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The Cochlear Baha BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), for the following patients and indications:

• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
• Bilateral fitting of the BP100 is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is also indicated for any patient who is indicated for an airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Baha implant system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality. Baha sound processors can also be fitted as external (non-implanted) bone-conduction vibrators with either the Baha Headband or Baha Softband as an alternative to a conventional bone-conduction hearing aid.

The Baha BP100 will be the newest addition to a current family of three marketed sound processors for use with the Baha auditory osseointegrated implant, or with the Baha Headband/Softband setup. In its initial release, it will provide a moderate gain ear-level sound processor that will serve as a premium-feature option to the currently marketed Baha Divino. At a later date, the BP100 platform may be used to provide a range of programmable products to meet end-user needs.

The provided text describes a 510(k) premarket notification for the Cochlear Baha BP100, a bone conduction hearing aid. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a de novo clinical study with specific acceptance criteria and performance metrics.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new clinical study. Instead, the primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.

The reported device performance is framed in terms of comparability to the predicate Baha Divino.

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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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A wearable sound-amplifying device that is intended to help compensate for impaired hearing. Sounds are electronically amplified and transmitted to the ear.

PRISMA Behind the Ear and Custom Hearing Instruments are digitally programmable instruments. The dispenser programs the instrument using Siemens PC CONNEXX software with HiPro ™ hardware (K942749), Siemens Personal Programmer 2000, or UNITY with HiPro hardware This device is intended to compensate for a wide range of moderate to severe hearing losses including flat, ski-slope and reverse slope losses. It features digital control of a highly flexible digital signal processor. Up to 32 digitally adjustable parameters and two listening situations (memories) are accessible to shape and modify the instrument's response, depending on the model configuration. These include: Channel Delineation, Curvilinear Compression, Linear Compression, Syllabic Compression, Dual Compression, Voice Activity Detection System, Channel Gain, Cross Channel Shaping, Interchannel coupling, Twin Microphone System/Direction Mic, Low level Squelch, Second Program. Assembled from standard components that are widely utilized by other hearing aid manufacturers. Technical specifications comply with s3.22-1987 ANSI Specifications. The frequency response of the product is dictated by the individual Audiogram from each client and the settings of the programmable controls. User adjustable controls may be found on the Behind-the-Ear model which include a Microphone-Telecoil-Off (M-T-O) switch, and a momentary push-button switch to change between the two stored memories. Depending on the specific configuration of the instrument as ordered by the hearing instrument professional, some of these user controls may not be present. With the custom products, PRISMA comes standard with no user adjustable controls unless specifically requested by the hearing instrument professional, in which case a push button switch and/or directional microphone is available.

This document is a 510(k) premarket notification for the Siemens PRISMA Digital Hearing Aid. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance criteria through a study with acceptance criteria.

Therefore, many of the requested elements for a study demonstrating acceptance criteria are not applicable to this type of regulatory submission. The document explicitly states that the device is "substantially equivalent to other Behind the Ear (BTE) and Custom hearing aids... on the market" and that "Technical specifications comply with s3.22-1987 ANSI Specifications." This implies that the device is expected to meet the performance standards set by the ANSI specification, but no specific study demonstrating this against acceptance criteria is described in the provided text.

Here's an breakdown of the requested information based on the provided text, highlighting what is not applicable to a 510(k) for a hearing aid of this nature:

1. Table of Acceptance Criteria and Reported Device Performance:

A table of explicit acceptance criteria and reported device performance from a specific study is not provided in this 510(k) summary. The document states:

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

• Not applicable for this 510(k) submission. The document does not describe a clinical study or performance testing with a specific "test set" and associated sample size or data provenance in the context of demonstrating adherence to performance acceptance criteria. The claim is for substantial equivalence to existing devices and compliance with ANSI standards.

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

• Not applicable. As no specific "test set" for performance evaluation is described, there is no mention of experts establishing ground truth for such a set.

