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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

• Fit of the barrier sleeve onto the EI DownPak Endodontic Obturator Handpiece
• Ease of use (application and removal)
• Readability of the DownPak display through the barrier sleeve
• Activation of controls (on/off and vibration button) through the barrier sleeve
• Ease of disposal of the barrier sleeve
• Resistance to tearing of the barrier sleeve
• Tactile sensitivity through the barrier sleeve | - Evaluated in field validation study #604 by clinicians. The study successfully completed, indicating satisfactory performance across these aspects. Specific quantitative metrics or pass/fail thresholds for these criteria are not provided in the summary. |
  | Material Compliance:
• Material construction meets requirements for poly products (referenced in 21 CFR 177.1340 and 177.1520) | - The material construction meets the requirements for poly products, referenced in Part 177 21 CFR (specifically 177.1340 and 177.1520). |
  | Biocompatibility:
• Sensitization
• Cytotoxicity
• Irritation | - Tested and certified to be in compliance for sensitization, cytotoxicity, and irritation as specified in ISO 10993. |
  | Infection Control Barrier Efficacy:
• Viral penetration resistance | - Tested and certified to be in compliance for viral penetration in accordance with ASTM F1671. |
  | Compliance to Standards:
• Manufactured to ASTM E1104-98 | - All of TIDI Products probe cover products (i.e. thermometer sheath, instrument sheaths, and dental camera covers) are manufactured to ASTM E1104-98. (This is a statement about the predicate device, but since the new device is identical, it implies this applies to the new device as well). |

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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