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The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic QAE and EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Biologic OAE and EP families of products is to be performed under the prescription and supervision of other trained health care professional.

The Bio-logic Hearing Screening products, including the OAE and ABR test instruments Scout/AuDX and ABaer Cub, are intended to be used for the purpose of testing for hearing loss in patients of all ages, but primarily in infants. This new product, ABaer Cub with OAE, is the integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub, with additional OAE software functions added to the Pocket PC host computer for the ABaer Cub. The ABaer Cub predicate device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub with OAE device performs these same functions in the same ways, but has the added capability of performing the OAE tests of the Sport/AuDX predicate device, all within the same hardware package as the ABaer Cub. The Sport/AuDX predicate device can be used in either a stand-alone (AuDX) or host-connected (Sport) mode. The same DSP software is used in both types of box. The primary difference between the two products is that the Sport requires the use of a host computer for user control information and to store and display the data returned from the Sport box. For the AuDX, all user control and display is right at the AuDX box, making this a fully portable test instrument but with limited control and display capability. However, after an AuDX test is completed, it can be connected to a host computer to download test data for display on the host computer screen if desired. This same Sport/AuDX DSP software functionality has been incorporated into the ABaer Cub box. Much of the Sport host computer display software has been incorporated into the ABaer Cub Pocket PC (host computer), resulting in a completely battery-powered, portable hand-held test instrument capable of performing both the Automated OAE and ABR tests. The Sport OAE predicate device uses a desktop or laptop computer instead of the Pocket PC. The electronic hardware is the same as the ABaer Cub hardware used in that predicate device. Because both the Pocket PC and the ABaer Cub unit are battery powered, this significantly improves the portability and usability of the device over that of the Sport OAE predicate device. The ABaer Cub software for control of this device is a combination of the Sport and ABaer Cub predicate device software, with some GUI changes necessary in the Sport OAE software to modify the graphics display for use with the smaller Pocket PC LCD screen. The host software for the Sport/AuDX OAE predicate device is written in the C++ programming language for the Windows 95/98/ME operating system, whereas the host software for the ABaer Cub is written in the C++ programming language for the Windows Pocket PC operating system. Together, these software additions implement the same functionality and perform the same intended use as both predicate devices, but with improved portability and ease-of-use.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for the Bio-logic ABaer Cub with OAE device. It describes the device, its intended use, and establishes substantial equivalence to predicate devices (Sport/AuDX and ABaer Cub) based on the functions and integration of existing technologies.

Specifically, the text is focused on:

• Device Description: Explaining that the new device integrates the OAE functions of the Sport/AuDX and the ABR functions of the ABaer Cub into a single portable unit.
• Predicate Devices: Identifying the legally marketed devices to which the new device is substantially equivalent.
• Intended Use: Stating the purpose of the device (screening for hearing loss, especially in infants, and recording/analysis of physiological data for auditory disorders in all ages).
• FDA Clearance: The letter from the FDA stating that the device is substantially equivalent to predicate devices and can be legally marketed.

Therefore, I cannot provide the requested information in the table or the study details because they are not present in the provided document.

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The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, the ABaer Cub, like it's predicate device, the ABaer, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. The ABaer Predicate Device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub device performs these same functions in essentially the same ways, but has hardware and software modifications and improvements over the Predicate device, primarily to enhance portability and ease of use. The ABaer Cub device incorporates the same POVR algorithm for the same purpose, to yield high-quality test results in the shortest possible time. The feature modifications for this new device include the use of a Personal Digital Assistant (PDA) or "Pocket PC" which can be hand-carried separately or mounted right on the ABaer box, resulting in a completely battery-powered, portable hand-held test instrument. The electronic hardware is very similar in design to the ABaer hardware used in the Predicate Device. The enclosure has been made slightly larger (deeper) to allow space to incorporate a rechargeable battery inside the unit. New circuitry for charging the battery has also been added to the unit, and the small LCD display in the ABaer has been removed from the ABaer Cub. The functions of the hardware are substantially the same as those of the Predicate Device hardware. The ABaer predicate device communicates test information and results to a separate host computer (desktop PC or laptop) through a serial communications port. In the ABaer Cub, this host computer is now a PDA or "pocket PC" (for instance, the Hewlett-Packard Jornada) which can be affixed right on the ABaer unit or hand-carried separately. The ABaer Cub software for control of this device is a simplified subset of the ABaer Predicate Device software, with some GUI changes necessary to enhance the graphics display for use with the smaller PDA LCD screen. The host software for the Predicate Device is Windows 95/98/ME based, whereas the host software for the ABaer Cub is Windows CE based. The C++ programming language is used in both cases. Together, these minor hardware and software changes implement the same functionality and perform the same intended use as the Predicate Device, but with improved portability and ease-of-use.

