(141 days)
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- Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys.
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- Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate).
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- Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally.
- Porcelain etch substitute: for preparation of intaglio surface of porcelain 4. restorations in place of etching with hydrofluoric acid in the mouth.
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- Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate).
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- Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above.
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- Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration.
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- Endodontic post preparation : for preparation of endo post to enhance micromechanical bond of post to prepared tooth.
- Denture repairs: for preparation of denture base to facilitate repairs. 9.
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- Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before rebonding. For enhancement of adhesive to tooth structure.
ACCU-PREP is virtually identical to the MICROETCHER in design and function. The two models of the device, Type I and Type II are identical in design and function but differ cosmetically. That is Type I is nearly identical to the MICROETCHER and Type II is esthetically more pleasing. In addition, Type II has the abrasive reservoir in the center of the handpiece as opposed to the back end as in the MICROETCHER and it is completely autoclavable. The ACCU-PREP operates at somewhat lower minimum pressure than the MICROETCHER. 40 psig as opposed to 60.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence | "Functionally identical to the predicate device" |
| Shear Bond Strength | "No statistically significant difference was found" in shear bond tests (p ≥ 0.05) compared to the predicate device. |
| Surface Abrasion Characteristics | "Examination of abraded surfaces using Scanning Electron Microscopy showed virtually identical results" compared to the predicate device. |
| Material/Abrasive Compatibility | Both devices "employ 50 um aluminum oxide as the primary abrasive but other grits can be used where appropriate. The range of normal grit sizes is 0.05 to 90 um" |
| Intended Uses | The ACCU-PREP is intended for a range of dental applications, with no specific performance metrics stated for each individual indication beyond functional equivalence to the predicate. |
| Aesthetic Difference | Type I is "nearly identical" to the predicate, and Type II is "esthetically more pleasing." (This is a design difference, not a functional performance criterion per se, but noted as a key distinction). |
| Operating Pressure | ACCU-PREP "operates at somewhat lower minimum pressure than the MICROETCHER. 40 psig as opposed to 60." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "Shear bond tests were performed on human extracted teeth." However, the exact sample size (number of teeth) is not specified.
- Data Provenance:
- Country of Origin: Not specified, but implied to be in the US where BISCO, Inc. is located.
- Retrospective or Prospective: Not explicitly stated, but the description of performing "Shear bond tests" and "Examination of abraded surfaces using Scanning Electron Microscopy" suggests a prospective experimental study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The study was conducted by James L. Sandrik, Ph.D., who is the Director of Technical Affairs at Bisco, Inc. While he authored the report and implicitly oversaw the testing, it's not clear if he or other external experts established a formal "ground truth" for the test results outside of standard scientific measurement and comparison.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The study involved objective measurements (shear bond strength, SEM imaging) and direct comparison to a predicate device, rather than subjective interpretation requiring adjudication among multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done?: No. This type of study is typically performed for diagnostic devices where human interpretation of images or other data is central to the device's function. The ACCU-PREP is a dental abrading device, and its performance is evaluated through material science and mechanical testing, not human-in-the-loop diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done?: Yes, in essence. The performance tests (shear bond, SEM) evaluated the device's physical effects and functional output directly, without ongoing human intervention in the operation of the device during the test or interpretation of the results in a human-in-the-loop fashion. The comparison was device-to-device.
7. Type of Ground Truth Used:
- Ground Truth Type:
- Predicate Device Performance: The primary "ground truth" or reference point was the established performance of the legally marketed predicate device, MICROETCHER, in terms of shear bond strength and surface morphology.
- Objective Measurements: Shear bond tests (quantifying mechanical strength) and Scanning Electron Microscopy (visualizing surface characteristics) provided objective data for comparison.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a physical tool, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”