(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.
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Koyoa39
510(k) SUMMARY
| Applicant and Owner | W & H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 BuermoosAustriaTel.: +43-6274-6236-397Fax: +43-6274-6236-234JUL 29 2008 |
|---|---|
| Contact Person | Gabriele Wienbeck |
| Date of Preparation | 21.03.2008 |
| Device Name | Surgical straight handpiece SI-11 LED GSurgical contra-angle handpiece WI-75 LEDMikro saw handpieces S-8 R, S-8 O, S-8 S |
| Classification Name | Handpiece, rotary bone cutting |
| Regulation Number | 21 CFR872.4120 |
| Product Code | KMW |
| Predicate Device | Surgical contra-angle handpieces, K011061Saw handpieces K052741 |
| Device Description | Surgical handpieces and Mikro saw handpieces havebeen designed to transmit the rotational movement of themotor axle to the shank of a bur or a saw blade whichwill be inserted into the output end of the handpiece.They fit all surgical drive units and surgical motors with acoupling system according to ISO 3964.The user manual points out the recommendations for thedifferent handpiece types covered by this application. |
| Intended Use: | Surgical treatment of dental hard tissue in oral andmaxillo-facial surgery |
| TechnologicalCharacteristics | The Surgical contra-angle handpieces representsrevised versions of the predicate device. The maintechnical characteristics have been retained unchanged.New : The redesigned handpieces contain their ownintegrated generator to provide LED light to the operatingarea. |
| Comparison of thedevice to thepredicate device | The intended use, technological characteristics,performance parameter and material are very similar tothe predicate device.The devices are substancially equivalent to the predicatedevices. |
| Performance Testing | Bench testing results demonstrate substanciallyequivalence |
| Clinical Testing | Clinical data were not needed for this modification. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gabriele Wienbeck Regulatory Affairs W&H Dentalwerk Buermoos GmbH Ignaz-Glaser-Straße 53 P.O. Box 1, 5111 Bürmoos AUSTRIA
JUL 2 9 2008
Re: K080939
Trade/Device Name: Surgical Handpieces and Mikro Saw Handpieces Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: KMW Dated: June 25, 2008 Received: July 21, 2008
Dear Ms. Wienbeck:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Wienbeck
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Khmuele-Lending for //
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
510(k) (if known): K080939
Device Name: Surgical handpieces and Mikro saw handpieces
Indication for Use:
Surgical treatment of dental hard tissue in oral and maxillo-facial surgery
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over- The -Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Roane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080939
§ 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.