(117 days)
Surgical treatment of dental hard tissue in oral and maxillo-facial surgery
Surgical handpieces and Mikro saw handpieces have been designed to transmit the rotational movement of the motor axle to the shank of a bur or a saw blade which will be inserted into the output end of the handpiece. They fit all surgical drive units and surgical motors with a coupling system according to ISO 3964. The user manual points out the recommendations for the different handpiece types covered by this application.
Here's an analysis of the provided text regarding the acceptance criteria and study for the W&H Dentalwerk Buermoos GmbH surgical handpieces:
It's important to note that the provided document is a 510(k) summary for a dental surgical handpiece, which is a mechanical device. The information requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set, etc.) is primarily relevant for AI/ML-based medical devices or diagnostic tools that involve interpreting data or images.
For a mechanical device like a surgical handpiece, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on bench testing to ensure mechanical, electrical, and material performance, as well as safety and effectiveness compared to a predicate device. There is no AI/ML component to this device.
Therefore, many of the requested fields cannot be directly answered from the provided text, as they are not applicable to the type of device being described.
Here's a breakdown of what can be extracted and what cannot:
Device: Surgical straight handpiece SI-11 LED G, Surgical contra-angle handpiece WI-75 LED, Mikro saw handpieces S-8 R, S-8 O, S-8 S
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: |
- Transmits rotational movement of motor axle.
- Accommodates burs/saw blades.
- Fits surgical drive units/motors according to ISO 3964.
- Maintains intended use (surgical treatment of dental hard tissue).
- Comparable technological characteristics.
- Comparable performance parameters.
- Comparable materials. | Bench testing results demonstrate substantial equivalence.
- "Surgical handpieces and Mikro saw handpieces have been designed to transmit the rotational movement of the motor axle to the shank of a bur or a saw blade which will be inserted into the output end of the handpiece."
- "They fit all surgical drive units and surgical motors with a coupling system according to ISO 3964."
- Intended Use: "Surgical treatment of dental hard tissue in oral and maxillo-facial surgery" (identical to predicate's scope, implying functional equivalence for this purpose).
- "The main technical characteristics have been retained unchanged" compared to the predicate, with the addition of an integrated LED generator.
- "The intended use, technological characteristics, performance parameter and material are very similar to the predicate device." |
| Safety: - Safe operation (implied by regulatory compliance).
- Compatibility with general controls provisions of the Act. | The device obtained 510(k) clearance, indicating FDA's determination of substantial equivalence, which includes an assessment of safety and effectiveness relative to the predicate. Compliance with general controls and GMP is expected. |
| New Feature Performance (LED light): - Integrated generator provides LED light to the operating area. | "The redesigned handpieces contain their own integrated generator to provide LED light to the operating area." (Performance is described as simply providing the light, presumably effectively for its purpose.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. For a mechanical device, "sample size" and "data provenance" in the context of a "test set" (as typically understood for AI/ML) are not relevant. Performance was assessed via bench testing, which involves physical testing of the device prototypes/samples. The specific number of physical units tested is not provided, nor is the "country of origin of data" in this context.
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. This device does not involve a "ground truth" established by experts in the diagnostic sense. The performance evaluation is based on engineering principles and physical measurements from bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No expert adjudication method was employed as there is no diagnostic output requiring such a process.
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 surgical tool, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Engineering Standards & Predicate Comparison. The "ground truth" for this type of device is adherence to engineering specifications, performance parameters validated through bench testing, and demonstrating substantial equivalence to the legally marketed predicate device(s).
8. The sample size for the training set
- Not Applicable. This device does not have a "training set" as it does not involve machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
In summary, the provided document details the 510(k) clearance for a mechanical dental surgical handpiece. The "acceptance criteria" and "study" described are typical for such devices, primarily relying on bench testing to demonstrate performance and substantial equivalence to existing predicate devices, particularly regarding mechanical function, material compatibility, and safety. The questions posed in the prompt are almost entirely tailored to AI/ML-based diagnostic devices and, therefore, do not align with the nature of this product.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.