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The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource II fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals.

ReSound's Digital 5000 series hearing devices are built using a custom software programmable digital signal processor. The DSP includes two analog to digital converters (ADC) at the input stage and one digital to analog converter (DAC) at the output stage. Using a personal computer (PC) connected to the hearing device via standard CS45 cable, numerous signal processing and amplification parameters may be adjusted to help compensate for impaired hearing. In addition, proprietary software used only by hearing health care professionals can instruct the output DAC to produce specific sounds. These sound stimuli, when delivered at different amplitudes and frequencies, can be used for loudness scaling measurements helpful in fitting the hearing device more precisely to the patient's residual hearing dynamic range.

The LGOB test equipment is comprised of proprietary PC software and a ReSound Digital 5000 series hearing device. Similar to the Loudness Growth in Octave Bands (LGOB) test provided with the original ReSound® P3 System, this new hearing device fitting method is designed to subjectively measure loudness growth in hearingimpaired subjects using the subject's own hearing aid, instead of using insert phones. The test is to be performed only by qualified hearing healthcare professionals. When the hearing aids are disconnected from the fitting computer, they function normally.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ReSound LGOB Test using Digital Hearing Devices:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Premarket Notification, focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance metrics for the new device. Therefore, a table in the traditional sense, with quantitative acceptance criteria and reported values, cannot be fully constructed from this document.

However, based on the principle of substantial equivalence, the implicit acceptance criteria are that the new device performs at least as well as and is as safe and effective as the predicate device for its intended use. The performance characteristics described are qualitative comparisons to the predicate.

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

The document does not provide information on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The filing is based on demonstrating substantial equivalence through comparison of design, intended use, and technical principles, rather than presenting a new clinical trial for performance validation. The comparison is conceptual, referring to the functionality and method of the predicate device (ReSound Portable Prescriptive Programming (P3) System, K912669).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

No explicit "ground truth" establishment by experts for a specific test set is described. The validity of the LGOB method itself is referenced through a published scientific paper: "J. B. Allen. J. L. Hall, and P. S. Jeng. 'Loudness growth in 1/2-octave bands (LGOB) - A procedure for the assessment of loudness', Journal of the Acoustical Society of America - 1988 (2), 1990, pp. 745-753." This publication describes the scientific basis for the LGOB procedure, which is the foundation of both the predicate and the new device.

The document states the device is intended to be used by "qualified hearing healthcare professionals," implying that the interpretation and application of the results would be done by these experts.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set requiring adjudication is described in the document.

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. The device described is not an AI-assisted diagnostic tool in the sense of image interpretation for human readers. It's an audiometric diagnostic device where the patient provides subjective responses, and the hearing healthcare professional uses this data for fitting. No MRMC study or AI assistance is mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is inherently not standalone in terms of interpretation or final action. While the software generates stimuli and collects data, a human hearing healthcare professional is explicitly required to perform the test, interpret the results, and adjust hearing aid settings. The patient's "human-in-the-loop" subjective response is central to the LGOB test itself.

The document states: "The software which controls the system is incorporated into ReSound® ReSource II software (K945750) that runs as a standalone application or can be integrated under the Noah operating system (K942749)." This refers to the software application running on a PC, not the diagnostic device itself performing standalone interpretation.

7. The Type of Ground Truth Used

The "ground truth" for the LGOB test is the patient's subjective perception of loudness. The test relies on the patient indicating their perceived loudness ("Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible") for various sound stimuli. This subjective data, combined with objective audiometric threshold data (entered separately by the professional), forms the basis for calculating fitting recommendations.

The scientific validity of the method (Loudness Growth in Octave Bands) is established by the referenced scientific literature (Allen, Hall, and Jeng, 1988/1990), which provides the theoretical and empirical underpinnings for using subjective loudness scaling.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models. This device is not described as utilizing a machine learning algorithm that requires a training set. The software likely implements established algorithms for calculating fitting recommendations based on the LGOB data and audiometric thresholds, rather than learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning model is mentioned. The "ground truth" for the device's function is rooted in audiology principles and the subjective responses of the patient as described in point 7.

