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Indications are very widespread in the field of oral surgery ranging from

• A. Implant placement, including
  • 1. preparation of the osteotomy site
  • 2. bone recontouring, osteoplasty
• B. Bone grafting
  • 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
  • 2. harvesting autogen living bone
  • 3. sinus elevation & grafting of alveolar sockets
• C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
• D. Periodontal surgeries
  • 1. bone recontouring & alveoplasty around living teeth
  • 2. removal of exostosis
• E. Endodontic treatment

Intracanal preparations using rotating NiTi-files.

Surgical Contra-Angle Handpieces Types 975 AE. 979 E/KM. 985 AE. 986 AE, 988 E/KM Surgical Straight Handpieces Types S 11, SL 11

This document is a 510(k) clearance letter from the FDA for several models of "Surgical Contra-Angle Handpieces" and "Surgical Straight Handpieces." It declares the devices "substantially equivalent" to predicate devices, allowing them to be marketed.

Crucially, this document is an approval letter, not a study report. It does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on a demonstration of substantial equivalence to a legally marketed predicate device, rather than through a new clinical trial or performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. The document simply confirms the FDA's decision to allow the devices to be marketed.

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The design of the S-53 is virtually identical to the comparative devices which are listed and displayed in Exhibits 2 and 3.

This document, "Exhibit 9: 510(k) Summary," is a regulatory filing for a medical device called the "S-53 Video Imaging System." It aims to demonstrate substantial equivalence to previously cleared devices.

Crucially, this document is a summary statement for a 510(k) premarket notification. It does not provide a study to prove the device meets acceptance criteria in the way a clinical trial report or a performance validation study would. Instead, it asserts substantial equivalence based on design, technology, specifications, and intended use being "virtually identical" or "very similar" to predicate devices.

Therefore, I cannot fulfill most of your request directly from the provided text, as the information you're asking for (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) is typically found in detailed performance studies, not in a 510(k) summary claiming substantial equivalence.

Here's what can be inferred or stated based on the provided text, and where the requested information is not available:

1. Table of acceptance criteria and reported device performance:

   • Not available in the provided text. This document does not present specific performance metrics or acceptance criteria for the S-53 Video Imaging System. It relies on the premise that its performance is implicitly acceptable because it's "virtually identical" to pre-existing, legally marketed devices.

2. Sample size used for the test set and the data provenance:

   • Not available in the provided text. No test set or associated data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not available. No new ground truth establishment is described in this summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not available. No test set or adjudication process is mentioned.

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/Not available. This device is a "Video Imaging System" and there is no indication of AI assistance or MRMC studies for reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable/Not available. This device is an imaging system, not an algorithm, and no standalone performance study is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Not available. No ground truth for new performance validation is discussed.

8. The sample size for the training set:

   • Not applicable/Not available. This summary does not describe an AI/algorithm that would require a training set.

9. How the ground truth for the training set was established:

   • Not applicable/Not available. As above, no training set is discussed.

Summary based on the provided text:

The provided document is a 510(k) Summary for the "S-53 Video Imaging System." Its purpose is to argue for substantial equivalence to predicate devices such as the Fuji Optical Systems-Dentacam, New Image-Accucam, and other listed devices (IDT, Welch Allyn, Dentsply, Air Technologies).

The core argument for substantial equivalence is based on:

• Design: "virtually identical to the comparative devices"
• Technology: "virtually identical"
• Specifications: "very similar"
• Intended Use: "the same"

The document asserts that "minor differences have no impact on the safe use and/or effectiveness of the device," thereby implying the S-53 meets the same level of safety and effectiveness as the predicate devices without needing a separate, detailed performance study with new acceptance criteria or ground truth establishment. The wide commercial distribution and "safe use" of similar devices are also cited as supporting evidence.

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