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The REST EAZY Appliance is intended for use in adult patients for the reduction of snoring and mild to moderate obstructive sleep apnea. The REST EAZY Appliance is worn while sleeping to support the lower jaw in a forward position as prescribed by the dentist. The appliance is removable by the patient.

The proposed REST EAZY Appliance device consists of an upper and lower acrylic splint, custom fabricated to the patient's teeth. The splints are connected to each other via the REST EAZY adjustable Herbst style mechanism that orients the jaw in a predetermined relationship. These devices function as a mandibular repositioner, which increases the pharyngeal space. An enlarged pharyngeal space assists the patient with improved air exchange. The device is custom fit for each patient, as prescribed by the dentist.

The provided text is a 510(k) Summary for the REST EAZY Appliance. It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as would be found for complex AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and clinical study details (like sample size for test sets, expert qualifications, and adjudication methods) is not applicable or not available in this specific document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific quantitative acceptance criteria or performance metrics in a table format for the device's efficacy in reducing snoring or treating obstructive sleep apnea. Instead, it relies on demonstrating substantial equivalence to an already cleared predicate device (Specialty Appliance Works, Inc.'s Acrylic Splint Herbst Appliance).

The reported "performance" is implicitly tied to this substantial equivalence; the new device is expected to perform similarly to the predicate.

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

• Not applicable. This submission is based on demonstrating substantial equivalence through comparison of technological characteristics and materials to a predicate device, not through a new clinical performance study. The data provenance mentioned refers to the biocompatibility and physical properties of the materials, which were established through prior testing of a cleared component (Variflex K033632).

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

• Not applicable. No new clinical "test set" requiring expert ground truth establishment for diagnostic performance is described in this document.

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

• Not applicable. As no clinical test set requiring expert adjudication for ground truth is described.

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. The device is a physical intraoral appliance.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable. For this type of 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the FDA's prior clearance of the predicate device based on its established safety and effectiveness. The performance of the new device is inferred to be similar due to its substantially equivalent characteristics.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device that requires a training set.

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

• Not applicable. This is not a machine learning device.

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The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.

The M-CORE disposable core biopsy needle is a sterile, disposable biopsy needle featuring stainless steel cutting cannula and stylet, with sample is a lotenio, disposable biopsy needle leading stames steaturing statiness steat themoplastic removable spacer is provided to allow easy insection of both hubs into a Bard@ Magnum® reusable biopsy instrument. An LDP of the county the neder in both huss in a Barde Magnum® reuseble available in gauges from 14 - 18 and lengths from 10 - 25 centimeters.

The provided 510(k) summary for the M-CORE disposable core biopsy needle does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. The document focuses on demonstrating substantial equivalence to predicate devices based on design and materials, and mentions "Performance testing summary" but does not elaborate on the specific tests or their results within this summary.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., biopsy sample quality scores, tensile strength, or cutting efficiency thresholds). Instead, it relies on demonstrating that the device is "substantially equivalent" to predicate devices, implying similar performance.

The summary states: "Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivalent to the predicate device(s)." This is a general statement of performance, not a quantified measurement against an acceptance criterion.

The table provided in the document compares device characteristics, not performance metrics:

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

The 510(k) summary does not provide any information regarding the sample size used for performance testing (e.g., number of biopsies performed, number of needles tested). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

No information is provided about experts used to establish ground truth. The summary mentions "the quality of the samples obtained," suggesting an evaluation of biopsy specimens, but does not detail how this quality was assessed or by whom.

4. Adjudication Method for the Test Set

No information is provided regarding any adjudication method for performance testing.

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

No MRMC study is mentioned or implied. This device is a biopsy needle, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

While not explicitly called "ground truth," the performance testing likely involved assessing the "quality of samples obtained." This would typically be evaluated through:
* Histopathology/Pathology: Examination of the tissue samples by a pathologist to determine adequacy for diagnosis.
* Visual Inspection/Gross Examination: Assessment of the sample size, integrity, and appearance.
The document does not specify which of these, or any other method, was used.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

In summary, the provided 510(k) notification primarily focuses on demonstrating substantial equivalence through a comparison of design and materials with predicate devices, and a general statement about performance testing confirming sample quality. It lacks the specific details about acceptance criteria, study sizes, methodologies, and expert involvement that your detailed questions request. This level of detail is often found in the full test reports referenced (e.g., "See Section 18" for Performance Testing Summary), but not typically within the concise 510(k) summary itself.

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