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This product is intended for use by dental professionals only. This device is an accessory to the EI DownPak Endodontic Obturator Handpiece which is used in the oral cavity for root canal therapy. The barrier sleeve will be used to cover the hand piece thereby reducing the risk of cross infection while in use.

The EI® brand DownPak Barrier Sleeves are similar to the TIDI Product (SaniTherm) Disposable Thermometer Sheaths listed above. The El DownPak Barrier sleeve and the predicate TIDI Products Disposable Thermometer Sheaths are intended for use by medical professionals in the oral cavity as infection control devices. The EI DownPak Barrier Sleeve will be use to cover the El DownPak Endodontive Obturator Handpiece which is used for root canal therapy. The CDC Guidelines for Infection Control in Dental Healt Care Settings (Vol. 52, No. RR-17, ng 20, December 19, 2003) references the use of disposable barrier protection. The El DownPak Barrier sleeves will be used in combination with the cleaning instructions for the EI DownPak Obturator handpiece which recommends wiping the surface of the handpiece with a soft cloth dampened with pH neutral surface disinfection solution or mild detergent (not containing phenols). Hu-Friedy will purchase the barrier sleeves from TIDI Products, formerly Banta Healthcare Products, as an own brand private label device. The EI DownPak Barrier Sleeves are identical to the TIDI Products Disposable Sheaths in shape, material, and design. All of the technical specifications are identical to the marketed TIDI Products device. EI has 510k (K070246) approval to market the marketed device in the US. The EI DownPak barrier sleeves are compatible with the EI DownPak handpiece. The El DownPak barrier sleeves are identical to the TIDI Products Disposable Thermometer Sheaths. All of TIDI Products probe cover products (i.e. thermometer sheath, instrument sheaths, and dental camera covers) arc manufactured to ASTM E1104-98. The material construction meets the requirements for poly products, referenced in Part 177 21 CFR (specifically 177.1340 and 177.1520). These sheaths have been tested and certified to be in compliance for sensitization, cytoxicity, and irritation as specified in ISO 10993 eomphally, these sheaths have been tested and certified to be in compliance for viral penetration in accordance with ASTM F1671.

The information provided indicates that the EI DownPak Barrier Sleeves are similar to the TIDI Products (SaniTherm) Disposable Thermometer Sheaths. The manufacturer, Hu-Friedy, intends to private label the barrier sleeves from TIDI Products. The 510(k) submission for the EI DownPak Barrier Sleeves leverages the substantial equivalence to the predicate device, emphasizing identical design, materials, and technical specifications.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The primary study mentioned is field validation study #604.

• Sample size used for the test set: Not explicitly stated as a numerical value for patients or devices. The study involved "clinicians" evaluating the device, implying a qualitative assessment by multiple users rather than a statistically defined test set size typical for quantitative performance metrics.
• Data provenance: Prospective, as it was a field validation study where clinicians evaluated the device. The country of origin for the data is not explicitly stated, but given the submission is to the FDA for a US market device by a US-based company, it can be inferred to be from the US or a region adhering to similar clinical practices.

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

• Number of experts: Not explicitly stated as a specific number. The summary mentions "clinicians" without specifying how many.
• Qualifications of those experts: "Clinicians" are mentioned, which would typically imply dental professionals or those involved in patient care. No specific qualifications (e.g., years of experience, specialty) are provided.

4. Adjudication Method for the Test Set

The field validation study #604 appears to be a qualitative assessment by clinicians. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) for the results of this study. The wording "successfully completing a field validation study #604 where clinicians evaluate..." suggests a collective positive outcome rather than a formal, adjudicated reading of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The primary focus of this submission is demonstrating substantial equivalence to a predicate device and validating basic functional performance through a field study. There is no mention of comparing human readers' performance with and without AI assistance, as AI is not a component of this barrier sleeve device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone (algorithm only) performance study was not done. This device is a passive barrier sleeve, not an algorithm or an AI-powered system, so such a study would not be applicable.

