator, Cryogenic hose with a treatment handle, Electrical box and HMI panel with control software. The CRYO Penguin directs cold gas to the treatment area via a cryogenic hose tipped with a treatment handle. The handle is equipped with a red laser and LED lights to accurately position the treatment handle to provide a readout of the patient's skin temperature. The treatment handle does not physically touch the patient. To assure that the wand maintains the proper distance to the patient (approximately 15cm), there are two small lasers which provide two laser dots. When these dots converge to one dot, the handle is properly distanced. If the handle moves closer to the patient or further away, the dots no longer converge, providing a visual cue to the operator that the handle position has changed and is no longer optimal. Additionally, a temperature sensor and LED lights monitor optimal skin surface temperature; LED lights indicate skin temperature status as follows: GREEN the skin temperature is too high for optimum treatment (above 4°C) and should be further cooled. BLUE - the skin temperature is at the desired temperature (in the range of 2-4℃). RED the skin temperature is too low (below 2°C), and the treatment handle is removed or moved further away from the patient. If the temperature of the skin surface is below -1ºC for 1 second, auto-off function activates. The CRYO Penquin is software driven via pre-programmed protocol. Treatment time is monitored via countdown timer which is adjustable based on the treatment desired. Note: The protocol is selected prior to the session and may not be changed during the session. The CRYO Penquin may only be operated by a trained and authorized person.

Here's a breakdown of the acceptance criteria and the study information for the CRYO Penguin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 3 human subjects.
• Data Provenance: Not explicitly stated, but the testing was "non-clinical" and likely conducted in a controlled environment, specific to the device manufacturer (CryoScience North America, Inc.). It's a prospective study conducted specifically for this submission.

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

• This information is not provided in the document. The "Verification Testing" involves measuring skin temperature and observing LED light behavior, which is objective and doesn't explicitly mention expert arbitration for ground truth.

4. Adjudication Method for the Test Set

• This information is not provided. The "Verification Testing" described is objective measurement rather than subjective evaluation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not conducted and is not mentioned in the document.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

• Yes, the performance data provided appears to be a standalone (algorithm/device only) study. The "Verification Testing" for skin temperature and LED indicator accuracy directly assesses the device's functional performance independently. There is no mention of human-in-the-loop performance measurement.

7. The Type of Ground Truth Used

• The ground truth for the device's performance (specifically the skin temperature and LED indicator accuracy) was established through direct physical measurement (e.g., of skin temperature) and functional observation of the device's output (LED lights). For electrical safety, EMC, and software, the ground truth is adherence to established international standards (IEC 60601-1, IEC 60601-1-2, IEC 62304) and FDA guidance.

8. The Sample Size for the Training Set

• This information is not provided as the document discusses verification testing for the device's operation, not an AI/machine learning model that would typically have a "training set." The software validation mentioned refers to software verification and validation, not model training.

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

• This information is not applicable/not provided as there is no mention of an AI/machine learning model with a "training set" in the context of this device's submission. The "software" mentioned refers to the device's control software, which is validated against its specifications and relevant standards, not "trained" in the typical ML sense.

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nüm is a sterile topical anesthetic spray - vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries.

num Vapocoolant is a sterile-fluid-path, single-use, prescription device that delivers a vapocoolant mixture of 95% r254fa (1,1,1,3,3-Pentafluoropropane) and 5% 134a (1,1,1,2-Tetrafluoroethane). The vapocoolant is stored in a sealed canister within the Main Body of the device. When dispensed from the canister, this mixture self-propels itself from the delivery system using its vapor pressure as propellant leaving the device exits through the Nozzle which is engineered to produce a mist spray. When the vapocoolant reaches the skin, cooling achieved through rapid evaporation of the non-medicated volatile products, and through the cooling capacity of the low-temperature evaporating vapocoolant. Device sterility is achieved through electron beam sterilization and maintained through protective Tyvek lidstock on the top of the nozzle, and a Cap in the base of the Main Body.

The provided text describes the 510(k) premarket notification for the "num Vapocoolant™" device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance "acceptance criteria" and a "study" in the traditional sense of a clinical trial proving performance against those criteria. In 510(k) submissions for devices like this vapocoolant, the "acceptance criteria" are implicitly met by demonstrating equivalence to a legally marketed predicate device, especially for unclassified devices.

The "study" here is a series of non-clinical tests and comparisons to establish this substantial equivalence. There is no information about an AI/ML component, human readers, expert consensus for ground truth on patient data, MRMC studies, or training/test sets as these concepts typically apply to AI/ML device evaluations.

