(115 days)
Intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
The B& L-Bcta(Model: WL-B1) is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. This model has a temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate, Obtura Heated Gutta Percha System(K042828)
The B&L-Beta (Model: WL-B1) is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
Here's an analysis of the acceptance criteria and the study information provided:
1. Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance acceptance criteria in the traditional sense. The "acceptance criteria" here are implicitly that the new device is "as safe and effective as the predicate device," as stated in section 5 and 7.
The performance comparison is based on the characteristics of the device and its intended use, aligning them with the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K042828) | Reported Device Performance (B&L-Beta Model: WL-B1) | Met? |
|---|---|---|---|
| Intended Use | Heat gutta percha and place it into previously prepared root canals of human teeth for quick and complete obturation. | Heat gutta percha and place it into previously prepared root canals of human teeth for quick and complete obturation. | Yes |
| Power | 12V DC 1A | 3.7V Li-ion Battery (Difference noted, but deemed not to affect substantial equivalence) | N/A |
| Adapter | DC 12V 1A powered from the AC line | DC 12V 850mA for charging, powered from AC line (Difference noted, but deemed not to affect substantial equivalence) | N/A |
| Setting Temp. | 140, 150, 170, 180, 200°C | 100, 150, 180, 200, 230°C (Different range but within typical clinical needs; deemed not to affect substantial equivalence) | N/A |
| Needle Size | 21 G, 23 G, 25G | 21, 23, 25G | Yes |
| Material of Needle | Alloy of yellow copper, silver coated | Alloy of yellow copper, silver coated | Yes |
| Safety and Effectiveness | Demonstrated through bench and clinical testing to be safe and effective for its intended use. (Implicitly matches predicate's safety/effectiveness) | Bench and clinical testing indicates the new device is as safe and effective as the predicate device. | Yes |
Conclusion from the Submission: The company concluded that the B&L-Beta Model: WL-B is as safe and effective as the predicate device, and the technological differences are minor, thus rendering them substantially equivalent.
2. Sample Size and Data Provenance for Test Set
- The document states "bench and clinical testing data" but does not specify the sample size used for the test set in either the bench or clinical testing.
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: The document does not specify whether the clinical testing was retrospective or prospective. It generally refers to "bench and clinical testing data" without further detail.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test set. The evaluation focuses on comparison to a predicate device rather than an independent ground truth assessment by experts.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method as it does not detail a study involving expert readers or assessors forming a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not indicate that an MRMC comparative effectiveness study was done. The comparison is device-to-device based on technical characteristics and a general assertion of safety and effectiveness, not a study of human readers' performance with and without AI assistance.
6. Standalone Performance Study
- The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. This device is a physical instrument, not an AI algorithm.
7. Type of Ground Truth Used
- Given that this is a 510(k) for a physical dental instrument, the concept of "ground truth" in the context of diagnostic accuracy (like pathology or outcomes data) is not directly applicable.
- The "ground truth" for demonstrating substantial equivalence relies on:
- Technical specifications comparison to the predicate device.
- Performance (safety and effectiveness) demonstrated through bench and clinical testing, implicitly showing it performs its intended function adequately and without undue risk.
8. Sample Size for the Training Set
- The document does not mention a training set sample size. This device is a physical instrument and does not involve machine learning algorithms that require training data.
9. How Ground Truth for the Training Set was Established
- As there is no training set for this type of device, this question is not applicable.
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.