7. The Type of Ground Truth Used

For the field validation study #604, the ground truth was expert assessment/consensus (from the clinicians). The criteria evaluated (fit, ease of use, readability, control activation, disposal, tearing resistance, tactile sensitivity) are subjective and based on the practical experience and judgment of the clinicians using the device.

For the material, biocompatibility, and viral penetration testing, the ground truth was established by standardized testing protocols (e.g., ASTM E1104-98, ISO 10993, ASTM F1671) and their associated pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "EI DownPak Barrier Sleeves" are physical accessories.

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

Not applicable. As stated above, this device does not involve a training set.

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The intended use of the dental instrument heater - The Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percha (softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment. The device may only be operated by dentists and endodontists.

The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.

The provided text describes a 510(k) summary for the "Down Pak" dental instrument, which is a battery-operated heater designed to provide continuous heat and/or vibration to the tip of a dental instrument for endodontic procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device ("EndoTwinn") and compliance with recognized consensus standards.

Based on the provided text, the following information can be extracted regarding acceptance criteria and device performance:

1. A table of acceptance criteria and the reported device performance:

The document states compliance with several international standards but does not provide specific quantitative acceptance criteria or detailed device performance metrics within the context of these standards. It generally asserts that the device "complies with the requirements of recognized consensus standards."

It's important to note: The document does not provide specific numerical or qualitative performance results (e.g., "device maintained temperature within X range for Y duration") for any of these standards. It only states general compliance.

2. Sample size used for the test set and the data provenance:

The document does not specify a sample size for a test set that would typically be associated with clinical performance or direct device efficacy studies. The "Device Testing Results" section refers to compliance with consensus standards, which are often tested on individual units or small batches of devices for design verification rather than a large clinical test set.

Data provenance (country of origin, retrospective/prospective) is not mentioned in relation to any specific testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since a clinical test set with human subject outcomes or expert-adjudicated results is not described in this 510(k) summary, information regarding the number and qualifications of experts for ground truth establishment is not available.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

As no clinical test set requiring expert adjudication is described, the adjudication method is not applicable and therefore not mentioned.

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 document describes a dental instrument heater, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This device is a hardware instrument, not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the standards compliance mentioned (IEC, ISO), the "ground truth" would be the successful demonstration that the device design and manufacturing meet the technical specifications and safety requirements outlined in those standards (e.g., electrical parameters, biocompatibility test results). This is not typically "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather engineering and laboratory test results against established performance criteria within the standards.

8. The sample size for the training set:

The concept of a "training set" is relevant for machine learning or AI models. This document describes a physical medical device, not a software algorithm. Therefore, information regarding a training set sample size is not applicable and not provided.

9. How the ground truth for the training set was established:

As there is no training set mentioned (given the nature of the device), this information is not applicable and not provided.

In summary:

The provided 510(k) summary for the "Down Pak" dental instrument focuses on demonstrating substantial equivalence to a predicate device and compliance with established international consensus standards for medical devices (electrical safety, EMC, risk management, biocompatibility). It does not include details of clinical studies, expert-adjudicated test sets, or AI/algorithm performance metrics, as these are not relevant to the type of device being described. The "Device Testing Results" section refers to general compliance with these standards rather than specific quantitative performance criteria.

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Gutta percha is inserted into rout canal following root canal preparation.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device named "TGP" (Gutta Percha). It confirms the device's substantial equivalence to legally marketed predicate devices.

This document does not contain any information about:

• Acceptance criteria for a device's performance.
• Any study that proves the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about a study, as this information is not present in the provided text.

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The intended use of the dental instrument heater – The EndoTwinn - is to provide continuous heat and/or vibration at the tip of a dental instrument. The EndoTwinn is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment The device may only be operated by dentists and endodontists.

The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.

This document is a 510(k) summary for the EndoTwinn dental instrument heater. It describes the device, its intended use, and states that it has been tested and complies with relevant standards, thereby establishing substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or the study that proves the device meets those criteria.

Here’s a breakdown of the information requested, based on the provided text, and explicit statements about what is NOT present in the document:

1. A table of acceptance criteria and the reported device performance

• Not provided. The document states, "The devise is tested thoroughly and it complies to the standards for this class II a medical device." However, it does not specify what those standards are, what the acceptance criteria defined by those standards were, or what the specific performance results were against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. There is no mention of a specific test set, sample size, or data provenance.

