Search Results
Found 1 results
510(k) Data Aggregation
(141 days)
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
- The RomiApex™ A-15 is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.
- The RomiApex™ A-15 operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal.
- The measurements in RomiAPEX™ A-15 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated rather then mixed, as it is done in other apex locators, thus canceling the need for signal filtering and eliminating the noise caused by non-ideal filters.
- The device consists of a main body incorporating the LCD display, a lip Clip, a file clip a cable and a touch prob.
- The device is powered by one 1.5 AAA Alkaline battery.
The provided text is a 510(k) summary for the RomiApex™ A-15 Electronic Apex Locator. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and a specific study proving those criteria were met in the same way a de novo device would. Therefore, much of the requested information (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training ground truth was established) is not available in the provided text.
However, I can extract information related to the device's performance characteristics in comparison to its predicate.
1. Table of acceptance criteria and the reported device performance
The document presents a "Substantial Equivalence Comparison Table" (Table 5.6) which compares the RomiApex™ A-15 (Candidate Device) to the predicate device, BINGO-1020, focusing on characteristics rather than specific performance metrics and acceptance criteria in numerical terms. The acceptance criteria, in this context, appear to be that the candidate device's performance characteristics should be equivalent or better than the predicate's.
| Characteristic | Predicate Device (Bingo-1020) | Candidate Device (RomiApex™ A-15) | Equivalence Claim / Performance Relative to Predicate |
|---|---|---|---|
| Device definition | Electronic apex locator | Same as in Bingo-1020 | Equivalent |
| Intended Use | Precise apex localization during root canal treatment. | Same as in Bingo-1020 | Equivalent |
| Indications for use | Bingo-1020 is a modern device for precise apex localization during root channel treatment. Bingo-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed. | RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex. | Equivalent (description slightly different, but core indication is the same) |
| Where to be used (clinics, home etc.) | This product must only be used in hospital environments, clinics or dental offices by qualified dental personnel. | Same as in Bingo-1020 | Equivalent |
| Device category | Active, invasive | Same as in Bingo-1020 | Equivalent |
| Power Source | 2.4V NiMH rechargeable batteries | 1.5V alkaline primary battery | Different, but considered acceptable |
| External charger | Input: 230V/50-60Hz Output: 6Vdc @ 200mA | External charger is not required | Different, but considered acceptable |
| Current Consumption | Maximum - 30 mA DC. | Maximum – 13 mA DC. | Lower (better) |
| Method of calculating location of root canal apex | RMS functions of the measured signals at two frequencies are used to calculate the test scores which are compared to statistically predefined thresholds. | Same as in Bingo-1020 | Equivalent |
| Display | Custom monochrome LCD Display | Custom color LCD Display | Different, considered an improvement |
| Buttons | Three push buttons: 1. On / Off 2. Sound control 3. Demo MODE (training mode) | Two push buttons: 1. Same as in Bingo-1020 2. Same as in Bingo-1020 3. "Demo MODE" (for training) is not an offered feature in RomiApex™ A-15. | Slightly different feature set, considered acceptable |
| Sound indication | Piezo transducer with sound level control (high, medium, low, mute). | Same as in Bingo-1020 | Equivalent |
| Adjustment before measurement | Not required | Same as in Bingo-1020 | Equivalent |
| Calibration | Not required | Same as in Bingo-1020 | Equivalent |
| Measuring signal amplitude | Nominal - doesn't exceed 25 mV AC. The maximum voltage applied to the patient doesn't exceed 300 mV DC. | Same as in Bingo-1020 | Equivalent |
| Frequencies used for measurements | 500 Hz and 8 kHz | Same as in Bingo-1020 | Equivalent |
| Weight | 430 Gr | 100 Gr | Lighter (better) |
| Dimensions | W160 x H95 x T35 mm | W55 x H92 x T16mm | Smaller (better) |
| Files to be used with the device | Any kind of standard dental files may be used | Same as in Bingo-1020 | Equivalent |
| Safety features | The same connector on the device is used both for measuring cable connection and for battery charging. This safety feature prevents simultaneous connection of the device to the patient and to the mains via external charger. | No external charger should be connected to the device. And due that such safety feature is not needed in RomiApex™ A-15 at all. | |
| A new type of connector is used - Micro USB. This type of connector was specially designed to provide particularly high mechanical strength and is guaranteed by the manufacturer for 10,000 mating cycles. | Different (no external charger needed, improved connector strength) | ||
| Automatic on/off switch | Automatic turn-off after 5 min. of the idle state. | Same as in Bingo-1020 | Equivalent |
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 separate "test set" or provide details on sample size, data provenance, or whether it was retrospective or prospective. The submission is for substantial equivalence, which primarily relies on comparing device specifications and intended use to a legally marketed predicate device.
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 available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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 available in the provided text. Electronic Apex Locators are not AI systems in the context of "human readers" interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The RomiApex™ A-15 is a device for measuring the distance to the root apex during root canal procedures, it's not an "algorithm only" device. Its performance is measured directly by its ability to accurately determine the apex, which is inherent in its design and comparison to the predicate. No specific "standalone" performance study in the context of an AI algorithm is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For apex locators, "ground truth" for accuracy would typically be established by direct measurement with radiography or physical measurement after tooth extraction, compared to the device's reading. However, this level of detail for a performance study is not included in the 510(k) summary provided. The comparison relies on the predicate's established performance and the candidate device's similar scientific technology.
8. The sample size for the training set
This information is not available in the provided text, as this type of device does not have a "training set" in the context of machine learning. Its operation is based on established electrical impedance principles.
9. How the ground truth for the training set was established
This information is not available in the provided text, for same reasons as point 8.
Ask a specific question about this device
Page 1 of 1