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To amplify and transmit sound to the ear.

Both the 48 and the 49PP are small slim-lined body aids. Their unique shape fits snugly and inconspicuously into any pocket or other places,e.g. brasiere etc. The 48 and the 49PP both have audio input that allows the connection to external sources. Also both have 3 position switch for off-telecoil-microphone. Assembled from standard components which are widely utilized by other hearing aid manufacturers.

Here's the analysis of the provided information regarding Rexton's Model 48 and 49PP in the context of the requested acceptance criteria and study details.

Based on the provided K970537 document, the information available is extremely limited and does not contain any of the requested details regarding acceptance criteria or a study proving device performance in the modern sense of medical device evaluation (e.g., clinical trials, AI performance studies).

The document describes a simple hearing aid submission from 1997. The concept of "acceptance criteria" and "device performance" in this context refers to technical specifications and equivalence to predicate devices, not to metrics like sensitivity, specificity, or reader improvement with AI. Similarly, a "study" here refers to the demonstration of compliance with existing standards (S3.22-1987 ANSI Specifications) rather than a clinical investigation or an AI performance study with a test set, ground truth, or experts.

Therefore, many of the requested fields cannot be populated from the provided text.

Analysis of K970537 for Rexton's Model 48 and 49PP

1. Table of Acceptance Criteria and Reported Device Performance

• Adherence to relevant industry standards. | Technical specifications comply with S3.22-1987 ANSI Specifications. Preliminary data sheets for the 48 and 49PP are enclosed (details not provided in summary). |
  | Substantial Equivalence:
• Device features and intended use are similar to existing approved devices. | "Substantially equivalent to other body aids." |
  | Intended Use:
• Device effectively amplifies and transmits sound to the ear. | "To amplify and transmit sound to the ear." (Functional claim, no performance metrics provided). |
  | Component Standardization:
• Constructed from widely utilized, standard components. | "Assembled from standard components which are widely utilized by other hearing aid manufacturers." |
  | Physical Characteristics:
• Small, slim-lined, fits snugly and inconspicuously. | "Both the 48 and the 49PP are small slim-lined body aids. Their unique shape fits snugly and inconspicuously into any pocket or other places, e.g. brasiere etc." |
  | Input/Switch Functionality:
• Audio input and 3-position switch for off-telecoil-microphone. | "Both the 48 and the 49PP both have audio input that allows the connection to external sources. Also both have 3 position switch for off-telecoil-microphone." |
  | Power Source:
• Compatible with standard battery. | "Standard battery size AA." |
  | User Manual/Information:
• Supplied with each hearing aid. | "A user's manual and other information is supplied with each hearing aid (enclosed)." |

Note: The "reported device performance" here is largely descriptive and refers to compliance with specifications and equivalence, not to quantifiable, clinical performance metrics. This is typical for a 510(k) submission based on substantial equivalence to a predicate device from this era, especially for a non-AI device.

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

Not applicable. The provided document does not describe any test set for evaluating a device's performance in a clinical or AI context. The "study" mentioned refers to compliance with ANSI standards, not a clinical trial or performance evaluation using a test set of patient data.

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

Not applicable. There is no mention of a test set, ground truth, or experts in the provided document.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set or adjudication.

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 hearing aid submitted in 1997 and does not involve AI or human readers for diagnostic interpretation. An MRMC study is completely irrelevant here.

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

Not applicable. This device is a hearing aid submitted in 1997 and does not involve an algorithm or AI.

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

Not applicable. There is no mention of ground truth in the context of performance metrics for this device. The "ground truth" for this approval would be the established ANSI standards and the characteristics of the predicate devices for achieving substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a hearing aid submitted in 1997 and does not involve machine learning or training sets.

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

Not applicable. This device is a hearing aid submitted in 1997 and does not involve machine learning or training sets.

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To amplify and transmit sound to the ear.

The Piccolo series of BTE's are a small compact hearing aid. It has incorporated in it's package a very slim housing that can be worn with glasses. The use of the new modern and small receiver enables the integrated amplifier to have better battery life with less distortion.The aid also has AGC-I, active low frequency tone control and a three position, rotating switch for Off-Telecoil-Microphone.

This document describes a hearing aid device, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from the provided text.

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To amplify and transmit sound to the ear.

The Rexton Long Life Rx-12 is a full shell hearing aid utilizing a 675 battery and a low drain class D circuit. The combination of these to unique features gives the Rexton Long Life the ease of battery handling (a large 675 battery) and the benifits of extended battery life. These two features should make for a special product with-in the industry. Assembled from standard components which are widely utilized by other hearing aid manufacturers.

This document describes a hearing aid device and focuses on its features and technical characteristics rather than providing details on a study proving its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted.

However, based on the provided text, we can infer some information:

1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or present reported device performance against such criteria. It highlights features and technical characteristics.

Missing Information: Quantitative acceptance criteria (e.g., specific battery life duration, sound amplification levels, distortion limits) and numerical performance data are not provided in the text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document describes the device's features and technical characteristics, but no details about a test set or its provenance are mentioned.

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)
This information is not available in the provided text. The document does not describe any study involving experts to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No details about a test set or its adjudication are mentioned.

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
This information is not available in the provided text. The device is a hearing aid, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely to be relevant to this specific product description.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a hearing aid, which by its nature is a human-in-the-loop device. No standalone algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided text. No ground truth is discussed as there is no description of a study for verifying performance against a criterion.

8. The sample size for the training set
This information is not available in the provided text. The document does not describe any training or machine learning component.

9. How the ground truth for the training set was established
This information is not available in the provided text. No ground truth or training set is mentioned.

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Ask a specific question about this device