Therefore, the response below will interpret "acceptance criteria" in the context of a 510(k) submission for a non-AI/ML device seeking substantial equivalence, and the "study" as the set of non-clinical tests and comparisons performed.

Acceptance Criteria and Device Performance for num Vapocoolant™

For the num Vapocoolant™ device, the "acceptance criteria" are implicitly met by demonstrating Substantial Equivalence (SE) to a legally marketed predicate device, Gebauer's Skin Refrigerant. The performance criteria for such a device largely revolve around safety, the intended mechanism of action (cooling through rapid evaporation), and equivalence in composition and application compared to the predicate. The "study" proving acceptance is the detailed comparison and non-clinical testing outlined in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Differences and Assessment:

• num is a sterile, single-dose container; predicate is non-sterile, multi-dose.
• Assessment: Sterilization does not alter chemistry of volatiles. The single-dose design of num still produces an equivalent cooling effect when used as per IFU. These differences do not raise new safety or effectiveness questions. |
  | Biocompatibility | Acceptable biological risk for patient contact. | Demonstrated compliance with ISO 10993, including Cytotoxicity and Sensitization testing. This established acceptable biological risk. |
  | Sterilization (if applicable) | Validated sterilization process and maintenance of sterility. | num Vapocoolant™ is sterile (SAL 10⁻⁶) via radiation, validated per ISO 11137 series. This differs from the predicate (non-sterile), but the vapocoolant chemistry is unaltered by sterilization. |
  | Performance Testing (Mechanism & Delivery) | Ensures safety, reliability, and efficacy of product delivery and function, similar to predicate. | Non-clinical performance tests included: Device sterility, Sterile barrier efficacy, Sterile barrier usability, Actuation force, Vapocoolant performance, and Spray Production and Duration. These tests would ensure the device consistently delivers the vapocoolant as intended. |
  | Environmental Compatibility | Non-flammable. | Both devices are Non-Flammable. |

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

This 510(k) submission does not involve a "test set" in the context of an AI/ML device evaluated on patient data. The "tests" here are non-clinical, laboratory-based evaluations of the device's physical and chemical properties and performance characteristics, as well as a direct comparison to a predicate device. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.

3. Number of Experts and Qualifications for Ground Truth

This submission does not mention the use of experts to establish "ground truth" for a test set of patient data, as it is not an AI/ML device evaluating medical images or patient outcomes. The determination of substantial equivalence is made by the FDA based on the submission's evidence, often relying on established standards and testing protocols rather than multi-expert consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of patient cases requiring adjudication by multiple readers or experts.

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

Not applicable. This device is a vapocoolant spray and not an AI/ML diagnostic or assistive tool where human reader performance would be measured with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Not applicable, as this device is a physical medical device (vapocoolant spray), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established by demonstrated compliance with recognized standards and direct comparison to a legally marketed predicate device.

• Predicate Equivalence: The primary "ground truth" is the established safety and effectiveness of the predicate device (Gebauer's Skin Refrigerant), which the num Vapocoolant™ aims to be substantially equivalent to.
• Non-clinical Test Standards: "Ground truth" for specific parameters (e.g., biocompatibility, sterilization, spray performance) is derived from ISO 10993 (biocompatibility), ISO 11137 series (sterilization), and other implicit engineering and performance standards for medical spray devices.

8. Sample Size for the Training Set

Not applicable. The described device is a physical product, not an AI/ML algorithm that requires a training set.

9. How 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 Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions)

The Syringe Holder accessory is intended to be attached to the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.

The Syringe Holder accessory (K201248) on the Nozzle of the Primary predicate Vapocoolshot Mist (K193349), allows the attachment of a user supplied syringe diameter 1cc (4.5mm) to 3 cc (10.8mm) for the practitioner to focus on the transient blanching effect for the best rapid, targeted, comfortable and efficient use of the gas Blend misting action onto the skin surface accordance with the best judgment of the physician under aseptic conditions. The Primary predicate Vapocoolshot Mist (K193349) is a vapocoolant (skin refrigerant) canister with standard gas Blend 245fa (1,1,3,3 Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane) that is designed to spray onto the skin surface for a comfort injection procedure. The vapocoolant cools the skin through rapid evaporation of the non-medicated propellants.

