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Additive production of temporary anterior and posterior restorations, e.g.

• Single tooth crowns.
• Bridges (max. six units, max. two consecutive pontics).
• Veneers, Inlays, Onlays.

P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.
It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products.
Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.

The provided text is a 510(k) Summary for a dental device called "P pro Crown & Bridge." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on the chemical, physical, and biocompatibility properties of the material rather than a "device" in the sense of an AI or diagnostic tool that would typically involve a multi-reader, multi-case study or extensive clinical performance data with ground truth experts.

Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC, human reader improvement, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning its physical, mechanical, and biocompatibility properties.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for "P pro Crown & Bridge" are primarily based on established ISO standards for dental materials (ISO 4049 and ISO 10477) and an internal DeltaMed standard for compressive strength. The device performance is then compared directly against these criteria and its predicate devices.

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

Biocompatibility (ISO 10993-1, -5, -10):

Study Details (as inferable from the document):

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

• Sample size: Not explicitly stated in terms of the number of individual specimens tested for each property (e.g., how many samples for flexural strength). However, the results (e.g., "146 MPa") imply a quantitative measurement from a test set.
• Data provenance:
  • Country of origin: The manufacturer, DeltaMed GmbH, is based in Friedberg, Germany. The testing would presumably be conducted in Germany or by certified labs adhering to international standards.
  • Retrospective or Prospective: These are laboratory tests on material samples, not clinical studies involving patient data. Therefore, "retrospective" or "prospective" as typically applied to clinical data collection does not directly apply. The tests are conducted on manufactured material samples to demonstrate performance against specifications.

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

• Not Applicable. For a material device, "ground truth" is established by adherence to physical, chemical, and biological testing standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). The "truth" is the measured property value compared to the standard's requirement, not an expert's interpretation of an image or clinical finding. These tests are performed by qualified laboratory technicians/scientists following validated protocols.

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

• Not Applicable. Adjudication methods are relevant for subjective assessments (e.g., consensus among radiologists). For objective material properties testing, results are quantitative and directly measured. Statistical analysis of multiple measurements would be performed to ensure reliability, but not "adjudication."

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 a material device, not a diagnostic imaging device or AI software. There are no "human readers" or "AI assistance" in this context.

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

• Not Applicable. This is a material device.

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

• Objective Laboratory Measurements against International Standards: The "ground truth" is derived from standardized laboratory testing procedures (e.g., measuring flexural strength, water absorption, cytotoxicity) as defined by ISO standards (ISO 4049, ISO 10477, ISO 10993). The "truth" is whether the measured physical/chemical property falls within the acceptable range specified by these standards.

8. The sample size for the training set:

• Not Applicable. This device is a material, not an AI/machine learning algorithm that requires a "training set." The characteristics of the material are inherent to its composition and manufacturing process, not learned from data. Extensive R&D and formulation development would have occurred, but not in the sense of "training data."

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

• Not Applicable. No "training set" as defined for AI/ML. The properties of the material (composition, etc.) are determined during the material science and engineering development process.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The P & F POWERED WHEELCHAIR, HC-500SB is an indoor / outdoor wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

Here is the information about the acceptance criteria and study for the P & F POWERED WHEELCHAIR, HC-500SB:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a distinct "test set" in terms of patient data or a specific number of devices tested for each individual criterion. The testing appears to have been conducted on a single prototype or representative unit of the P & F POWERED WHEELCHAIR, HC-500SB.
• Data Provenance: Not applicable in the context of patient data for a diagnostic/AI device. The testing was conducted by the manufacturer (P & F BROTHER IND., CORP.) and potentially third-party labs (e.g., SGS for upholstery, UL for electronics) on the device itself, not on patient data. This is product performance testing, not clinical data testing.

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

• Not applicable. This is not an AI or diagnostic device that relies on expert interpretation of data to establish a ground truth for a test set. The "ground truth" here is compliance with established engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable. There was no "test set" of patient data requiring adjudication. Compliance with engineering standards and comparison to a predicate device were the primary methods.

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, an MRMC comparative effectiveness study was not done. This device is a powered wheelchair, not an AI or diagnostic tool.

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

• No, this is not an algorithm-based device. Performance testing focused on the physical and electrical safety and functionality of the wheelchair itself.

7. The type of ground truth used:

• The "ground truth" for this submission is based on:
  • Compliance with established international and national standards: Specifically, EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, and UL certification for electrical components.
  • Substantial Equivalence to a legally marketed predicate device: The P & F POWER WHEELCHAIR, HC-510 (K070350). The performance characteristics of the predicate device serve as the benchmark for many of the "acceptance criteria."

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. There was no training set.

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The indications for use of pReference Treatment Planning Software 1.1 are such intracranial diseases as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Not Found

This is a 510(k) clearance letter and an Indications for Use statement for the "pReference Treatment Planning Software 1.1". These documents confirm the device's clearance for marketing based on substantial equivalence to a predicate device, but they do not contain information about acceptance criteria or specific study details proving the device meets those criteria, nor do they include performance metrics like those typically found in a clinical study report.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a clinical study report, a validation report, or a similar performance evaluation document for the pReference Treatment Planning Software 1.1.

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