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This device generates ultrasonic vibrations intended for ultrasonic procedures: 1.) General Supra and Subgingival scaling applications; 2.) Periodontal debridement for non-surgical treatment of Periodontal diseases.

The Swerv Magnetostrictive Ultrasonic Scaler is a portable stand alone scaler, handpiece and foot control. The Swerv Magnetostrictive Ultrasonic Scaler operates at 25 kHz and accepts voltage inputs between 100-240V. The available power output is segmented into two over zones to assist the user in selecting the recommended power setting for a selected ultrasonic insert. The power and water controls of the Swerv' Scaler are located in the control unit. The Swerv2 Magnetostrictive Ultrasonic Scaler plugs into an ordinary electrical outlet and converts the AC current into high frequency electro-mechanical vibrations. The Swerv3 Scaler features a patented switching mechanism to support the use of either 25 kHz or 30 kHz inserts. Therefore, the scaling system accepts both Hu-Friedy 25 kHz and 30 kHz Ultrasonic Inserts.

The provided text describes a 510(k) summary for the Hu-Friedy Swerv Magnetostrictive Ultrasonic Scaler System. It details the device, its intended use, and technological characteristics, along with evidence of its performance and substantial equivalence to predicate devices. However, the document does not contain the level of detail typically found in a clinical study report or a comprehensive validation study that would outline acceptance criteria and specific study results in the structured format requested.

Therefore, it is not possible to fully answer all aspects of your request based on the provided text. I will extract the information that is present and indicate where information is missing.

Acceptance Criteria and Device Performance for Swerv Magnetostrictive Ultrasonic Scaler System

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria are not explicitly stated. The performance is described in qualitative and comparative terms.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "in-house testing" and "analysis of frequency and stroke data" but does not give specific numbers of tests or samples.
• Data Provenance: The testing was "in-house testing" conducted by Hu-Friedy and "EMC and Safety testing conducted by Underwriters Laboratories." The data appears to be retrospective as it was collected as part of the device development and submission process. The country of origin of the data is implicitly USA, as Hu-Friedy MFG. CO. INC. is located in Chicago, IL, USA.

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

• This information is not provided in the document. The document describes engineering and performance testing, not a study involving experts establishing ground truth for a test set in a clinical context.

4. Adjudication Method for the Test Set

• This information is not provided. The type of testing described (engineering performance, EMC, safety) typically does not involve adjudication in the clinical sense.

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

• No, an MRMC comparative effectiveness study is not mentioned in the document. The study described focuses on the device's technical specifications and safety/efficacy relative to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• This is not applicable as the device described is a physical medical device (ultrasonic scaler), not a software algorithm with standalone performance.

7. Type of Ground Truth Used

• The ground truth for the performance claims appears to be based on engineering specifications and established regulatory standards. For "frequency and stroke data," it was compared to "predicated devices in the market" and compliance with "ISO 22374 requirements." For "EMC and Safety testing," it demonstrated "compliance with the international requirements."

8. Sample Size for the Training Set

• This is not applicable as the device is hardware, not an AI algorithm requiring a training set in the conventional sense. The "in-house testing" mentioned would be more akin to validation/verification testing.

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

• This point is not applicable as there is no mention of a training set for an AI algorithm.

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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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This product is intended for use by dental professionals only. This device generates ultrasonic vibrations intended for use in dental applications such as scaling, periodontal therapy, root canal treatment and cavity preparation.

The Hu-Friedy® brand Symmetry IQ Ultrasonic Scalers are similar to the Ultrasonic Scalers of the predicate device listed above. These devices are intended for use by dental professionals only. These devices generate ultrasonic vibrations intended for use in dental applications such as scaling, periodontal therapy, root canal treatment and cavity preparation. Hu-Friedy will purchase the generators from NSK, Inc. (Nakanishi) and own brand private label the device. The modifications to the Hu-Friedy product are cosmetic in nature and consist mainly of new shape and design to the housing of the control unit. All of the internal electrical and technical specifications are identical to the marketed NSK units. Hu-Friedy currently has a 510k (K053178) approval for the Symmetry line of piezoelectric tips that are compatible with Satelec and NSK piezoelectric ultrasonic scalers. The addition of the Symmetry IQ generators and handpiece will complete our ultrasonic piezo scaling product line. The Symmetry IQ Ultrasonic Scalers have essentially the same design as the predicate device's ultrasonic generators. The Symmetry IQ 2000 series is equivalent to the Varios 150 Lux (Optic), which is an integrated version of the Varios 350 Lux (Optic) to be used in the delivery tray table as a built in system. The Symmetry IO 3000 series is equivalent to the combination of the Varios 550 control unit with the handpiece used in the Varios 350 Lux (Optic). The Symmetry IQ 3000 unit is based on the NSK Varios 560 which is currently pending FDA 510k approval. The addition of a silicone grip to the ultrasonic generator handpiece used in both models is the only significant change and the reason for the new 510k application.

This submission describes the Symmetry IQ Dental Ultrasonic Scaler, a dental device used for various dental applications. The basis of the 510(k) clearance is substantial equivalence to a predicate device, as opposed to a new algorithm-based device requiring extensive performance testing against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth for an AI/algorithm-based device is not applicable to this 510(k) submission.

