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The JETSONIC 2000 combines both scaling and airpolishing functions in one The 62100110 2000 wers all prophylaxis needs. The airpolishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler michaed to be used to be used for for fast and reliable removal of light to heavy calculus and plaque. Carculus and plaque. Device applications: Routine oral prophylaxis , routine polishing especially hard to Device applications. It enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets

The JETSONIC 2000 combines both scaling and airpolishing functions in one

Based on the provided text, the document is a 510(k) clearance letter for a dental device, the "JetSonic 2000." This letter indicates that the device has been found substantially equivalent to a predicate device, which allows it to be marketed.

However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC or standalone).

The text describes the device's indications for use:

• Airpolishing function: intended to remove stubborn stains, plaque, and soft debris.
• Scaler function: intended for fast and reliable removal of light to heavy calculus and plaque.
• Device applications: Routine oral prophylaxis, routine polishing especially hard to clean areas, enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets.

Since the device received 510(k) clearance based on substantial equivalence, the "study" that proves it meets acceptance criteria is primarily a comparison to a legally marketed predicate device, demonstrating that it has similar technological characteristics and is as safe and effective. The FDA's letter states: "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..."

Therefore, I cannot fill out the requested table or answer the specific questions about studies, sample sizes, ground truth, experts, or comparative effectiveness, as this information is not present in the provided document.

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This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubbern stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.

Jetsonic 2000 combines both ultrasonic scalling and air polishing functions in one compact unt that answers all prophylaxis needs.

I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Jetsonic 2000 Ultrasonic Scaler and Air Polishing Unit). It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device. However, it does not include details about device performance metrics, clinical studies, sample sizes, expert involvement, or ground truth establishment.

Ask a specific question about this device