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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight X 4. Severe Configuration: ✓ 1. High Frequency - Precipitously Sloping

This air-conduction behind-the-ear hearing instrument, intended to amplify sound . pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13). . The device is manufactured and delivered completely assembled to the hearing aid . dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the . ReSound® Digital 2000-BT are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™ The predicate device has the ability to retain programs in memory, and, with the use of . the optional remote control, up to three programs are accessible. The ReSound® Digital 2000-BT, however, is remote control/programmer dependent, therefore, no programs are retained in the device if the device is turned off. The ReSound® Digital 2000-DP is programmed by the hearing health care professional with up to 4 different programs per ear via Noah based ReSound ReSource™ software. . The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.

The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.

Instead, the document is a 510(k) premarket notification letter from the FDA regarding the ReSound Digital 2000-BT hearing aid. It focuses on establishing substantial equivalence to a predicate device (ReSound BT4 Personal Hearing System™) based on design, intended use, performance specifications, and manufacturing.

Here's a breakdown of why the requested information isn't present:

• Acceptance Criteria and Reported Performance: The document outlines the functional similarities and differences between the new device and the predicate device, but it does not specify quantitative performance metrics or acceptance criteria for those metrics. For example, it mentions the device "is designed to compensate for hearing losses from mild to severe" but doesn't provide numerical thresholds for what constitutes "compensating."
• Study Details (Sample Size, Data Provenance, Experts, Adjudication): This type of detailed study information is typically found in clinical trial reports or performance evaluation summaries, which are not part of this 510(k) letter. The letter primarily focuses on regulatory approval based on equivalence.
• MRMC Comparative Effectiveness Study: There is no indication of a comparative effectiveness study involving human readers (or in this case, human users of hearing aids) with and without AI assistance.
• Standalone Performance: While the document describes the device's functionality, it doesn't present data from a standalone performance study in the way one might expect for an AI diagnostic device. The performance is implied to be similar to the predicate device.
• Ground Truth Type: For a hearing aid, "ground truth" would likely relate to objective measures of hearing improvement or speech intelligibility, but these are not detailed in this document.
• Training Set Sample Size and Ground Truth Establishment (for AI): Since this is a hearing aid and not an AI-driven diagnostic device in the modern sense (the "digital" refers to digital signal processing within the hearing aid, not a separate AI algorithm being trained on data), there's no mention of a training set or how ground truth for such a set would be established.

Summary based on the provided text:

The document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a performance study with explicit acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.

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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.

The ReSound® Stealth CIC, a completely-in-the-canal hearing device, is an air-conduction hearing instrument, intended to amplify and transmit sound to the ear. The device is powered by a standard hearing aid battery (type 5A). The device is a completely in-the-canal one-channel device with K-Amp™ technology.

This document is a 510(k) premarket notification for the ReSound® Stealth CIC hearing device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, many of the requested details about acceptance criteria and study particulars are not explicitly available or applicable in the provided text.

Here's an attempt to extract and infer the information based on the provided document:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen with clinical studies. Instead, it defines the device's characteristics and functionality and claims substantial equivalence to a predicate device (Philips XP CIC, 510(k) No. K921725). The "acceptance criteria" here are implicitly centered around these equivalence claims.

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 does not describe a specific "test set" for a clinical study with a sample size or data provenance. The basis for substantial equivalence is primarily through comparison to an existing predicate device and its known performance, along with specific design characteristics of the new device. No new clinical study data is presented.

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. As no new clinical test set was used to establish ground truth, no experts were involved in this capacity for the purpose of this 510(k) submission.

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

Not applicable. No new clinical test set was used, so no adjudication method was employed.

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, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.

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

Not applicable. This device is a hearing aid, which by its nature operates "with human-in-the-loop" (the wearer). There is no standalone algorithm performance that would be separated from human interaction in this context.

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

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence relies on:

• Performance specifications of the predicate device: The Philips XP CIC (K921725) sets the benchmark for performance, safety, and intended use as a legally marketed device.
• General understanding of hearing aid technology: The principles of amplification, power sources, manufacturing, and safety (e.g., maximum SSPL90) are established standards in the field.
• Engineering and design documentation: The internal data supporting the device's specifications (e.g., one-channel, K-Amp™ technology, battery type, SSPL90 levels) would have been used to demonstrate that it meets the expected performance characteristics comparable to the predicate.

8. The sample size for the training set

Not applicable. This submission does not describe a machine learning algorithm that requires a training set.

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

Not applicable. No training set was used.

