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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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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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