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The EasyRA Creatine Kinase-MB (CK-MB) Reagent is intended for the quantitative determination of CK-MB activity in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements of CK-MB activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only. For prescription use only.

Medica's EasyRA C-Reactive Protein (CRP) Reagent is intended for use in the quantitative in-vitro diagnostic determination of C-reactive protein in human serum or plasma using the EasyRA clinical chemistry analyzer. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in-vitro diagnostic use only. For prescription use only.

The EasyCAL C-Reactive Protein (CRP) Calibrator Kit is used for calibrating the CRP assay on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA CRP Reagent. The CRP calibrators are used to establish points of reference that are used in the determination of values in the measurement of CRP in human serum and plasma. For in-vitro diagnostic use only. For prescription use only.

The EasyQC C-Reactive Protein (CRP) Quality Control Materials are intended for use as quality control material for the CRP turbidimetric assay, using the EasyRA CRP Reagent and calibrator kit on the EasyRA clinical chemistry analyzer. For in-vitro diagnostic use only. For prescription use only.

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This document is a letter from the FDA regarding the 510(k) premarket notification for several diagnostic reagents and related calibrator/control materials. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not performance studies.

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The Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate.

This document describes a Special 510(k) notice for "Grind No More Generation II," a mouthguard designed to protect against bruxism. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing detailed acceptance criteria through performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found or required for a Special 510(k) submission for a device like a mouthguard, which primarily relies on technological similarity and established safety/effectiveness of predicate devices.

Here's a breakdown of why specific information is missing and what can be inferred from the provided text:

Missing Information and Reasons:

• 1. A table of acceptance criteria and the reported device performance: Not provided. For a Special 510(k) based on substantial equivalence, specific performance acceptance criteria and new performance data (beyond demonstrating technological similarity) are generally not required if the changes are minor and do not raise new questions of safety or effectiveness. The device's performance is assumed to be similar to its predicate devices.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No new performance study (test set) was conducted to support this Special 510(k). The submission relies on the established safety and effectiveness of the predicate devices.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth assessment by experts for a test set is typically for performance validation studies, which were not performed in this case.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 medical device (mouthguard), not an AI-powered diagnostic or assistive tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed performance studies were not conducted for this device's submission. The "ground truth" for showing substantial equivalence relies on the regulatory approval and safety/effectiveness history of the predicate devices.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information Available from the Document:

While the requested specifics are not present, we can understand the basis of the submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence):

• Acceptance Criteria for Special 510(k): The primary acceptance criterion for a Special 510(k) in this context is demonstrating that the modified device (Grind No More Generation II) is substantially equivalent to its predicate devices (Grind No More 2 and Rest Assured Nite Protector).
• Demonstration of Substantial Equivalence: This is achieved by showing that the new device has:
  • The same intended uses (protection against bruxism/nighttime teeth grinding, reducing damage to teeth, preventing noise).
  • Similar indications.
  • Similar technological characteristics and principles of operation.
  • Minor technological differences that raise no new questions of safety or effectiveness.

Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the comparison to predicate devices and the argument for substantial equivalence, as presented in the Special 510(k) notice.

• Device Performance (as reported):
  • "Grind No More Generation II is as safe and effective as the predicate devices."
  • It "has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices."
  • The "minor technological differences... raise no new questions of safety or effectiveness."

Predicate Devices:

• Ranir, LLC's Grind No More 2 (K091175)
• Ranir, LLC's Rest Assured Nite Protector (K063229)

Technological Characteristics of the Grind No More Generation II:

• Anterior and posterior occlusive mouthguard.
• Consists of two molar bite plates and an anterior bite plate connected by a buccal retention band.
• Molar bite plates are grooved with vertical positioners for enhanced retention (similar to Grind No More 2).
• Addition of an anterior bite plate (the primary modification from Grind No More 2, but technologically similar to the predicate Rest Assured).

In summary, for this specific Special 510(k) submission, the "acceptance criteria" and "study" are less about novel performance data and more about demonstrating that the minor modifications to an already approved device do not alter its fundamental safety and effectiveness compared to its predicates.

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