The document states that:

• "The modifications to the Hu-Friedy product are cosmetic in nature and consist mainly of new shape and design to the housing of the control unit. All of the internal electrical and technical specifications are identical to the marketed NSK units."
• "The Symmetry IQ Ultrasonic Scalers have essentially the same design as the predicate device's ultrasonic generators."
• The "addition of a silicone grip to the ultrasonic generator handpiece used in both models is the only significant change and the reason for the new 510k application."

The studies mentioned (sterilization study, biocompatibility testing, ISO 22374 life testing) are safety and performance verification tests for the modified components and overall device, rather than comparative effectiveness studies for an AI-driven diagnostic or therapeutic tool.

As such, I cannot populate the table and answer the specific detailed questions as they are designed for performance evaluation of AI/ML software or algorithms, which is not the nature of this device's submission.

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To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.

The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification, (27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator.

The provided 510(k) summary focuses on the substantial equivalence of the Symmetry S-Series Piezo Scaling Tips to predicate devices. The "study" mentioned is a field evaluation rather than a rigorous clinical trial with quantified acceptance criteria in the typical sense for a medical device with objective performance metrics.

Here's an attempt to extract and format the information based on the provided text, while acknowledging its limitations for certain categories:

Acceptance Criteria and Device Performance Study

The primary study mentioned is a field evaluation comparing the Symmetry S-Series Piezo Scaling Tips to a predicate device's competitive tip.

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: Not explicitly stated. The text only mentions "clinicians were asked to evaluate."
• Data Provenance: Not explicitly stated. Likely refers to a prospective evaluation conducted by dental professionals. Country of origin not specified.

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

• Number of Experts: Not explicitly stated. The text refers to "clinicians" in the plural, but
  the exact number is not provided.
• Qualifications of Experts: The experts are described as "clinicians," implying dental professionals (e.g., dentists, dental hygienists). No specific years of experience or board certifications are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The evaluation seems to be based on individual clinician perceptions, summarized as an "overall conclusion." There is no indication of a formal adjudication process (e.g., 2+1 or 3+1 consensus).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was a field study assessing subjective perceptions from clinicians, not a formal MRMC study evaluating diagnostic or therapeutic accuracy with quantifiable endpoints.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this device is a physical dental scaling tip and not an AI-assisted diagnostic or therapeutic tool.

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

• Standalone Performance: Not applicable, as this device is a physical dental scaling tip and not an algorithm. The "mechanical compatibility" tests (resonant frequency, tip displacement) can be considered standalone performance for the physical device characteristics, confirming it operates within specified parameters before human use.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical aspects, the ground truth was engineering specifications and measurements (e.g., resonant frequency range, consistent linear tip displacement). For the clinical performance, the "ground truth" was essentially expert subjective opinion/perception (clinician evaluations of scaling efficiency, adaptability, water delivery, patient comfort, and overall preference) in comparison to a predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI. The design and validation of the device were based on engineering principles and compatibility with existing equipment.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device. The design was established based on existing knowledge of piezoelectric ultrasonic technology and the characteristics of predicate devices, with lab tests verifying mechanical characteristics.

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To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.

The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.

The provided 510(k) summary for the Hu-Friedy® brand Satin Swivel™ ultrasonic insert describes its equivalence to a predicate device and includes information about performance evaluation. However, it does not contain detailed statistical acceptance criteria or a comprehensive study report in the format typically required for medical device AI/ML performance evaluation. This document is for a mechanical device, not an AI/ML device, so many of the requested categories (like number of experts, adjudication, MRMC, training sets) are not applicable.

Based on the provided text, here's a summary of the acceptance criteria and study as described, with an acknowledgment of the limitations due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. For the "field study," it mentions "clinicians were asked to evaluate the inserts." The number of clinicians or the number of cases/patients observed is not provided.
• Data Provenance: The study was a "field evaluation," implying prospective data collection during actual clinical use by dental professionals. The country of origin is not specified, but the applicant is based in Chicago, IL, USA.

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

• Number of Experts: Not explicitly stated. The study involved "clinicians" evaluating the device. It implies multiple clinicians, but the exact number is not given.
• Qualifications of Experts: They are referred to as "dental professionals" and "clinicians," indicating they are qualified to use and evaluate dental instruments. No specific years of experience or board certifications are mentioned.

4. Adjudication method for the test set

• Adjudication Method: Not described. The text states that "clinicians were asked to evaluate the inserts." It appears to be a direct assessment by the clinicians without a formal adjudication process described for conflicting opinions. The "overall conclusion of this evaluation" suggests a consensus or summary of their findings, but no specific method like 2+1 or 3+1 is 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

• MRMC Study: No, an MRMC study was not conducted. This is not an AI/ML device, but a mechanical dental instrument. The comparison was between the new mechanical device and a predicate mechanical device, evaluated by clinicians.
• Effect Size of AI: This is not applicable as the device does not involve AI assistance.

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

• Standalone Performance: Not applicable. This is a mechanical device, not an algorithm. The "laboratory tests" can be considered a form of standalone testing for the mechanical properties of the device itself (cleaning, sterilization, mechanical life).

7. The type of ground truth used

• Ground Truth Type: For the field evaluation, the "ground truth" was established through expert opinion/assessment by dental professionals on the device's performance in real-world clinical use. For the laboratory tests, the ground truth would be based on established engineering and regulatory testing standards for cleaning, sterilization, and mechanical durability.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. As a mechanical device, it does not use machine learning, and therefore does not have a "training set" in the context of an AI/ML device.

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

• Training Set Ground Truth: Not applicable. No training set as it's not an AI/ML device.

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