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• 1. Bonding of light cured composites and acid modified composites (compomers) to tooth structure.
• Bonding of dual cured luting and core build up composites to tooth structure as long as these materials 2. are light cured.
• 3. Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing.
• Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, 4. CAD/CAM hybrid resin crowns and composites.
• 5. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
• Treatment of hypersensitive teeth. 6.

G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquid bottle or unit dose.

Here's an analysis of the provided text regarding the acceptance criteria and study for the G-Premio BOND device, organized according to your requested points:

Note: The provided document is a 510(k) premarket notification summary. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a device's standalone performance or clinical trials as might be found in a full scientific publication. Therefore, some of your requested information, particularly regarding "study" details like sample sizes for training sets, adjudication methods, or MRMC studies, is not present in this regulatory submission. The "study" described here is primarily a bench test to show compliance with internal specifications and substantial equivalence, not a clinical trial.

Acceptance Criteria and Reported Device Performance

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

10 MPa for dentin | Equivalent to predicate bond strengths in enamel and dentin bonding. Results met the >10MPa requirement. |
| 4. Bond strength to metal | > 10 MPa for precious metal
10 MPa for non-precious metal | > 10 MPa (implied by "equivalent to the predicate bond strengths") |
| 5. Bond strength to ceramic and composite | > 10 MPa for porcelain
10 MPa for composite
10 MPa for zirconia | > 10 MPa (implied by "equivalent to the predicate bond strengths") |
| 6. Application characteristics | Should be formed even and homogenous coat. | Conforms (implied by "conforms to the required specifications") |
| 7. Sealing property of dentin tubules | Should be sealed dentin tubules when observed using SEM | Dentin tubules were sealed (supported by SEM images) |

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

• Sample Size for Test Set: Not explicitly stated in the document for the bench tests.
• Data Provenance: The document implies that the testing was conducted by GC America Inc. or its parent company (GC Corporation), likely in a laboratory setting. There is no information regarding the country of origin of data or if it was retrospective or prospective in a clinical sense. These are bench test results, not clinical data.

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 in the document. The acceptance criteria were established by the company (GC America Inc. specification AB-15-Q-301-631(1)), and the performance was measured against these internal specifications and compared to a predicate device. There is no indication of external experts establishing a "ground truth" for the test set in the conventional sense of a clinical study.

4. Adjudication method for the test set

• This information is not applicable/not provided for these types of bench tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of results (e.g., imaging) by multiple readers, which is not the nature of the performance tests described here (e.g., bond strength, curing properties, appearance).

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 dental bonding agent, a physical product, not an AI-powered diagnostic or assistive tool. Therefore, this question is not applicable to the device described.

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

• No, this question is not applicable. The device is a dental bonding agent, and there is no algorithm involved. The performance tests are for the physical properties of the bonding agent itself.

7. The type of ground truth used

• For physical properties like bond strength, curing, appearance, pH, etc., the "ground truth" is defined by established scientific and engineering measurement standards and internal company specifications. For the sealing property of dentin tubules, the "ground truth" was visual confirmation via Scanning Electron Microscopy (SEM) images (implied to be assessed as "sealed").
• For the purpose of the 510(k) submission, the ultimate "ground truth" for demonstrating substantial equivalence was showing that the device performed similarly to or better than the predicate device across key technical characteristics, and met its own predefined specifications.

8. The sample size for the training set

• This information is not applicable/not provided. There is no "training set" in the context of this device, as it is a physical product and not a machine learning model.

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

• This information is not applicable/not provided. As above, there is no "training set" for this type of device.

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The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "PREMIO 10 moxa," which is an infrared lamp. This type of document typically confirms that a device has been cleared for market based on substantial equivalence to a predicate device, but it does not include detailed information about the acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a detailed premarket submission.

Specifically, the document does not provide any information on:

1. Acceptance criteria or reported device performance
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth used for a test set.
3. Sample size or ground truth establishment for a training set.

The letter focuses on regulatory compliance and substantial equivalence, not on the results of a performance study with detailed acceptance criteria and study methodologies.

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PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.

PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.

The provided text describes the submission of a 510(k) premarket notification for a new surgical suture device named PREMIO®. The purpose of this submission is to demonstrate that PREMIO® is substantially equivalent to a legally marketed predicate device, PRONOVA™. The document focuses on comparing the new device to the predicate device, particularly regarding their technological characteristics and intended use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that non-clinical laboratory testing was performed. However, it does not specify the sample size used for this testing. The data provenance is also not detailed beyond mentioning "non-clinical laboratory testing." It does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on laboratory testing against established pharmacopoeia standards (USP and EP) rather than expert review of cases or outcomes.

4. Adjudication Method for the Test Set

Since there is no mention of experts or a test set requiring adjudication in the context of human review, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. The submission focuses on demonstrating substantial equivalence through technological and performance comparisons against established standards and a predicate device, not on assessing human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the device being described. PREMIO® is a physical surgical suture, not a software algorithm or AI-powered system designed for standalone performance or human-in-the-loop assistance.

7. Type of Ground Truth Used

The ground truth used for evaluating PREMIO® appears to be the established standards and specifications outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. The biocompatibility of the raw material is also cited as "proven," likely referring to existing literature or prior regulatory approvals for the material.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. PREMIO® is a physical medical device, not a machine learning model that requires a training set. The evaluation is based on laboratory testing and comparison to a predicate device and monograph standards.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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