The subject device, Syringe Holder accessory (K201248) helps direct the site with the following efficient use of the gas Blend with the syringe: configures refrigerant gas to a mist, targets the transient blanche site, one handed use, keeps the syringe in the same path, and controls the amount of the vapocoolant mixture that is dispensed for the practitioner. Thus, the accessory device avoids over spraying and having to switch from a canister spray effect to a syringe injection technique that may have dissipated the transient numbing effect for comfort results.

This FDA 510(k) summary describes a premarket notification for a Syringe Holder accessory (VM03000). The document aims to demonstrate that this accessory, when used with the Vapocoolshot Mist (primary predicate), is substantially equivalent to an existing predicate device called "Ouchless".

It is crucial to understand that this document does not describe an AI medical device or a study involving an algorithm's performance. The device in question is a physical accessory for a medical tool, not a software or AI product. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable to this submission.

Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations for an AI-centric request:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for performance metrics (like sensitivity, specificity, accuracy). Instead, substantial equivalence is established by comparing technological characteristics and intended use. The "performance" described is about meeting the functional criteria set by the predicate device and being safe and effective.

• Type (Rx)
• Attaches a syringe (Yes)
• Same Technology (Yes)
• Syringe controlled by Practitioner (Yes)
• Drug controlled by Practitioner (Yes)
  Differences noted:
• Subject device attaches to a syringe by "one device," while predicate 1 attaches based on "3 colors." This difference is not deemed to raise new questions of safety or efficacy.
• Design as a unit: Subject device is the accessory itself; Primary Predicate is the pressurized dispensing container. Predicate 1 includes the container, valve, and syringe attachment. The Syringe Holder accessory (subject device) combined with the Primary Predicate (Vapocoolshot Mist) forms a unit with similar technological characteristics to Predicate 1 (Ouchless). |
  | Biocompatibility | Materials must be biocompatible. | The subject accessory device has no contact with the gas Blend or the patient, and its materials are reported as biocompatible. |
  | Chemical Composition| Material composition must be consistent and verified. | The subject device's material is checked and verified upon receipt from the supplier to ensure the same chemical profile. |
  | Structural Integrity| Must be equivalent to the predicate device(s). | Engineering verification measurements were taken, and visual inspections were made to determine the Syringe Holder accessory (K201248) when used with the Primary predicate were equivalent to the Predicate 1 (Ouchless). |
  | Directions for Use (DFU) | Must be substantially equivalent. | All key elements of the DFU between Predicate 1 and the subject device accessory attached to Primary predicate as a unit are similar. No significant differences exist. |
  | Safety and Effectiveness | Must be safe and effective for its intended use, not raising new questions compared to predicates. | Based on the performance evaluations conducted (usability study, biocompatibility, chemical composition, structural integrity, DFU comparison, bench testing), the Syringe Holder Accessory (K201248) when used with the Primary Predicate Vapocoolshot Mist (K193349) were found to be safe and effective to the Predicate 1 (Ouchless). It does not raise additional questions of safety, efficacy, and effectiveness different from the Predicate (Ouchless). |

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

• Test Set Sample Size: The document mentions a "Usability study was performed" and "Comparative performance testing was conducted." However, no specific sample sizes (e.g., number of participants, number of devices tested, number of observations) are provided for any of the performance evaluations.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the "bench testing" and "usability study" mentioned, it would typically be prospective, internally conducted testing, but this is not explicitly stated.

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 to a physical medical device accessory that is undergoing a substantial equivalence review. There is no "ground truth" establishment in the context of an AI algorithm's performance review. The evaluations are against engineering specifications, biocompatibility, and functional equivalence to a predicate device.

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

Not applicable. This is not a study requiring adjudication of diagnostic results or interpretations.

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 device or a diagnostic imaging study.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. As noted in #3, there is no "ground truth" in the AI/diagnosis sense. The "ground truth" for this device's performance would be engineering specifications, material standards, and the functional characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve a "training set" or "ground truth" in the machine learning sense.

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The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions).

The Vapocoolshot Mist is a Vapocoolant (skin refrigerant) canister with an accessory nozzle that is intended for instant topical anesthetic. The Vapocoolshot Mist allows for the ease of use for a rapid, targeted, comfortable misting action of the refrigerant (cold like ice) onto the skin surface. Vapocoolshot Mist is prescription device designed to deliver a standard mixture 245fa (1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) mist spray that will provide a transient refrigerant action. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The Vapocoolshot's nozzle, device's delivery system, controls the amount of the vapocoolant mixture that is dispensed. The mist spray configuration produces very fine droplets that create cooling at the points of contact. The Vapocoolshot produces a mist that contacts the skin surface at a targeted location. The skin is cooled through rapid evaporation of the non-medicated propellants.

