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DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, one-piece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

DTX Studio design is a stand-alone software platform that integrates CAD software to render a design of a dental abutment. The software receives surface scan data containing topographical characteristics of real teeth, position and orientation of implants and uses also an integrated third-party software to perform the CAD design of the dental abutment. Additional functions include creating and tracking cases. The output of the device is a computer file containing the dental abutment in a digital form.

I am sorry, but the provided text from the FDA 510(k) K181932 submission for "DTX Studio design" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria.

The document primarily focuses on:

• The FDA's letter confirming substantial equivalence.
• The Indications for Use.
• A comparison table between the subject device (DTX Studio design), a primary predicate device (3Shape Abutment Designer Software), and a reference predicate device (previous DTX Studio design K171466).
• A brief discussion of the comparison.
• A general statement about performance data, noting that the device was designed under Quality System Regulations (21 CFR § 820, ISO 13485:2016), conforms to EN IEC 62304:2006, and underwent design control activities including risk management (ISO 14971:2012) and verification/validation testing per FDA guidance.

It explicitly states: "This documentation includes testing which demonstrates that the requirements for the features have been met." However, it does not provide the specifics of:

1. A table of acceptance criteria and the reported device performance: This is not present in the document.
2. Sample size, data provenance, number of experts, qualifications, and adjudication methods for the test set: These details are not mentioned.
3. Whether MRMC comparative effectiveness studies were done, or specific effect sizes: Not discussed. The device is CAD software, not an AI for diagnostic imaging interpretation in the traditional sense that would typically involve MRMC studies for reader performance improvement.
4. Whether standalone (algorithm only) performance was done: While it's software, the performance data section is very general and doesn't specify standalone performance metrics.
5. Type of ground truth used: Not specified.
6. Sample size for the training set: Not mentioned.
7. How ground truth for the training set was established: Not mentioned.

The information provided is typical for a 510(k) summary, which generally aims to demonstrate substantial equivalence to a predicate device rather than providing the granular detail of a comprehensive clinical study report or a detailed V&V report for software. For such detailed performance data, one would typically need access to the full 510(k) submission and supporting documentation, which is not usually made public in this summarized format.

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