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510(k) Data Aggregation
(567 days)
Implanter incl. Accessories
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.
The provided text is a 510(k) Summary for a medical device called "Implanter incl. Accessories." It details the device's indications for use, comparisons to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence.
However, the document states, "No clinical data is needed to demonstrate substantial equivalence." This means there was no study conducted to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them in the format requested, as that type of study was explicitly not conducted or deemed necessary for this 510(k) submission.
The document focuses on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through non-clinical testing, rather than proving a specific performance level of a novel AI algorithm.
Below is a breakdown of the information that is available in the provided text, focusing on the nearest equivalents to your requested points:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission focused on substantial equivalence through non-clinical testing, there are no specific performance acceptance criteria like sensitivity/specificity or reader improvement from an AI study. Instead, the acceptance criteria are implicit in the conformity to established medical device standards and FDA guidance documents and the demonstration that technological differences do not impact safety or effectiveness compared to the predicate device.
The "reported device performance" is demonstrated through the satisfactory completion of these non-clinical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformity with IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Demonstrated conformity with IEC 60601-1. |
| Conformity with IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromaqnetic compatibility) | Demonstrated conformity with IEC 60601-1-2. |
| Handpiece function and lifecycle according to ISO 14457:2017 (Dentistry-Handpieces and Motors) | Verified handpiece function and lifecycle according to ISO 14457:2017. |
| Software validation in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and FDA Guidance for a MODERATE level of concern. | Validated software for the device and its foot control in conformity with IEC 62304 and FDA Guidance (MODERATE level of concern). |
| Thermal safety in conformity with IEC 62471:2004 (Photobiological safety of lamps and lamp systems) | Verified thermal safety in conformity with IEC 62471:2004. |
| Biocompatibility of patient contacting components according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 7405. | Evaluated biocompatibility of patient contacting components according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 7405. For differences in motor and handpiece materials, testing per ISO 10993 addresses potential concerns. |
| Conformity with IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems). | Verified conformity with IEC 60601-1-1. |
| Reprocessing (Cleaning, Sterilization) validation according to FDA Guidance titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". | Validated reprocessing (Cleaning, Sterilization). Differences in cleaning methods were deemed not to affect substantial equivalence according to validation. Sterilization cycle parameters for dynamic-air-removal were identical to the predicate device. |
| Conformity with FDA Guidance on Dental Handpieces titled "Dental Handpieces – Premarket Notification [510(k)] Submissions". | Verified conformity with FDA Guidance on Dental Handpieces. |
| The technological characteristic differences between the proposed device and the predicate device do not affect the substantial equivalence and do not raise new risks. (e.g., higher mechanical output power, lower motor torque, different number of programs, wired vs. wireless foot control for predicate) | Performance testing was conducted to address differences. For instance, the higher mechanical output power (120W vs 80W predicate) was deemed not to lead to negative effects due to constructive power reserves (small difference in motor torque). The differing number of programs were supported by performance testing. The wired foot control (versus wireless on predicate) was resolved by noting the reference device used a wired control. Changes in motor and handpiece materials were addressed by ISO 10993 testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical, likely bench testing performed by the manufacturer (Guilin Woodpecker Medical Instrument Co., Ltd. in China) or a contracted lab. Details on specific sample sizes for each non-clinical test (e.g., how many handpieces were tested for lifecycle, how many components for biocompatibility) are not included in this summary.
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)
This information is not applicable/not provided. The device is an "Implanter incl. Accessories" (a dental handpiece and motor system), not an AI diagnostic imaging device. Therefore, there is no "ground truth" established by clinical experts in the context of diagnostic interpretation. The "ground truth" for non-clinical testing refers to established engineering standards, physical measurements, and chemical analyses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies among multiple human readers in a clinical study involving subjective interpretation. Since this is non-clinical testing of a physical medical device, such an adjudication method is not relevant.
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
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data is needed to demonstrate substantial equivalence." This type of study is relevant for AI-powered diagnostic aids, which this device is not. It is a mechanical dental instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This device is a mechanical dental instrument, not an AI algorithm. Its performance is inherent in its physical and functional specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the clinical diagnostic sense (like expert consensus or pathology for imaging) is not applicable here. The "ground truth" for this device's non-clinical testing refers to:
- Established national and international engineering standards (e.g., IEC 60601-1, ISO 14457, IEC 62304, ISO 10993 series, IEC 62471).
- FDA guidance documents specific to medical electrical equipment, software, biocompatibility, reprocessing, and dental handpieces.
- Objective physical and chemical measurements (e.g., power output, torque, speed range, material composition analysis, sterilization efficacy, electromagnetic compatibility).
8. The sample size for the training set
This information is not applicable/not provided. This device is a mechanical medical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. Since there is no AI model or training set, there is no ground truth established for a training set.
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