This document describes a 510(k) submission for the Vapocoolshot Mist, a topical refrigerant. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily "Gebauer's Pain Ease" (K172028) and "Ouchless" (K093951).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on comparative equivalence to predicate devices across various characteristics. The "reported device performance" is framed as demonstrating similarity or equivalence.

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

The document does not explicitly state sample sizes for specific test sets in a numerical fashion (e.g., number of patients or devices tested). Instead, it refers to "engineering verification measurements" and "comparative performance testing."

• Sample Size: Not specified quantitatively.
• Data Provenance: The studies appear to be retrospective bench testing and engineering comparisons rather than prospective clinical trials with human subjects. The details about data origin (e.g., country) are not provided, but given the submission is to the FDA, it is implied to be relevant to U.S. regulatory standards.

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

The document does not mention the use of experts to establish "ground truth" in the context of clinical outcomes or diagnostic accuracy. The testing performed is focused on comparative engineering and chemical composition, for which ground truth is established by measurement and analytical methods, not typically by expert consensus of a specific number of clinicians.

4. Adjudication Method for the Test Set

Not applicable. The reported studies are bench tests and engineering comparisons, not studies requiring adjudication of clinical or diagnostic outcomes by experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the nature of this device or its reported testing.

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

Not applicable. The Vapocoolshot Mist is a physical device that delivers a topical refrigerant, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Chemical Analysis: Chromatographic or other analytical methods to determine the exact composition of the vapocoolant.
• Engineering Specifications and Measurements: Physical measurements of device components, discharge characteristics (temperature, volume), and adherence to design specifications.
• Regulatory Standards: Compliance with established safety and efficacy standards for medical devices and comparison to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product, 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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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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Coventry ™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Coventry ™ controls pain associated with injections (venipuncture, IV starts, cosmetic procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Coventy ™ Medium Stream Spray is also intended for use the management of myofascial pain, restricted motion and muscle tension.

Coventry™ Topical Anesthetic Spray HAZMAT FREE (subject device) is a non prescription device designed to deliver a standard mixture (1,1,1,3,3-245fa Pentafluoropane) and 134a (1.1.1.2-Tetrafluoroethane). which is being offered in two delivery configurations, Mist Spray Model No. 700-453 and Medium Stream Spray Model Number 700-454 This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the Coventry "" mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Medium Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device called "Coventry Topical Anesthetic Mist/Stream Spray HAZMAT FREE". This notification is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the document primarily focuses on comparing the subject device to its predicate, rather than providing a detailed study of the subject device against specific acceptance criteria for a novel device.

However, based on the provided text, I can extract information related to the demonstration of substantial equivalence, which serves as the "study" in this context.

Here's a breakdown of the requested information based on the document:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics. Instead, "performance" is demonstrated through the similarity to the predicate device. The acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device, demonstrated by having similar technological characteristics, indications for use, and a similar safety and effectiveness profile.

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 specify a "test set" in the traditional sense of a clinical trial with human subjects. The evidence for substantial equivalence primarily relies on comparative technical testing and verification of manufacturing parameters against the predicate device. Therefore, explicit sample sizes for a patient test set are not provided because a clinical study of that nature was not required for this 510(k) submission.

• Data Provenance: The tests mentioned (Chemical Composition Confirmation, Structural and Parts Composition, Stability Protocol and Shelf Life Testing) were performed by the manufacturer, ITW Contamination Control Electronics. The location is Marietta, GA 30152, USA. The nature of these tests suggests they are prospective for the subject device.

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

Not applicable for this type of 510(k) submission. The ground truth for this submission is the established safety and effectiveness of the predicate device, and the technical performance and composition of the subject device aligning with that. There's no mention of expert review of a "test set" in the context of clinical outcomes to establish ground truth.

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

Not applicable, as a clinical "test set" requiring adjudication of outcomes is not described in the document for this 510(k) clearance.

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 or assistive technology.

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

Not applicable. This device is a physical product (anesthetic spray), not an algorithm or AI.

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

The "ground truth" for this 510(k) is the established performance and safety profile of the predicate device, Gebauer's Pain Ease. The subject device is deemed substantially equivalent because its technical characteristics, formulation, indications for use, and manufacturing controls are identical or sufficiently similar such that it performs in the same way and raises no new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning. The "training" in manufacturing would involve process validation, which is implicitly covered by quality systems and the stability protocol.