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)

• Not applicable / Not provided. The device is a "dental instrument heater," which is a physical tool, not a diagnostic or AI-driven device that would require ground truth established by experts for performance evaluation in the typical sense (e.g., for image interpretation). The "testing" mentioned is likely related to electrical safety, temperature accuracy, and mechanical function, not clinical diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. Similar to point 3, this is not relevant for the type of device described.

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

• No. This is not an AI-based device, nor is it a diagnostic device that would involve human readers or comparative effectiveness studies of this nature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical dental instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. The concept of "ground truth" as it applies to diagnostic or AI performance is not relevant here. The testing would involve objective measurements against engineering specifications and safety standards for the device's physical functions (heating, vibration, safety).

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable / Not provided. This is not an AI/machine learning device.

In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence for a physical dental instrument. It confirms the device was tested and complies with standards but does not detail the specific acceptance criteria or the specific results of those tests as would be expected for a diagnostic or AI-powered device.

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Fiberfill SGP is a root canal filling thermal plastic composite material used for endodontic therapy to fill the root canal of a tooth in replacing conventional Gutta Percha material.

Fiberfill SGP is a root canal filling thermal plastic composite material.

This document is an FDA letter regarding the clearance of a medical device, Fiberfill™ SGP, as substantially equivalent to a predicate device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document and not a scientific study report.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
6. Results of a standalone algorithm study.
7. Type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.

Antibacterial Gutta Percha

This document is an FDA 510(k) clearance letter for an "Antibacterial Gutta Percha" device, K971641. The letter indicates that the device has been found substantially equivalent to predicate devices, thus allowing it to be marketed.

However, the provided text does not contain any information regarding:

• Acceptance criteria or reported device performance.
• Study details (e.g., sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details).

The letter solely focuses on the regulatory aspects of the device's clearance based on its substantial equivalence to previously marketed devices, rather than data from a clinical or performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about a study, as this information is not present in the provided document.

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The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.

The THERMAPREP® PLUS OVEN is a heating unit for obturators. The system allows for individual heating of ThermaFil® gutta percha obturators. Microwave technology is used to produce uniform predictable heating results.

This document is a 510(k) summary for a medical device called the "THERMAPREP® PLUS OVEN," which is a heating unit for endodontic obturators. It's a pre-market notification that demonstrates the device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Various sizes of ThermaFil® endodontic obturators" were tested. No specific number is provided.
• Data Provenance: The data appears to be prospective, as it describes experiments conducted with the new device and a predicate device. The country of origin is not specified, but the applicant (Tulsa Dental Products) is based in Tulsa, OK, USA, suggesting the study was likely conducted in the US.

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

• This information is not provided in the document. The testing appears to be performance-based (heating times, uniformity) rather than dependent on expert interpretation of results.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The evaluation seems to be based on objective performance metrics (heating times, uniformity) rather than subjective expert adjudication. As such, there is no mention of 2+1, 3+1, or other adjudication methods.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not conducted. This device is a heating oven, not an imaging or diagnostic AI tool that would typically involve human readers. The comparison was between the new device and a predicate device's performance characteristics.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, in a sense, a "standalone" study of the device's performance was done. The document describes testing the THERMAPREP® PLUS OVEN independently and in comparison to the predicate device to evaluate its heating capabilities and efficiency. "Algorithm only" is not relevant here as it's a physical device, not a software algorithm.

7. The Type of Ground Truth Used

• The ground truth appears to be based on objective performance measurements related to heating – specifically, heating times and the ability to achieve uniform and predictable heating of obturators. There's no mention of expert consensus, pathology, or outcomes data as "ground truth" in the traditional sense for diagnostic tools.

8. The Sample Size for the Training Set

• This information is not provided and is not applicable. This device is a physical heating appliance, not a machine learning model that requires a "training set."

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

• This information is not provided and is not applicable. As mentioned above, there is no training set for this type of device.

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