(85 days)
The SURGmatic S15 L Pro handpiece is intended for:
- Oral, jaw and facial surgery
- Tooth extraction procedures
- Root resection
- Osteotomy
- Removal of carious material
- Tooth, cavity and crown preparations
- Processing of fillings
The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.
The electrical-driven SURGmatic S15 L Pro handpieces in accordance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. The device is an electrically driven handpiece that is reusable and provided with a fiber optic light system. The electrical motor includes the light source and the SURGmatic S15 L Pro handbiece is provided with a fiber optic light transmitter to transport the light to the bur side. DIN EN ISO 14457 requlates the minimum illuminance. The dental handpieces can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces equipped with a handpiece connector in accordance with ISO 3964 are connected to a treatment unit by means of a hose and the electrical motor and receive the energy for the gear, cooling water and air for conservative dental treatment as well as the light for illumination of the operation area through corresponding output openings. Burs in accordance with ISO 1797-1 must be used with the SURGmatic handpieces. Based on the INTRAmatic connection that meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The SURGmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.
The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71).
The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.
The provided document is a 510(k) premarket notification for a dental handpiece (SURGmatic S15 L Pro). Unlike submissions for AI/ML-driven medical devices that involve complex algorithms and require extensive performance studies, this document focuses on demonstrating substantial equivalence to existing predicate devices based on common technological characteristics, intended use, and adherence to established international standards.
Therefore, many of the questions regarding acceptance criteria and performance studies in the context of AI/ML or diagnostic devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of device submission.
The document primarily relies on non-clinical bench testing against recognized industry standards to demonstrate that the new device performs comparably to its predicates and meets safety and performance requirements.
Here's an attempt to answer the questions based on the information available in the document, highlighting where the requested details are not relevant to this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not present specific "acceptance criteria" in the format of quantitative thresholds for device performance against a particular medical outcome, as might be seen for an AI diagnostic tool. Instead, acceptance is demonstrated by adherence to established international standards for dental handpieces and by demonstrating substantial equivalence to predicate devices in typical performance characteristics.
The "reported device performance" is implicitly demonstrated through the device complying with the standards listed. The acceptance criteria are the criteria outlined in these standards.
| Acceptance Criteria (Demonstrated by Compliance with Standards) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Biocompatibility: Meets ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405 | The device materials are biocompatible and do not pose a biological risk to patients. |
| Mechanical Performance: Meets ISO 14457 (Dentistry - Handpieces and motors) | The handpiece meets mechanical performance specifications, including bur retention, torque, speed, and durability. |
| Sterilization: Sterilizable according to ISO 17665-1 (Moist heat sterilization), AAMI / ANSI ST79 | The device can be safely and effectively sterilized for repeated use in a clinical setting. |
| Ergonomics & Compatibility: Meets ISO 3964 (Coupling dimensions), ISO 1797 (Shanks for rotary and oscillating instruments) | The handpiece connects properly to dental motors and accepts standard dental burs. |
| Light Illumination: Meets DIN EN ISO 14457 minimum illuminance (approx. 25,000 Lux) | The fiber optic light system provides adequate illumination of the operating area. |
| Risk Management: ISO 14971 (Application of risk management to medical devices) | Risks associated with the device have been identified, evaluated, and controlled. |
| Usability: IEC 62366-1 (Application of usability engineering) | The device is designed to be safe and effective for use by trained professionals. |
| Processing Information: ISO 17664 (Information to be provided for processing) | The manufacturer provides clear instructions for processing (e.g., cleaning, sterilization) of the device. |
The document states: "Performance bench testing according to international standards for Dental Handpieces has been conducted to determine conformance..." and lists the standards. This implies that the device met the requirements of these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in terms of patient or clinical samples, as this was a non-clinical, bench-testing submission. The "test set" would refer to the physical units of the device tested in the lab. The document describes "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," which implies a sample of devices tested. The exact number is not provided.
- Data provenance: Not explicitly stated regarding origin or type (retrospective/prospective), as it's non-clinical bench testing. The manufacturer, KaVo Dental GmbH, is based in Germany.
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. For a dental handpiece, "ground truth" as it relates to diagnostic accuracy or clinical outcomes is not established by human experts in the same way as for an AI/ML algorithm. Performance is assessed against engineering specifications and international standards through bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., ground truth for image-based diagnostics), which is not relevant for this device.
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
- Not Applicable. This is a mechanical dental instrument, not a diagnostic AI/ML system, and therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a standalone mechanical device. The concept of "algorithm only" or "human-in-the-loop" performance does not apply. The device's "standalone" performance is assessed by its ability to meet the non-clinical performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a dental handpiece, the "ground truth" for performance relates to engineering specifications and international standards. For example, bur extraction force must meet a minimum specified in DIN EN ISO 14457; light illumination must meet DIN EN ISO 14457. Biocompatibility is "ground-truthed" by adherence to ISO 10993 series. There isn't a "pathology" or "outcomes data" ground truth in the same sense as for a diagnostic device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. Not an AI/ML device.
§ 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.