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The Levo System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

The Levo System is designed to assist the qualified health care professional in evaluating the patient's tinnitus and preparing a customized sound therapy to be delivered to the patient during treatment. The Levo System provides idiopathic tinnitus masking treatment based upon sound stimulation during sleeping or waking hours. The Levo System consists of two proprietary software applications that are pre-installed on commercially available, off-the shelf consumer electronics (i.e., Apple® iPad® or iPad Air™ and iPod®. Custom-fit ear buds are provided with the device. The Levo System uses amplitude modulated tinnitus pitch matched tones, narrow-band noise centered at the tinnitus frequency, and broad-band noise.

The provided text describes a 510(k) submission for the Otoharmonics® Levo® System, a tinnitus masker device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for clinical efficacy.

Therefore, many of the requested details about acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided because the regulatory pathway for this device, at this stage, relies on demonstrating comparable technical and safety characteristics to a legally marketed predicate device.

Here's an attempt to extract and infer information based on the provided text, addressing each point as much as possible:

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

The document does not present a table of specific clinical acceptance criteria for relief of tinnitus symptoms or quantifiable performance metrics in that regard. Instead, it focuses on demonstrating that the Levo System meets safety and technical performance requirements comparable to its predicate device.

• Frequency response of ear buds, patient device, and software
• Amplitude of generated output
• Software/firmware performance
• Amplitude modulation of signal
• Independent volume control of left and right channel. |
  | General Functionality (Substantial Equivalence): | |
  | Intended Use/Indications for Use (Same as predicate) | Same intended uses and similar indications as the predicate. |
  | Technological Characteristics (Similar to predicate) | Very similar technological characteristics in device design and specifications. Generates same general types of sounds and amplitude modulated tones. |
  | Principles of Operation (Similar to predicate) | Similar principles of operation as the predicate device. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes nonclinical testing for validation and verification, primarily focusing on engineering and software performance. It does not mention a "test set" in the context of patient data, clinical trials, or clinical endpoints for the device's efficacy in relieving tinnitus symptoms. Therefore, information about sample size, data provenance, and study type (retrospective/prospective) for a clinical test set is not provided.

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. The document does not describe a clinical test set requiring expert-established ground truth for performance evaluation of tinnitus relief. The "ground truth" here is primarily against pre-defined engineering specifications and regulatory standards.

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

Not applicable, as no clinical test set for performance evaluation 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 device is a tinnitus masker, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" interpreting data. An MRMC study is not relevant to the described device and its regulatory submission.

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

The primary performance studies described are standalone technical and software verification/validation tests. These confirm that:

• The software performs as intended and in accordance with specifications.
• The acoustic outputs meet specifications (frequency response, amplitude, modulation, volume control).
• Biocompatibility, electrical safety, and electromagnetic compatibility standards are met.

The device itself is designed to be used with the advice of a physician, audiologist or other hearing healthcare professional, who prepares the customized sound therapy. So, while the underlying technical components are tested in a standalone manner, the overall system functions as a tool within a human-guided tinnitus management program.

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

For the nonclinical performance testing, the "ground truth" used are:

• Engineering specifications: For frequency response, amplitude, software/firmware performance, etc.
• Regulatory standards: Such as ISO 10993 for biocompatibility, AAMI/ANSI ES 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility.
• Predicate device characteristics: To demonstrate substantial equivalence in intended use, technological characteristics, and principles of operation.

No clinical outcomes data or expert consensus on patient response to treatment is detailed in this 510(k) summary, as it falls under demonstrating substantial equivalence, not clinical efficacy through new trials.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or AI models that would require a "training set" in the conventional sense. The software's functionality is based on pre-defined algorithms for generating sound therapies, not learning from data.

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

Not applicable, as no training set for an AI/ML model is mentioned.

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