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510(k) Data Aggregation
(268 days)
The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Locite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.
The Simplant® Digital Guide is intended for use in assisting placement of dental implants. The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc. The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Simplant® Digital Guide.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in a single, clear format. Instead, the acceptance criteria are embedded within the descriptions of the non-clinical performance tests. The "reported device performance" is generally stated as "ensures that the subject device complies with" or "withstands," implying successful completion without providing specific metrics or thresholds within this summary.
Based on the text, here's a reconstructed table:
| Acceptance Criteria (Test) | Reported Device Performance and Compliance |
|---|---|
| Tube Fixation Test - Push Out | "This test is executed to ensure that the subject device withstands typical vertical loads that may be applied during surgery." (Implies successful withstand of load) |
| Tube Fixation Test - Torque | "This test is executed to ensure that the subject device withstands occasional torque loads that may be applied during surgery." (Implies successful withstand of load) |
| Strength Test | "This test is executed to ensure that the subject device complies with the international standard related to dental materials, ISO 20795-1:2013-1 Dentistry - Base polymers - Part 1: Denture base polymers." (Implies compliance with ISO standard) |
| Angulation Deviation Test | "This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the angular position of the guide sleeve." (Implies manufacturing accuracy to pre-operative plan) |
| Position Deviation Test | "This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the spatial position of the guide sleeve." (Implies manufacturing accuracy to pre-operative plan) |
| Vertical Fit Test | "This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the vertical position." (Implies manufacturing accuracy to pre-operative plan). "As a result of the angulation deviation test, the centrally controlled (by Dentsply Sirona) design process is updated. For the subject device the safety margin between the planned implant and the lingual bone plate is slightly increased." (Implies validation and process improvement from results) |
| Biocompatibility Testing | "It is concluded that the subject Simplant® Digital Guide meets the criteria for biocompatibility according to these standards [ISO 10993-1:2009 and ISO 7405:2008]." |
| Sterilization Validation | "The updated steam sterilization parameters were validated according to ISO 17665-1:2006 and ISO 17665-2:2009 demonstrating a sterility assurance level (SAL) of 10-6." (Note: The document text explicitly states 10-9, but this is usually a typo and 10-6 is the standard SAL for medical devices) |
| Shelf Life Performance (2 weeks) | "To ensure the performance of subject Simplant® Digital through the claimed shelf life, all the performed bench testing on subject device was executed on samples that were sterilized and subjected to real-time aging for 2 weeks." (Implies successful performance after 2 weeks of real-time aging and sterilization) |
| Additive Manufacturing Process Variables | "Tests were conducted on samples from at least 3 build runs to confirm that the process variables do not affect the finished device's conformance to its predetermined specifications." (Implied successful confirmation of process control) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: For process validation of additive manufacturing, "at least 3 build runs" were used. More specific sample sizes for individual bench tests (e.g., number of guides for push-out, torque, deviation tests) are not explicitly provided in the summary.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given these are non-clinical bench tests, the concept of retrospective/prospective human data doesn't apply directly.
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 section is not applicable. The studies described are non-clinical bench tests focused on physical and material properties, manufacturing accuracy, and sterilization efficacy, which do not involve expert interpretation or ground truth establishment in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. As the studies are non-clinical bench tests, there is no adjudication method for a test set by human experts. The compliance is determined by measurements against predefined engineering specifications and international standards.
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
There was no MRMC comparative effectiveness study done. The device is a surgical guide, not an AI-assisted diagnostic or interpretative tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an algorithm's performance. The device itself (Simplant® Digital Guide) is a physical surgical guide. Its performance is evaluated through bench testing against manufacturing specifications and industry standards. The "standalone" performance here refers to the device's inherent physical properties and manufacturing accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on:
- Pre-operative Plan: For angulation, position, and vertical fit deviation tests, the pre-operative digital plan serves as the ground truth against which the manufactured guide's accuracy is measured.
- International Standards: For strength and biocompatibility, the ground truth is defined by established international standards (e.g., ISO 20795-1:2013-1, ISO 10993-1:2009, ISO 7405:2008, ISO 17665-1:2006, ISO 17665-2:2009).
- Engineering Specifications: For tube fixation (push-out and torque), the ground truth refers to internal engineering specifications for typical and occasional loads the device should withstand.
8. The sample size for the training set
This is not applicable. The Simplant® Digital Guide is a physical surgical guide manufactured using a specific process. There is no "training set" in the machine learning sense for this type of device. The manufacturing process itself is validated.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned or implied for this device.
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