(42 days)
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.
| Performance Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| General Performance | (Implied: Meets recommended specifications) | "Results of in-house testing with Hu-Friedy ultrasonic inserts (ref. K953919 and K912473) in the Swerv Scaler demonstrated that they performed within recommended specifications." |
| Frequency and Stroke Data | (Implied: Equivalency to predicate devices; meets ISO 22374) | "Moreover, analysis of frequency and stroke data demonstrated equivalency to predicated devices in the market and that the Swerv scaling system meets ISO 22374 requirements." |
| Electromagnetic Compatibility (EMC) | (Implied: Compliance with international requirements) | "EMC and Safety testing conducted by Underwriters Laboratories on the Swerv System have demonstrated compliance with the international requirements for this device." |
| Safety and Efficacy | (Implied: Safe and efficacious for intended use) | "The performance testing performed on the Swerv Magnetostrictive Ultrasonic Scaler demonstrates the safety and efficacy for its intended use." Additionally, "All the materials used in the device have been used in legally marketed Hu-Friedy devices or found to be safe for dental use." |
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.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.