(28 days)
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.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).