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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity:
X 2. Mild
X 3. Moderate
X 4. Severe

Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat

Other
X 1. Low tolerance To Loudness

This air-conduction in-the-ear hearing instrument, intended to amplify sound pressure waves . and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
The device is powered by a standard type 13 hearing aid battery (type 312 for the half-shell . option).
The device is manufactured and delivered completely assembled to the hearing aid dispenser ● using materials and techniques widely used by other manufacturers of hearing devices.
The intended use, performance specifications, functions and operations of the ReSound® ED4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System™ ED3.
The ability to program digitally the fitting parameters of the hearing device is the same as in . the ReSound® Personal Hearing System™ ED3, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control.

The provided document is a 510(k) premarket notification for a hearing aid, the ReSound ED4 Personal Hearing System™. It asserts substantial equivalence to a predicate device, the ReSound Personal Hearing System ED3a.

This document does not contain acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it asserts substantial equivalence to a previously cleared device (ReSound Personal Hearing System ED3a, K951379) based on the following justifications:

• Intended Use: The device is an air-conduction in-the-ear hearing instrument intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, designed to compensate for hearing losses from mild to severe. This is essentially identical to the predicate device.
• Power Source: Powered by a standard type 13 hearing aid battery (type 312 for half-shell option).
• Manufacturing: Manufactured and delivered completely assembled using widely used materials and techniques.
• Performance Specifications/Functions: Intended use, performance specifications, functions, and operations are essentially identical to the predicate device.
• Programmability: Ability to program digitally the fitting parameters and adjust sound processing/volume via ultrasound remote control is the same as the predicate device.

Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria and a study design because this information is not present in the provided text.

The document focuses on the regulatory process of demonstrating substantial equivalence, which primarily relies on comparing the new device to a legally marketed predicate device, rather than presenting new performance study data against pre-defined acceptance criteria for the new device itself.

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to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe.

This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries. The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the Audallion® II Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™. The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® BT4 Personal Hearing System™, as is the ability to change the characteristics of the sound processing and adjust the volume. The Audallion® II Hearing System has the ability to retain up to four programs in memory, whereas the predicate device has the ability to retain two.

The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for the Audallion® II Hearing System, submitted as a 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to a predicate device, the ReSound® BT4 Personal Hearing System™.

The concept of substantial equivalence in 510(k) submissions means demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that the new device has the same intended use as the predicate and either the same technological characteristics or, if different technological characteristics, that they do not raise different questions of safety and effectiveness and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

Critically, this document describes a regulatory submission for substantial equivalence based on technological characteristics and intended use similarity, not on clinical performance studies with specific acceptance criteria that one would typically use to "prove the device meets acceptance criteria" in the way clinical diagnostic or AI-driven devices are evaluated today.

Therefore, I cannot populate most of the requested fields because the provided text does not contain information about:

• Specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or other quantitative measures.
• A "study" designed to prove the device meets such criteria using a test set of data.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for performance evaluation.
• MRMC or standalone comparative effectiveness studies.
• Training set details for an algorithm (as this device is a hearing aid, not an AI algorithm in the modern sense).

Here's how I can address the prompts based only on the provided text, highlighting what is and isn't available:

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

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

• Not applicable / Not provided. The document does not describe a performance study with a test set. The basis for substantial equivalence is a comparison of technological characteristics and intended use, not statistical performance on a dataset.

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 / Not provided. There was no test set requiring expert ground truth establishment for performance evaluation in the context of this 510(k) summary.

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

• Not applicable / Not provided. No test set or expert adjudication process 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

• No. This is a hearing aid, not an AI-driven diagnostic device or one that involves human "readers" interacting with an AI. No MRMC study or AI assistance is mentioned.

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

• No. This device is a hearing aid, which is a standalone device in its operation (it amplifies sound for the user). However, it's not an "algorithm only" in the sense of a software-based diagnostic tool, nor is "standalone performance" evaluated in the context of an algorithm's output vs. ground truth. Its "performance" is inherent to its function as a hearing aid.

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

• Not applicable / Not provided. No external "ground truth" for performance evaluation was used beyond the comparison to the existing predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable / Not provided. This document is not describing an algorithm that requires a training set.

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

• Not applicable / Not provided. No training set is mentioned.

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This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.

This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
The device is powered by a standard hearing aid battery (type 13).
The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
The intended use, performance specifications, functions and operations of the ReSound® BT4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT.
The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® Personal Hearing System BT, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control. The ReSound® BT4 Personal Hearing System™ and the predicate device have the ability to retain two programs in memory.
The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.