The provided text is a 510(k) Summary for the Bio-logic ABaer Cub device, which is a modification to an existing Evoked Potential product. The document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or the comprehensive study design typically found in a clinical performance study report.

Based on the provided text, here's what can be extracted and what information is not available:

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

This information is not explicitly stated in the provided 510(k) summary. The document describes the device modification and its functions but does not present specific acceptance criteria or quantitative performance metrics against those criteria. It emphasizes that the new device performs the "same functions in essentially the same ways" 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)

This information is not available in the provided text. The document does not describe any specific test set or clinical study conducted with human subjects to evaluate the ABaer Cub's performance.

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. As there is no described test set or clinical study to establish ground truth, the number or qualifications of experts are not mentioned.

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

This information is not available. Without a described test set or clinical study, there is no mention of an adjudication method.

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 applicable/not available. The ABaer Cub is described as an "Evoked Response Auditory Stimulator" and "Evoked Potential system" that uses an algorithm (POVR) to optimize signal quality and screening function. It is not an AI-based diagnostic tool for which a MRMC study comparing human readers with and without AI assistance would typically be conducted. The "Pass/Refer recommendations" can be reviewed and overridden by a qualified health care professional, but this is not framed as an AI assistance scenario in the context of improving human reader performance.

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

The device incorporates the "Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion." The document states that the ABaer Cub software "does not make any final decisions that result in any direct forms of diagnosis or treatment. The Pass/Refer recommendations of the automated screening process in the ABaer Cub can be reviewed...and may be modified, overridden or deleted as determined by the qualified user." This implies that while the algorithm provides automated recommendations, it is not purely standalone in terms of clinical decision-making. The document doesn't provide a specific study to evaluate the algorithm's standalone performance.

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

This information is not available. No specific ground truth methodology is described for evaluating the device's performance. The device is a modification of a predicate device, and the focus is on demonstrating that the modifications do not adversely affect safety and effectiveness, rather than establishing new performance benchmarks against a gold standard.

8. The sample size for the training set

This information is not available. Since the device is a modification of an existing product and the focus is on hardware and software changes for portability and ease of use, there is no mention of a training set for a new algorithm or model. The POVR algorithm is described as being incorporated from the predicate device.

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

This information is not available. As there is no described training set, the method for establishing its ground truth is not mentioned.

Summary of available information regarding acceptance criteria and study proving device meets criteria:

The provided document is a 510(k) summary for a device modification, not a clinical study report. Its primary purpose is to demonstrate substantial equivalence to a predicate device. Therefore, it focuses on describing the device, its intended use, and how the modifications do not adversely affect safety and effectiveness compared to the predicate. It states:

• "This new ABaer Cub device performs these same functions in essentially the same ways, but has hardware and software modifications and improvements over the Predicate device, primarily to enhance portability and ease of use."
• The ABaer Cub incorporates "the same POVR algorithm for the same purpose, to yield high-quality test results in the shortest possible time."
• "Together, these minor hardware and software changes implement the same functionality and perform the same intended use as the Predicate Device, but with improved portability and ease-of-use."
• "The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders."

The document relies on the established safety and effectiveness of the predicate device and asserts that the modifications do not introduce new safety or effectiveness concerns. The "study" proving the device meets criteria primarily consists of:

• Design and incorporation according to internal Product Development procedures meeting ISO-9001, EN-46001, and FDA QSR Design Control specifications.
• A detailed Hazard/Risk analysis using Fault Tree analysis (FTA) and a Risk Assessment in accordance with EN-1441, with an addendum for the ABaer Cub design.
• Comparison of technological characteristics of the ABaer Cub relative to the predicate ABaer device to "demonstrate that this new ABAER Cub device has no significant differences which would adversely affect product safety and effectiveness."

No specific clinical performance study with defined acceptance criteria, sample sizes, or ground truth methodologies is detailed in this 510(k) summary for the modified device.

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