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The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.

PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva.

The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively.

The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.

The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.

Here's an analysis of the acceptance criteria and supporting study for the PerFect® Tissue Contouring System II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided documentation does not specify a discrete "test set" sample size for a clinical or in-vitro study involving patient data or images. The performance testing primarily focused on engineering and electrical safety standards compliance rather than a typical clinical evaluation with a test set of cases.

The provenance of data is therefore not applicable in the usual sense of clinical trial data. The compliance testing was performed by Underwriters Laboratories Inc. Melville Division in the USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study described is primarily an engineering and electrical safety compliance assessment, not a clinical study requiring expert labeling or adjudication of medical cases.

4. Adjudication Method

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with and without AI assistance. The device is an electrosurgical unit, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not conducted. The device is a physical electrosurgical unit, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily defined by:

• Recognized International and National Electrical Safety Standards: Such as IEC 60601-1, IEC 60601-2-2, EN55011, EN60601-1-2, CAN/CSA C22.2 series. Compliance with these standards served as the basis for safety and performance "truth."
• Predicate Device Performance: The functional capabilities and safety profile of the Strobex Ultron Electrosurge Unit (K850666) served as the benchmark for demonstrating "equally effective" performance.
• Functional Testing Results: The ability of electrodes to maintain function after repeated sterilization cycles.

8. The Sample Size for the Training Set

This information is not applicable. The PerFect® TCS II is an electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in this submission.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216°C (420° F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below.

1. Maximum recommended loads validated for the DDS 7000-115 sterilizer: -
   a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)-
   b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments, or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. - (OR)-
   c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) singlehandle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.

The DDS 7000, like the DDS 5000 is a convective dry heat batch sterilizer capable of sterilizing un-bagged dental instruments and cooling them for immediate use. It is designed for use with a dedicated rack system that provides for uniform loading to achieve optimum load distribution.
The DDS 7000 is equipped with a replaceable HEPA filter to comply with ANSI/AAMI ST50: 2004 cooling requirements. The HEPA filter has a filtration efficiency of 99.7% for 0.3-micron particles.
The DDS 7000 is a software-controlled device that allows for the user to preprogram options such as display units (Celsius or Fahrenheit), audible alarm enabled/disabled and safety interlock enabled/disabled The DDS 7000 monitors the entire cycle and will provide diagnostic error codes in the event of any failure or disruption to the sterilization cycle. A printable log is available for the most recently performed cycle that includes pass/fail notification and error codes if applicable

The Dentronix "DDS 7000" Rapid Dry Heat Sterilizer Sterilization System is designed for the dry heat sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216℃ (420° F).

Here's an analysis of its acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document mentions "Performance testing of the DDS 7000 was performed using Bacillus atrophaeus spore strips and inoculated tools." While the specific number of spore strips or inoculated tools used is not quantified, it implies a sufficient sample was used to demonstrate a 12-log reduction of spores. Full, partial, and empty chambers were also included in temperature studies.
• Data Provenance: The study was conducted by Coltene/Whaledent Incorporated for the purpose of a 510(k) premarket notification to the FDA. The data provenance is internal testing performed by the manufacturer in the USA (Cuyahoga Falls, Ohio). It is a prospective study as it involves specific performance testing of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This type of device (sterilizer) relies on established microbiological and engineering principles rather than clinical expert consensus for its "ground truth."

• Experts: Not applicable in the sense of medical image interpretation or diagnosis. The "ground truth" for sterilization efficacy is typically defined by microbiologists who assess the viability of biological indicators (spore strips) after exposure to the sterilization cycle.
• Qualifications: While not explicitly stated, it is assumed that personnel with expertise in microbiology, sterilization science, and engineering were involved in designing, executing, and analyzing the performance tests.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads where multiple experts evaluate cases and discrepancies are resolved). For sterilizer performance, the assessment is objective, based on laboratory results (e.g., no growth of Bacillus atrophaeus spores).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where the performance of human readers, with and without AI assistance, is compared. The DDS 7000 is a sterilization device, not a diagnostic imaging device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, a standalone performance study was done. The performance testing described (using Bacillus atrophaeus spore strips and inoculated tools) is a direct evaluation of the device's ability to sterilize, independent of human interaction during the sterilization cycle itself (though human operation is required to initiate the cycle). The study directly assesses the sterilizer's efficacy.

7. Type of Ground Truth Used:

The ground truth used is microbiological evidence. Specifically, the absence or reduction of viable microorganisms (spores of Bacillus atrophaeus) on biological indicators and inoculated tools after the sterilization cycle. This is an objective measure of sterilization efficacy.

8. Sample Size for the Training Set:

Not applicable. The DDS 7000 is a hardware device (dry heat sterilizer) with software controls, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software validation" mentioned refers to ensuring the software correctly controls the device and functions as intended, not to training a predictive model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for an AI or machine learning model in this context. The "software" validation principles refer to ensuring appropriate design, development, and testing of the control software to meet functional and safety requirements, as per FDA guidance documents.

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This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.

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The provided text is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent Incorporated for their Coltolux® LED Curing Light. It approves the device as substantially equivalent to legally marketed predicate devices.

*However, the provided text does not contain any information regarding specific acceptance criteria for device performance, the results of a study demonstrating such performance, or details about sample sizes, ground truth establishment, or expert involvement.

The letter focuses solely on the regulatory approval process and acknowledges the device's substantial equivalence for its stated indications for use, which is the polymerization of intraoral and extraoral restorations containing Camphorquinone.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone 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.

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One Coat SE Bond, a self etching dental adhesive, is indicated for the following:

• The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure.
• The bonding of direct fillings of composite or compomer. .
• The bonding of composite to amalgam. .
• The repairing of metal/ceramic, ceramic or composite restorations. .
• The sealing of sensitive teeth. .

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This document is a 510(k) clearance letter for a dental adhesive, not a study report or a document describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The document primarily focuses on regulatory approval rather than technical study details.

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Temporary fillings of Class I and II cavities.

Temporary sealing in endodontics.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

The document is a clearance letter from the FDA for a device called "Coltosol F." It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It also mentions the indications for use. However, it does not detail any performance metrics, studies, or acceptance criteria in the context of device performance.

Therefore, I cannot provide the requested information.

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Class II, IV fillings in anterior teeth; Small fillings in posterior teeth; Fillings of minimal cavities; Blocking out undercuts

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This document is a 510(k) clearance letter from the FDA for a dental device called "Synergy Flow." It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses.

Therefore, I cannot provide the requested information based on this document.

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Tenax White Posts are for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern.

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This is a 510(k) submission letter, not a study or device performance report. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics for a medical device is not available in the provided text.

The document states that the FDA has reviewed the Section 510(k) notification for the "Tenax White Post" and determined it to be substantially equivalent to devices marketed prior to May 28, 1976. This means the device is cleared for market based on its similarity to existing legal devices, rather than through a new clinical trial demonstrating performance against specific acceptance criteria.

The "Indications for Use" section (page 2) describes the intended purpose of the Tenax White Posts ("for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern"), but it does not provide any performance data or acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided document.

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ParaCem cement is for the discretionary use by dentists for the permanent cementation of endodontic posts into root canals after endodontic therapy has been completed.

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This document is a 510(k) clearance letter from the FDA for a dental cement product. It does not contain information about a device that uses artificial intelligence or machine learning, nor does it describe any acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot provide the requested information. The provided text is a regulatory approval document for a traditional medical device, not an AI/ML-driven one.

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