This document is a 510(k) summary for the ReSound® BT4 Personal Hearing System™. It is a premarket notification for a medical device and provides very limited information about performance or a clinical study in the way a modern clinical trial summary would.

Based on the provided text, the device is a hearing aid, and the submission is focused on demonstrating substantial equivalence to a predicate device (ReSound® Personal Hearing System BT, marketed as BT2, K912665/A).

Therefore, it is highly unlikely that the typical "acceptance criteria" and "study proving device meets criteria" as defined for a diagnostic AI/ML device (which is what these questions usually relate to) would be present in this type of document from 1996 for a hearing aid.

Here's an attempt to answer the questions based only on the provided text, acknowledging that most questions cannot be answered directly from this document:

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

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative performance data from a study. Instead, it asserts substantial equivalence based on the following general points:

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 provided in the document. As this is a 510(k) for a hearing aid from 1996, it's highly improbable that a "test set" in the context of an AI/ML algorithm's performance evaluation was used or would be reported in this manner. The "study" here is demonstrating equivalence, not necessarily a performance trial on human subjects with a defined test set.

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 provided and is not applicable to the type of regulatory submission presented.

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

This information is not provided and is 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

A MRMC study as described (comparing human readers with/without AI assistance) was not done and is not applicable to this 1996 hearing aid submission.

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

A standalone algorithm performance study as described is not applicable to this device. The device itself is a hearing aid, not an AI algorithm.

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

The concept of "ground truth" as typically used for AI/ML device evaluation is not applicable here. The "truth" being established is that the new device is substantially equivalent to an existing, legally marketed device.

8. The sample size for the training set

This information is not provided and is not applicable. There is no indication of an AI/ML training set in the document.

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

This information is not provided and is not applicable. There is no indication of an AI/ML training set in the document.

Summary based on the provided text:

The document is a 510(k) summary for a hearing aid, demonstrating substantial equivalence to a predicate device. It focuses on functional and operational similarities rather than detailed performance metrics from a clinical study with acceptance criteria often seen for imaging or AI/ML-based diagnostic devices. Therefore, most of the requested information, which pertains to AI/ML or extensive clinical trial performance, is not present or applicable.

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This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderate.

The device is powered by a standard hearing aid battery (type 10A). The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability of the hearing aid dispenser to program digitally the fitting parameters of the ReSound® CC4 hearing device is the same as in the ReSound® IC4. The ability to change the characteristics of the sound processing and to adjust the volume via an optional remote control is the same as that offered by the commercial device, the ReSound® IC4. The algorithm used by the ReSound® computerized fitting system to compute sets of fitting parameters is similar to that used for the ReSound® IC4 with adjustments made for the acoustic differences between the IC4 and the ReSound® CC4.

This document (K964115) is a 510(k) premarket notification for a hearing aid, the ReSound® CC4 Personal Hearing System™. It is seeking substantial equivalence to a predicate device, the ReSound® Personal Hearing System™ ED4-C (K951067).

The information provided in this 510(k) summary is insufficient to answer many of the questions asked, as it is focused on establishing substantial equivalence based on design and operational similarities, rather than a clinical performance study with acceptance criteria and detailed reporting of device performance against a ground truth.

Here's an attempt to address your prompts based on the available information, with significant caveats where information is missing:

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

Based on the document, there are no explicitly stated acceptance criteria in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity) for the new device. The acceptance criteria for this 510(k) are implicit: that the new device is substantially equivalent to the predicate device in its intended use, technology, and performance specifications.

The document does not describe a study that proves the device meets specific performance-based acceptance criteria. Instead, it asserts substantial equivalence based on design and functional similarities to a previously cleared device. There is no mention of a clinical trial or performance study against a specific ground truth for the CC4 device in this summary.

The remaining questions cannot be answered from the provided text as they pertain to clinical performance studies, which are not described in this 510(k) summary. This document focuses on demonstrating substantial equivalence, not on presenting novel clinical performance data with a test set, expert ground truth, or a multi-reader study.

Here's why each cannot be answered:

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

• Not applicable / Not provided. No clinical performance test set is described.

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 / Not provided. No test set or ground truth establishment process is described.

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

• Not applicable / Not provided. No test set or adjudication process 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 / Not provided. This is a hearing aid, not an AI diagnostic imaging device for human readers/interpreters. No MRMC study is mentioned.

