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3Shape Implant Studio is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation of patient anatomy and dental implant placement.

Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.

3Shape Implant Studio® is a stand-alone software device used to pre-operatively plan the placement of a dental implant based on the visualization of a patient's CT image, optionally aligned to an optical 3D surface scan. A virtual surgical quide can be designed and then exported to an external system for manufacturing.

The device has no patient contact being a software only device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3Shape Implant Studio, structured as requested:

Acceptance Criteria and Device Performance Study for 3Shape Implant Studio (K202256)

Unfortunately, the provided text does not include a detailed table of acceptance criteria with reported device performance metrics. It mentions that "Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria," and that "All test results have been reviewed and approved, showing 3Shape Implant Studio® to be substantially equivalent in safety and effectiveness to the primary predicate device." However, specific numerical targets or the device's performance against those targets are not present within this document.

Therefore, the following sections will address what information is available and highlight what is missing.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify the sample size used for either verification or validation testing.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions that the software "reads imaging information output from medical scanners such as CT and optical scanners" and visualizes "an imported CT image from DICOM data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication Method for the Test Set

• The document does not provide any information regarding an adjudication method for the test set.

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

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
• The device is described as an "implant planning and surgery planning software tool" intended for use by "dental professionals." It is a tool for pre-operative simulation and planning, rather than an AI-driven diagnostic or interpretative tool that would typically involve human-in-the-loop performance studies as described.

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

• Yes, the performance testing appears to be a standalone (algorithm only) assessment. The document states, "Software, hardware, and integration verification and validation testing was performed." The focus is on the software's functionality in terms of processing imaging data, enabling planning, and designing surgical guides, not on how human users perform with or without the software. The "summative evaluation" mentioned could potentially involve human interaction to assess usability but the performance itself is described as the software's inherent capabilities.

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

• The document does not explicitly state the type of ground truth used. Given the nature of an implant planning software, the "ground truth" would likely relate to the accuracy of 3D reconstructions, measurements, planning parameters, and the fit/design of surgical guides. This would typically be established by expert dental professionals using established anatomical references, CAD/CAM standards, and potentially phantom models. However, this is inferred, not stated.

8. The sample size for the training set

• The document does not mention a training set. This is because the 3Shape Implant Studio is described as software that allows pre-operative simulation and evaluation based on imported scan data, and is used for designing surgical guides. It is not presented as a machine learning or AI algorithm that implicitly learns from a dataset (i.e., it doesn't appear to be a 'learning' algorithm in the sense that it requires a training set for model development). It is a CAD design and visualization tool.

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

• As the document does not mention a training set (see point 8), there is no information on how its ground truth would have been established.

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Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.

Implant Studio™ is a software only device used to pre-operatively plan the placement of a dental implant and to visualize a patient's CT image, optionally aligned to an optical 3D surface data. Virtual crown(s) can be used to guide the planning under the final prosthetic aspect. The surgical quide data can be designed then exported to an external system for manufacturing.

The device has no patient contact.

The provided document is a 510(k) summary for a medical device called Implant Studio™ 2015-1. It describes the device, its intended use, and comparison to predicate devices, but it does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.

The document discusses "verification and validation testing" with "approved acceptance criteria" but does not provide the criteria themselves, nor the specific results demonstrating performance against these criteria. It states that "clinical testing is not a requirement and has not been performed."

Therefore, based on the information provided, I cannot fulfill all parts of your request. I will extract the available information.

1. A table of acceptance criteria and the reported device performance

The document states:

"Prior to release, verification and validation testing of the Implant Studio 2015-1 has been completed using the approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues reported by beta partners must be reviewed and handled appropriately."

However, the specific "acceptance criteria" (e.g., accuracy, precision, sensitivity, specificity) and the reported device performance metrics against these criteria are not detailed or provided in the given text. The document concludes that "All test results have been reviewed and approved, showing the Implant Studio to be substantially equivalent in safety and effectiveness to the predicate," but offers no quantitative data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document primarily focuses on software verification and validation, rather than a clinical performance study involving expert assessment of data.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing is not a requirement and has not been performed." The device is a "medical front-end software" for planning and visualization, not an AI diagnostic tool requiring MRMC studies for reader improvement.

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

The document mentions "software, hardware, and integration verification and validation testing" to ensure the software "functions as intended." However, it does not describe a standalone performance study in terms of clinical outcomes or specific performance metrics (e.g., accuracy of implant placement prediction) for the algorithm itself. It is a "pre-operative planning software" and relies on human professionals for its use.

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

The document does not detail the specific "ground truth" used for testing beyond stating that "each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria." This implies internal testing against defined requirements rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not provided in the document. The device is a software for planning and visualization, and while it processes medical images, the document does not indicate that it is an AI/ML device that requires a "training set" in the context of typical AI model development.

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

This information is not provided in the document, as there's no mention of a "training set" or AI model training.

Ask a specific question about this device

Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.

Implant Studio™ is a software only device used to pre-operatively plan the placement of a dental implant and to visualize a patient's CT image, optionally aligned to an optical 3D surface data. Virtual crown(s) can be used to quide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing.

The device has no patient contact.

The provided text describes the 3Shape Implant Studio, a medical planning software. However, it does not contain a detailed study with acceptance criteria and reported device performance in a table format.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Prior to release, verification and validation testing of the Implant Studio has been completed using the approved acceptance criteria: Each user need has its own validation acceptance criteria: each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues reported by beta partners must be reviewed and handled appropriately."

However, no specific quantitative acceptance criteria or corresponding reported device performance metrics are provided in a table or any other format within the given text. It mentions that "All test results have been reviewed and approved, showing the Implant Studio to be substantially equivalent in safety and effectiveness to the predicate," but lacks concrete data.

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

• Sample size: Not specified.
• Data provenance: Not specified. The document only mentions "bug verification consists in ensuring issue is not reproducible; issues reported by beta partners must be reviewed and handled appropriately," which suggests some testing with external users, but the origin or nature of the data involved is not detailed.

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

This information is not provided. The text does not detail how ground truth was established for any internal testing or beta testing.

4. Adjudication method for the test set:

Not specified.

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:

No MRMC study was mentioned. The document focuses on the software as a planning tool, not as an AI-assissted diagnostic or interpretive device.

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

The device is described as "software only device used to pre-operatively plan the placement of a dental implant and to visualize a patient's CT image... The guide can be used for aiding the placement of the implant(s) to the intended position(s)." It appears to be an algorithm-only device for planning, but its performance is not explicitly presented as a standalone study result. The "use of the software requires that the user has the necessary medical training in implantology and surgical dentistry," indicating a human-in-the-loop for the overall process, even if the planning itself is algorithmically driven. However, there's no standalone performance study reported.

7. The type of ground truth used:

Not specified in the provided text.

8. The sample size for the training set:

The document does not mention a "training set" in the context of machine learning or AI. It refers to a "planning phase" and "library files," but no training data for an algorithm is described.

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

This information is not applicable as no training set is discussed. The "implant and sleeve library files are provided via encrypted library files which are generated by 3Shape and approved by the corresponding original manufactures," suggesting pre-defined data rather than a learned model.

In summary, the provided FDA 510(k) summary focuses on establishing substantial equivalence to predicate devices and describes the software's intended use, technological characteristics, and verification/validation processes. However, it does not include the specific quantitative acceptance criteria, detailed study designs, sample sizes, or ground truth establishment methods that would fully answer the questions posed. The nonclinical testing section broadly states that "verification and validation testing... has been completed using the approved acceptance criteria," but these criteria and their results are not explicitly detailed. The document also explicitly states: "Clinical testing is not a requirement and has not been performed."

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