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

• Not applicable. No test set or expert adjudication 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 hearing aid, not an AI-powered diagnostic or interpretive system that would involve "human readers" or "AI assistance" in the sense of an MRMC study.

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

• Not applicable. This question is typically relevant for AI/algorithm-based diagnostic devices. The Siemens PRISMA is a hearing aid, whose performance is inherent in its electroacoustic properties and its ability to amplify sound for a user, as adjusted by a dispenser. Its "performance" is functional, not algorithmic in the context of standalone diagnostic capabilities.

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

• Not applicable. No specific ground truth is described for performance evaluation. The device's "ground truth" for efficacy is implicitly its ability to meet the ANSI standards and amplify sound as intended for individuals with hearing loss, which is assessed through standard audiological practices rather than a 'ground truth' for an AI model.

8. The sample size for the training set:

• Not applicable. This device is hardware with digital programming capabilities, not a machine learning model developed with a training set.

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

• Not applicable. As above, no training set or its associated ground truth is relevant or mentioned for this device.

In summary: The provided document is a 510(k) premarket notification affirming substantial equivalence and compliance with established ANSI standards for hearing aids. It does not contain a detailed study proving the device meets specific acceptance criteria in the manner that a clinical trial or AI performance study would. The acceptance criteria are implicitly the ANSI standards and the device's functional characteristics typical of its predicate devices.

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The ReSound® Real Ear Loudness Mapping (RELM) System is substantially equivalent to currently marketed audiometric diagnostic testing equipment and hearing aid analysis systems such as: the ReSound® Portable Prescriptive Programming (P) System and the Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer". The software for the system is substantially equivalent to the ReSound® ReSource™ software that runs under the Noah" operating system.

The RELM test equipment is comprised of proprietary PC software, a sound field speaker system, and a real ear probe microphone. Similar to the Loudness Growth in Octave Bands (LGOB) Test provided with the ReSound® P System, this new hearing device fitting method is designed to measure loudness growth in hearing-impaired subjects in sound field, instead of with insert phones, in the unaided and aided conditions, through the use of subjective and objective measures, thus integrating both electroacoustic and psychoacoustic test capabilities.

The ReSound® Real Ear Loudness Mapping (RELM) System is comprised of proprietary PC software, a sound field speaker system, and a real ear probe microphone. This system measures loudness growth in hearing-impaired subjects in sound field, in the unaided and aided conditions, through the use of subjective and objective measures. It integrates both electroacoustic and psychoacoustic test capabilities. The system produces computer generated stimuli delivered via speakers, measures the intensity of the signals via a probe microphone in the patient's ear canal, and displays the values in the form of frequency intensity curves on the PC screen. It also incorporates the patient subjective response data in the calculation of target response curves for determining the hearing device fitting parameters.

The provided text is a 510(k) Premarket Notification for the ReSound® Real Ear Loudness Mapping (RELM) System. It describes the device and claims substantial equivalence to existing devices. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document focuses on:

• Description of the RELM System: Proprietary PC software, sound field speaker system, real ear probe microphone, integrating electroacoustic and psychoacoustic test capabilities.
• Functionality: Measures loudness growth in hearing-impaired subjects in sound field (unaided and aided conditions) using subjective and objective measures. It incorporates patient subjective response data for calculating target response curves and fine-tuning hearing device parameters.
• Claim of Substantial Equivalence: To existing audiometric diagnostic testing equipment and hearing aid analysis systems (ReSound® Portable Prescriptive Programming (P) System and the Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer) and software (ReSound® ReSource™). This equivalence is based on similar functionalities like generating stimuli, measuring signal intensity, and displaying frequency intensity curves, with the RELM system adding patient subjective response incorporation.
• Safety and Effectiveness: States that its use does not significantly affect the safety or effectiveness of currently marketed ReSound® Personal Hearing Systems.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided text.

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