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DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

DentMix VPS Impression Material is an addition-reaction base/catalyst polyviny/siloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

The provided document describes the substantial equivalence determination for the "DentMix VPS Impression Material" (K223892) by comparing it to a predicate device, "Elements™" (K151150). The acceptance criteria are based on meeting or exceeding the performance of the predicate device across various physical properties, typically measured against recognized standards like ISO 4823-2015.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

A direct table of "acceptance criteria" is not explicitly stated as distinct from the predicate device's performance. Instead, the study aims to show that the subject device performs at least as well as the predicate device. Therefore, the predicate device's performance serves as the de facto acceptance benchmark.

Note on "Acceptance Criteria": For each of these properties, the acceptance criterion implicitly is that the DentMix VPS Impression Material is functionally equivalent to or performs within an acceptable range compared to the predicate device, often guided by the ISO 4823-2015 standard. "PASS" explicitly indicates meeting a standard. For numerical values, the goal is typically to be similar or better.

Study Details for DentMix VPS Impression Material

The document outlines a comparison study to demonstrate substantial equivalence, primarily focusing on physical properties.

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

   • The document does not explicitly state the numerical "sample size" for each test point (e.g., number of specimens tested for consistency, working time, etc.). However, the values reported for "Linear Dimensional Change," "Elastic Recovery," and "Strain-In-Compression" include standard deviations (e.g., "0.14% (0.01)"), which implies that multiple measurements were taken to calculate an average and variability.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It presents the results as part of a 510(k) submission by IPB Inc.

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

   • This type of detail (number and qualifications of experts) is typically associated with clinical studies or studies where human interpretation or consensus is required (e.g., image analysis). For material property testing as performed here, the "ground truth" is established by direct measurement of physical properties according to standardized test methods (e.g., those described in ISO 4823-2015). Experts in material science or dentistry might design and oversee these tests, but their "consensus" is not the ground truth in the same way it would be for diagnosing a medical image.

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

   • Adjudication methods (e.g., 2+1) are relevant for studies involving human interpretation and potential disagreement (e.g., reading medical images). For physical property testing of dental impression materials, direct measurements are taken, and typically, there is no "adjudication" in this sense. Quality control and adherence to standard protocols ensure reliability.

4. 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, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for evaluating a dental impression material, as it's a diagnostic tool comparison for medical imaging interpretation, not a material property evaluation.

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

   • This question is also not applicable. The device is a physical dental impression material, not an algorithm or AI system. The performance evaluated is the inherent physical properties of the material itself.

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

   • The "ground truth" for the performance evaluation in this context is the results of standardized physical property tests as defined by recognized standards (specifically ISO 4823-2015). This is a direct measurement of material characteristics against objective criteria, not based on human consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • This concept is not applicable. The evaluation is a direct comparison of physical material properties against a predicate, not a machine learning model that requires a "training set."

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

   • Not applicable, as there is no training set for this type of device evaluation.

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The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The PrimeLOC Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) to serve in a similar function to LOCATOR® abutments for resilient attachment of prostheses to endosseous dental implants. All PrimeLOC abutments are made of titanium alloy and have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. The PrimeLOC Attachment System is designed to accommodate a path of insertion divergence of up to 20° per implant and no more than 40° of divergence between implants. PrimeLOC abutments are provided with a titanium nitride (TiN) coating and are available in cuff heights up to 6 mm, with an implant interface diameter of 3.5 mm. Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate. A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process. This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.

The provided text describes the 510(k) summary for the PrimeLOC Attachment System, a dental device. It outlines the device's administrative information, classification, predicate devices, indications for use, description, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does not contain information about "acceptance criteria" and how the device's performance measured against those criteria in a structured, quantitative table, as would be typical for an AI/ML medical device submission. The performance data section describes non-clinical testing for areas like sterilization, biocompatibility, mechanical testing (dynamic loading, removal force), and MRI compatibility. It does not mention any clinical study involving a test dataset, ground truth established by experts, or metrics like accuracy, sensitivity, or specificity that would be relevant for an AI/ML device in the context of an "acceptance criteria" table.

Therefore, I cannot fulfill parts 1-9 of your request as the information is not present in the provided document. The document describes a traditional medical device (dental attachment system) clearance, not an AI/ML device that would typically involve the type of study design and data points you're asking about.

To answer your request based on the provided document, the following points are addressable:

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

• Not Applicable. The document describes non-clinical performance characteristics (sterilization, biocompatibility, mechanical properties) and demonstrates substantial equivalence to a predicate device. It does not present quantitative acceptance criteria for clinical performance in the manner of an AI/ML device (e.g., accuracy, sensitivity, specificity) against a test set. The "Performance Data" section discusses:
  • Sterilization validation (ISO 17665-1, ISO 17665-2)
  • Biocompatibility testing (ISO 10993-5, ISO 10993-12)
  • Mechanical testing (ISO 14801 for dynamic loading; testing removal force of retention insert)
  • Non-clinical worst-case MRI review (using scientific rationale and published literature)

Regarding the study that proves the device meets "acceptance criteria" (interpreting "acceptance criteria" in the context of this traditional device as demonstrating substantial equivalence through non-clinical testing):

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

• Not Applicable/Not Provided. The performance data mentioned are non-clinical tests (e.g., sterilization, biocompatibility, mechanical testing). These are laboratory/benchtop tests, not a clinical "test set" in the context of patient data for an AI/ML algorithm. The document does not specify typical sample sizes for these tests (e.g., how many abutments were tested for removal force), nor data provenance (as it's not patient-derived data).

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):

• Not Applicable. This is not an AI/ML device where expert radiologists or similar professionals would establish ground truth for a test set. The "ground truth" for the non-clinical tests would be the established standards for sterilization, biocompatibility, and mechanical properties.

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

• Not Applicable. Not a clinical study requiring adjudication of expert readings.

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. This is not an AI-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable / Pre-defined standards. For the non-clinical tests:
  • Sterilization: Ground truth is defined by the requirements of ISO 17665-1 and 17665-2.
  • Biocompatibility: Ground truth is defined by the requirements of ISO 10993-5 and 10993-12.
  • Mechanical Testing: Ground truth is defined by the requirements of ISO 14801 for dynamic loading, and internal company specifications for retention force (compared to the predicate).
  • MRI Review: Ground truth is based on scientific rationale and published literature for material properties in an MR environment.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set."

In summary, the provided FDA 510(k) clearance letter and summary are for a traditional Class II dental device (an attachment system for dental implants), not an AI/ML medical device. Therefore, the questions related to AI/ML specific study design elements (test sets, ground truth by experts, MRMC studies, training sets) are not applicable to the content of this document.

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