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

Not applicable, as there is no "training set" in the context of machine learning for this device.

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Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, mucous membranes and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Gebauer's Pain Ease (Mist and Medium Spray) Topical Anesthetic Skin Refrigerant is a prescription device designed to deliver HFC 245fa high purity (1,1,1,3,3-Pentafluoropropane) and HFC 134a pharmaceutical grade (1,1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system. which is designed to account for its low vapor pressure. The device delivery system is specifically designed to deliver a medium and mist spray of the Gebauer's Pain Ease (Mist Spray and Stream Spray) mixture. The medium and mist spray is an appropriate mode of application when users follow directions for use, cooling the skin through rapid evaporation of the non-medicated volatile propellants. The new device, Gebauer's Pain Ease, is identical in all aspects to the predicate device, Gebauer's Pain Ease (Mist Spray and Medium Spray) 510(k) K032671, except that the product can be applied to the skin for pre-injection anesthesia by cotton swab or gauze on intact skin. (If the skin is breached use this application method only with STERILE, disposable cotton balls, cotton swabs or gauze. The cotton balls, cotton swabs or gauze are not supplied with the device.)

The provided document is a 510(k) premarket notification for a medical device called "Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)." The purpose of the submission is to expand the approved application methods for the device. The document claims substantial equivalence to a previously cleared predicate device (K032671).

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

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance metrics. Instead, it aims to demonstrate substantial equivalence to a predicate device. The performance is assessed by comparing key characteristics of the subject device (Gebauer's Pain Ease with expanded application methods) to the predicate device (Gebauer's Pain Ease, K032671).

The core "performance" reported is related to temperature and output, specifically that the subject device's profile is "similar" to the predicate.

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

The document states: "Comparative testing was conducted to demonstrate equivalence between direct topical application via spraying and topical application using cotton ball, cotton swab or gauze." It refers to this as "Side-by-Side Temperature & Output Bench Testing."

• Sample Size: The document does not specify the sample size for this bench testing. It simply states "tests were selected and performed."
• Data Provenance: The data is from bench testing, meaning it was conducted in a controlled laboratory environment to compare the physical characteristics of the devices. No information is provided regarding the country of origin, nor whether it was retrospective or prospective in the clinical sense, as it was a bench study.

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 study described is a bench test comparison of physical parameters (temperature and output), not a clinical study involving human assessment or expert judgment to establish a "ground truth" for a medical condition.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. There was no "ground truth" adjudicated by experts for a clinical outcome.

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

There was no MRMC comparative effectiveness study done. This is a 510(k) submission for a topical anesthetic, not an AI-assisted diagnostic device.

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

This is not applicable. The device is a physical product (vapocoolant spray), not an algorithm or AI system.

7. The type of ground truth used

As this was a bench test comparing physical characteristics, the "ground truth" was essentially instrumental measurements of temperature and output. There was no expert consensus, pathology, or outcomes data used to establish a ground truth for a disease or condition.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.

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

This is not applicable as there is no training set.

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Mist Spray:
CryoDose TA OTC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.

Stream Spray:
CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.

Nuance Medical's CryoDose TAOTC (subject device) is an over-the-counter (OTC) device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 1815) and Stream Spray (Model No. 1821). This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the CryoDose TA TTC mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.

This document is a 510(k) Summary for the CryoDose TA OTC (Mist Spray and Stream Spray) device, which is a vapocoolant for temporary pain relief. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested categories related to AI/software performance studies (like sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the device's characteristics and the types of tests performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on a physical medical device (vapocoolant spray) and not an AI/software product, the "acceptance criteria" are related to demonstrating similarity to a predicate device rather than numerical performance thresholds for diagnostic accuracy. The "reported device performance" is essentially that the device was found to be "substantially equivalent" and met the requirements outlined for physical and chemical characteristics.

2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a "test set" of medical images or patient data for an AI/software device. The testing involved laboratory and bench testing of the physical properties and chemical composition of the device, utilizing data from an identical reference device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study assessing diagnostic performance against a ground truth established by experts.

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 device is a vapocoolant spray, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a vapocoolant spray.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the "ground truth" was the established standards and acceptance criteria of ISO 10993. For chemical and structural composition, the "ground truth" was the known composition and structure of the predicate device. For performance characteristics, the "ground truth" was the expected performance and temperature/volume output of the predicate/reference device.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established
Not applicable.

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