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

• Not applicable / Not provided. While a hearing aid has "standalone" performance, the 510(k) doesn't describe a formal study of its performance in this context against a clinical outcome. Its function is to amplify sound, and its "performance" is implicitly tied to its effect on the user's hearing, which is not detailed in a clinical study here. The "algorithm" mentioned refers to the fitting system's software, not an AI for diagnosis.

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

• Not applicable / Not provided. No ground truth defined for a performance study.

8. The sample size for the training set

• Not applicable / Not provided. No training set for a machine learning algorithm in the context of clinical performance is described. The "fitting system algorithm" is likely a rule-based or signal processing algorithm, not a machine learning model requiring a "training set" in the typical sense.

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

• Not applicable / Not provided. No training set or ground truth establishment is described.

In summary: This K964115 document demonstrates substantial equivalence for a hearing aid based on similarities in intended use, technology, and performance specifications to a predicate device. It does not contain the details of a clinical performance study with explicit acceptance criteria and corresponding performance metrics against a defined ground truth, as would be expected for a device requiring such data to demonstrate safety and effectiveness.

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These air-conduction hearing instruments are intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

These devices are powered by a standard hearing aid battery (type 13). These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the ReSound® Personal Hearing Systems EDR Encore Series are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System ED3-E. The ability to program digitally the fitting parameters of the hearing devices and the ability of the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. The EDR-E, EDR-ES, and EDR-EV are dispenser programmable, whereas the EDR-P1 programming is factory preset and may be reprogrammed at the factory only.

I am sorry, but the provided text from the "ReSound® Personal Hearing Systems EDR Encore Series" document is a summary of safety and effectiveness for a medical device (hearing aids) and does not contain the specific information required to answer your request.

The text describes:

• The product: ReSound® Personal Hearing Systems EDR Encore Series (Models EDR-E, EDR-ES, EDR-EV, and EDR-P1).
• Its predicate device: ReSound® Personal Hearing System ED3-E.
• Its intended use: To amplify sound for mild to moderately-severe hearing loss.
• Its power source: Standard hearing aid battery (type 13).
• Manufacturing details: Assembled using common techniques and materials.
• Key features: Digital programming ability and program retention.
• Differences in programming: EDR-E, EDR-ES, EDR-EV are dispenser programmable; EDR-P1 is factory preset.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance tests.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided input.

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. This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

. This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.
The device is powered by a standard hearing aid battery (type 13). .
The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
The intended use, performance specifications, functions and operations of the ReSound® . Personal Hearing System EDR-7 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System ED3-E.
. The ability to program digitally the fitting parameters of the hearing device and the ability of the device to retain the program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. Seven programs are factory preset for the EDR-7 from which the dispenser may select for the fitting. The seven factory preset programs may not be modified by the dispenser via a programmer or by any other means. Modifications in the preset programming may only be accomplished at the factory.

The provided document is a summary of safety and effectiveness for the ReSound® Personal Hearing System EDR-7, comparing it to a predicate device for substantial equivalence. It does not describe a study involving acceptance criteria and device performance in the way typically expected for an AI/ML device or a medical device with measurable diagnostic or treatment outcomes evaluated against specific performance metrics.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) because the document does not contain this type of study or information.

Instead, the document focuses on demonstrating substantial equivalence for a hearing aid by comparing its features, intended use, and manufacturing processes to a previously cleared device. Key points from the document indicating this are:

• Substantial Equivalence Statement: "Substantial equivalence for the ReSound® Personal Hearing System EDR-7 to the predicate device, the ReSound® Personal Hearing System ED3-E. 510(k) No. K950319, February 8, 1995, is based on the following:"
• Comparison Points: The bullet points describe similarities in:
  • Intended use (amplifying sound for hearing loss).
  • Power source (standard battery).
  • Manufacturing (materials and techniques).
  • Performance specifications, functions, and operations.
  • Digital programming ability and program retention.

This is a regulatory submission for a traditional medical device demonstrating equivalence, not a performance study as outlined in your request.

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These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe.

These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe. These devices are powered by a standard hearing aid battery (type 13). These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability to program digitally the fitting parameters of the hearing devices and the ability of . the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.

This document is a summary of safety and effectiveness for a hearing aid device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Specifically, the document discusses substantial equivalence to a predicate device based on features, intended use, and programming capabilities. It does not present performance metrics, study methodologies, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.

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