Search Results

Intended for use in reconstruction of natural or surgical periodontal defects of the oral and maxillofacial region, including sinus floor elevation and augmentation of the alveolar crest.

Intended for filling into the site of a bony defect in combination with patient blood, autologous bone, membranes or sterile saline after removal of cysts or surgical removal of retained teeth.

ArrowBone-B consists of high purity Tricalcium Phosphate Ceramics of which the Ca/P ratio is 1.50. It is manufactured by a validated manufacturing process which guarantees pure-phase materials depending on the sintering temperature. This process is illustrated in Appendix I. Basically, it involves the well-established methods of wet synthesis from phosphoric acid and calcium hydroxide in dilute solution, spray drying to make spherical aggregates, calcination of the aggregates, x-ray diffraction analysis/identification of impurities, removal of fines by sieving, and molding of the particles into porous granules. These are then sintered at the selected temperature for the product which incinerates and removes the binder, hydroxypropyl cellulose, for which the specifications are shown in Appendix 1.6.

The chemical composition of this material is shown. It can be identified by x-ray powder diffraction analysis as pure-phase beta-Tricalcium Phosphate Ceramic in ArrowBone-B. The diffraction analysis is provided.. The identifying peaks as shown on these patterns for ßtricalcium phosphate are indicated by open circles. These data show that the crystalline structure of ArrowBone-B is pure-phase beta-Tricalcium Phosphate

No acceptance criteria or study demonstrating that the device meets acceptance criteria are described in the provided text. The document is a 510(k) summary for ArrowBone-B, focusing on substantial equivalence to predicate devices, and details about its composition, manufacturing, and general compliance with performance standards and regulations.

The document does mention an "extensive animal implantation study of ArrowBone-B was recently conducted by independent scientists at the Tokyo Medical and Dental University" (Section VIII, not fully provided, but mentioned in Section VII. Substantial Equivalence). This study observed "biocompatibility and biodegradation of TCP, which was absorbed by new bone." However, this is presented as evidence for substantial equivalence and biocompatibility, not as a study proving specific performance criteria against a set of defined acceptance criteria for device function in humans.

Therefore, I cannot provide the requested table or information because the input text does not contain acceptance criteria for device performance nor a study designed to prove the device meets such criteria.

Ask a specific question about this device

Cleaning, polishing and restoring natural esthetics of tooth enamel.

The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm

The provided text is a 510(k) summary for a medical device (B-Powder) and a clearance letter from the FDA. This type of documentation focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not present in the provided text.

Here's why and what can be extracted:

• No Acceptance Criteria or Performance Reporting: The 510(k) process for this device (B-Powder) establishes that it is "substantially equivalent" to already marketed devices. This means the manufacturer did not have to conduct new clinical trials to prove efficacy or safety against specific performance metrics, but rather demonstrate that its characteristics and intended use are similar enough to existing, cleared devices.
• Focus on Material Composition and Intended Use: The summary focuses on the material composition (beta-tricalcium phosphate with some hydroxyapatite) and its intended use (polishing/prophy powder) being similar to predicate devices.
• Analytical Testing, Not Clinical Studies: The "studies" mentioned (X-ray diffraction, ICP/MS, atomic absorption spectrophotometry) are analytical tests to characterize the material, not clinical performance studies. These tests confirm the material content and the absence of harmful elements, but they don't assess clinical outcomes like cleaning effectiveness or polishing quality in a human population.
• MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are typically relevant for AI-powered diagnostic or prognostic devices that perform classifications or measurements. The B-Powder is a physical dental material, so these types of studies are not applicable.

In summary, based only on the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, expert ground truth, or AI study specifics because this information is not part of a 510(k) submission for this type of device.

The document states: "Compliance with Performance Standards: No performance standards are applicable." This directly indicates that there aren't formal quantitative acceptance criteria for this device that would be proven by a performance study.

Here's what I can extract and explain based on the provided text, addressing the spirit of your request where possible by highlighting what was not done or not required for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported as part of this 510(k) submission. The evaluation was based on material characterization and comparison to predicate devices, not clinical performance testing.

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. No ground truth establishment by experts for a test set was required or mentioned for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used or mentioned.

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 device is a dental polishing powder, not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental polishing powder, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for clearance was "substantial equivalence" to legally marketed predicate devices, not performance against an independently established clinical ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set
Not applicable. There was no "training set" for this device, as it is a material and not an algorithm.

9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in the context of an algorithm's development was relevant or established for this submission.

Ask a specific question about this device

Mytis Arrow XXXX systems are intended for immediate placement in extraction or surgically prepared sites in partially or fully edentulous mandibles and maxillae (type 1 or II bone), in support of single or multiple-unit restorations including; cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Mytis Arrow Implant system comprises various sets of root form endosseous dental implants and compatible implant abutment systems. Mytis Arrow Systems are designed for use in dental implant surgery and are intended to be used in a manor in which the implant integrates with the bone. The Mytis Arrow abutments include various abutments designed to enable the implant process from healing through final restoration. Mytis implants are for single and two-stage surgical procedures.

I am sorry, but the provided text describes a 510(k) premarket notification for a dental implant system (Mytis Arrow Implant Systems). This document focuses on demonstrating substantial equivalence to predicate devices and outlines the intended use and classification of the device.

There is no information within the provided text about:

1. Acceptance criteria for device performance.
2. Study data proving the device meets performance criteria.
3. Sample size for test sets.
4. Data provenance.
5. Number of experts or their qualifications.
6. Adjudication method.
7. MRMC comparative effectiveness studies.
8. Standalone (algorithm only) performance.
9. Type of ground truth used.
10. Sample size for training set.
11. How ground truth for the training set was established.

Therefore, I cannot provide the information requested in your prompt based on the provided document. The document is a regulatory submission for premarket clearance, not a clinical study report.

Ask a specific question about this device