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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.

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.

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The Obtura is intended for used by professionally qualified dentists, endodontists and dental 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 device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and 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 Heated Gutta Percha System, #K832654.

This document is a 510(k) summary for the Obtura Heated Gutta Percha System and its FDA clearance letter. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.

The 510(k) process is primarily a premarket notification mechanism to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not require clinical trials or studies proving specific performance metrics against pre-defined acceptance criteria, especially for Class I or II devices like this one.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that the device is "an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide" and that it "has the same technological characteristics" as the predicate device, with electronics updated "to comply with current standards and regulations," and materials/design selected for "better aesthetics and asepsis." This indicates a focus on equivalence and regulatory compliance rather than novel performance claims requiring new clinical evidence.

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The Elements Obturation Unit is intended to be used in Dentistry to:

1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus,
2. For tissue cauterization and coagulation, and
3. To backfill and downpack gutta percha during Endodontic root canal treatment.
4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.

The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may select the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.

The provided text is a 510(k) Summary for the "Elements Obturation Unit," a dental device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory submission for premarket notification, focusing on demonstrating that the device is "substantially equivalent" to already legally marketed devices. This regulatory pathway typically relies on comparing the new device's technological characteristics and intended use to a predicate device, rather than requiring formal clinical trials or new performance studies to demonstrate safety and effectiveness from scratch.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text does not contain this information.

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