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K Number
K962979
Device Name
S-53 INTRORAL DENTAL SYSTEM
Manufacturer
DEL MEDICAL SYSTEMS CORP.
Date Cleared
1996-09-25

(56 days)

Product Code
DZA
Regulation Number
872.4130
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

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

AI/ML Overview

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.

§ 872.4130 Intraoral dental drill.

(a)
Identification. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.