(185 days)
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."
| Acceptance Criteria Category | Specific Test / Requirement | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Cytotoxicity (ISO 10993-5) | Successfully met test criteria |
| Sensitization (ISO 10993-10) | Successfully met test criteria | |
| Irritation (ISO 10993-23) | Successfully met test criteria | |
| Acute Systemic Toxicity (ISO 10993-11) | Successfully met test criteria | |
| Material Mediated Pyrogenicity (USP-NF ) | Successfully met test criteria | |
| Flammability (CFR Part 16 §1500.45) | Non-flammable characteristics validated | |
| Functionality | Needle Clearance Testing | Verified non-contact of spray on user-provided dental needle |
| Fit and Form Testing (Dental Syringe Compatibility) | Ensured adequate compatibility with user-provided dental syringes (60-80mm length, 11-13mm diameter) | |
| Positive Shutoff Release | Mechanism has positive shutoff release (compared to predicate) | |
| Performance | Temperature Profile on Oral Mucosa | Provided similar thermal profile characteristics on oral mucosa as reference device (Vapocoolshot Mist /CoolJect) provides on skin |
| Usability | End-User Validation Testing | Conducted across multiple intended user groups and under simulated use conditions |
| Shelf Life | Initial Shelf Life | 24 months, with testing ongoing for 3-year shelf life |
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.
N/A