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Wizard Loudness Growth Tester
The provided text is a 510(k) summary for the "Wizard Loudness Growth Tester" and contains very limited information regarding acceptance criteria and study details. It primarily focuses on demonstrating substantial equivalence to existing devices.
Therefore, most of the requested information cannot be extracted from this document. However, I can still structure the answer to highlight what is available and what is missing.
Unable to Extract Most Requested Information:
The provided 510(k) summary is extremely brief and lacks the detailed performance study information typically found in a comprehensive submission. It focuses on declaring substantial equivalence and adherence to a standard, rather than presenting a detailed study with acceptance criteria and results.
Here's an attempt to answer based on the very limited information provided:
Acceptance Criteria and Study for Wizard Loudness Growth Tester
Based on the provided 510(k) summary (196201), the information regarding specific acceptance criteria, detailed study design, and performance metrics is extremely limited. The submission primarily relies on demonstrating substantial equivalence to existing devices and adherence to an industry standard.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Meets requirements specified by ANSI S3.6-1989 (Specification for Audiometers) | "Performance of this instrument meets requirements specified by ANSI S3.6-1989." |
| Follows traditional principles of operation for Loudness Growth Testers | "The design follows traditional principles of operation for Loudness Growth Testers." |
| Manufactured and assembled with equivalent manufacturing practices | "The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines." |
| User controls and methods similar to others currently marketed | "User controls and methods are similar to others currently being marketed." |
| Demonstrates substantial equivalence as required by SMDA 1990 | "The summary of information, new product to present products demonstrates substantial equivalence as required by the 'Safe Medical Devices Act (SMDA)' of 1990." |
Missing Information:
- No specific, quantifiable acceptance criteria (e.g., accuracy, precision, sensitivity, specificity, noise levels) are provided beyond the general statement of meeting the ANSI standard.
- No numerical performance data points (e.g., measured accuracy, specific test results) are reported.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information:
- The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective).
- It does not describe any clinical or technical study conducted with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Missing Information:
- As no specific test set or study is described, there is no information on experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
Missing Information:
- No adjudication method is mentioned as no specific test set or study is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Missing Information:
- No MRMC study is mentioned. This device (a Loudness Growth Tester) is an audiological diagnostic instrument, and MRMC studies are more common for imaging interpretation by human readers. The concept of "human readers improve with AI vs without AI assistance" does not directly apply to this type of device in the way it would for AI-assisted image analysis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information:
- The document does not describe any algorithm in the sense of AI or automated decision-making that would require standalone performance evaluation. The device appears to be a traditional diagnostic instrument, not an AI-driven tool.
7. The Type of Ground Truth Used
Missing Information:
- No ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned as no specific performance study is detailed. The "ground truth" would likely be the accurate measurement of loudness growth, validated against established audiological principles, but the specific validation method is not described.
8. The Sample Size for the Training Set
Missing Information:
- No training set is mentioned. This device does not appear to be an AI/machine learning device that would typically involve a training set.
9. How the Ground Truth for the Training Set was Established
Missing Information:
- No training set or associated ground truth establishment is mentioned.
Conclusion:
The provided 510(k) summary for the Wizard Loudness Growth Tester is a "summary" in the truest sense, offering minimal detail on performance evaluation beyond a general declaration of meeting ANSI S3.6-1989 and being substantially equivalent to predicate devices. For a more comprehensive understanding of the device's specific acceptance criteria and the studies proving it, one would need to review the full 510(k) submission, if available.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.