(24 days)
Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.
The Osstell® ISQ Implant Stability Meter is an updated version of the Osstell Mentor (K033689). The system is designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K033689, the Osstell ISQ is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a SmartPeg (aluminum rod) attached to the dental implant by means of a screw. The SmartPeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the SmartPeg.
The provided text unfortunately does not contain detailed information about acceptance criteria or a specific study proving the device meets these criteria in the way typically expected for a detailed scientific or regulatory report.
The document is a 510(k) Premarket Application for the Osstell® ISQ Implant Stability Meter, indicating it's an updated version of a previously cleared device (Osstell Mentor). The primary focus of this document is to demonstrate "Substantial Equivalence" to the predicate device, not to present a comprehensive de novo study validating new performance criteria or clinical efficacy.
However, I can extract the available information and structure it as requested, acknowledging the limitations of the provided text.
Here's an analysis based on the given text:
Description of the Device and its Purpose:
The Osstell® ISQ Implant Stability Meter is a portable, handheld instrument designed to measure dental implant stability using Resonance Frequency Analysis (RFA). It uses a SmartPeg attached to the dental implant which is excited by a magnetic pulse. The resonance frequency, an indicator of implant stability, is calculated and displayed as an Implant Stability Quotient (ISQ). The device is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region, adding information to implant stability evaluation.
Reason for 510(k) Application:
The modifications from the predicate device (Osstell Mentor) include changes to circuit boards, integration of a docking station, and software. The application states these do "not affect the safety or performance of the device and do not change the intended use."
Acceptance Criteria and Study Details (Based on available information):
Due to the nature of a 510(k) for a modified device seeking substantial equivalence, specific "acceptance criteria" and detailed "device performance" in terms of clinical outcomes or comparative efficacy found in a de novo study are not explicitly stated in the provided text. Instead, the focus is on demonstrating that the modifications do not negatively impact safety or performance compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Stated Goal) | Reported Device Performance (as stated in the document) |
|---|---|
| Maintain the safety and performance of the predicate device (Osstell Mentor K033689). | "The modifications... do not affect the safety or performance of the device and do not change the intended use of the Osstell ISQ." |
| "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." | |
| "The Osstell ISQ was subject to the same preclinical requirements as the predicate device." | |
| Compliance with design specifications of the modified components (circuit boards, software). | "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." |
| (No specific numerical performance metrics are provided in this summary.) | |
| Continued equivalence to the predicate device. | "The change to the circuit boards, integration of the docking station, and the software of the Osstell ISQ do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell Mentor previously cleared in K033689." |
| "The modified Osstell ISQ has the following similarities to the Osstell Mentor previously cleared in K033689: same indicated use, same operating principle, same basic device design and physical properties, same materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "verification and validation tests" and "Performance testing" but does not provide numbers for test sets used.
- Data Provenance: Not explicitly stated. Given that this is a 510(k) for a device from a Swedish company (Osstell AB, Goteborg, Sweden) and the "Summary of Nonclinical Testing" mentions testing for compliance to design specifications, it's highly likely that this testing was internal, conducted by the manufacturer, and likely occurred at their facilities or approved contract labs. The document does not indicate prospective clinical trials or retrospective studies from specific countries for this specific submission's performance validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the text. Since this is a submission focused on technical modifications and substantial equivalence validation (primarily non-clinical performance testing), there is no mention of expert-established ground truth for a clinical test set in the provided summary.
4. Adjudication Method for the Test Set
- This information is not provided in the text. Adjudication methods are typically relevant for clinical studies involving multiple reviewers, which is not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on the device itself and its technical modifications, not on comparing human reader performance with and without AI assistance (as the device is a measurement tool, not an AI diagnostic aid).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself, the Osstell ISQ, is a standalone measurement instrument. Its "performance testing" described in the summary would be standalone, verifying its ability to accurately measure resonance frequency and calculate ISQ values as designed. However, the text does not detail the methodology or specific results of such standalone testing beyond stating that "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed."
7. The type of Ground Truth Used
- For the non-clinical performance testing mentioned, the "ground truth" would generally be the engineering specifications and expected outputs of the device's components and software. This would involve calibrated test equipment and established reference standards to verify that the device accurately measures resonance frequency and computes the ISQ within acceptable tolerances.
- For the broader claim of "safety and effectiveness" remaining equivalent to the predicate, the "ground truth" is established by the prior clearance of the Osstell Mentor (K033689), implying its established clinical utility and safety for measuring implant stability. This submission leverages that established utility rather than generating new clinical ground truth.
8. The Sample Size for the Training Set
- This information is not provided. As the device is a measurement instrument based on physical principles (Resonance Frequency Analysis) and signal processing, it is not described as utilizing a "training set" in the context of machine learning algorithms. The software changes are mentioned, but not in a way that suggests a trainable algorithm requiring a data-based training set.
9. How the Ground Truth for the Training Set was Established
- As a "training set" is not indicated to be part of the device's development or validation, this question is not applicable based on the provided text.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.