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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
✓ 2. Mild
✓ 3. Moderate
✓ 4. Severe
Configuration:
✓ 1. High Frequency Precipitously Sloping
✓ 2. Gradually Sloping
✓ 3. Reverse Slope
✓ 4. Flat
✓ 5. Other
Other:
✓ 1. Low tolerance to Loudness

Behind-the-Ear (BTE) Hearing Aid

The provided text introduces the Miracle-Ear Model DBS Hearing Aid and states that its technical characteristics are assessed using the ANSI S3.22-1987 methodology. It also mentions that the device is substantially equivalent to the Oticon Digifocus Compact BTE, which was cleared under 510(k) # K961059. However, the document does not provide acceptance criteria or details of a study that proves the device meets specific performance criteria. The FDA letter confirms the device's substantial equivalence but does not describe the specific tests or results that led to that determination.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer the questions based on the limited information:

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

The document states that "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This implies that the acceptance criteria would be defined by this standard, and the device's performance would be measured against it. However, the specific acceptance criteria values (e.g., minimum gain, maximum output, harmonic distortion limits from ANSI S3.22-1987) and the actual reported device performance values are not provided in this document.

2. Sample sized 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. The document refers to "performance data" but does not specify the sample size, data origin, or study design (retrospective/prospective).

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 applicable as the document describes a hearing aid, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The performance testing for hearing aids typically involves objective acoustical measurements against a standard.

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

This information is not applicable for the type of device and performance testing described. Adjudication is not typically used for objective acoustical measurements of hearing aid performance.

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 as the device is a hearing aid and not an AI-powered diagnostic tool used by human readers for interpretation.

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

This information is not applicable as the device is a hearing aid. Its "standalone performance" refers to its acoustical output, which would be measured directly against the standard, not an algorithm's performance.

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

For a hearing aid, the "ground truth" for performance would be objective acoustical measurements obtained by following the methodology outlined in the ANSI S3.22-1987 standard. This standard prescribes how to measure various performance characteristics such as frequency response, full-on gain, maximum output (OSPL90), and harmonic distortion.

8. The sample size for the training set

This information is not applicable. Hearing aids are physical devices, and their performance is typically evaluated through direct measurement and engineering specifications rather than a "training set" used for machine learning.

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

This information is not applicable for the reasons stated in point 8.

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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: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other ski-sloping
Other: Low tolerance to Loudness, Compression Limiting, Loudness Growth Compensation

CIC, ITE and BTE Hearing Aids

The provided document describes a 510(k) submission for the "Miracle-Ear Programmable Sharp Dynamic Hearing Aids". However, it is a notification of intent to market a device and focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through performance data.

Therefore, many of the requested items cannot be fully extracted from this document because it does not contain a study report with performance metrics, ground truth establishment, or sample sizes related to clinical validation.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This implies that the acceptance criteria are likely derived from or comply with the standards set forth in ANSI S3.22-1987. However, the specific acceptance criteria (e.g., maximum output, frequency response characteristics, total harmonic distortion limits) and the reported device performance against those criteria are not provided in this document. The table in Appendix B only lists technical characteristics and fit details, not specific performance metrics.

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

• Sample Size (Test Set): Not specified in the provided document. The 510(k) summary focuses on substantial equivalence rather than a detailed clinical trial's test set.
• Data Provenance: Not specified in the provided document.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

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:

• MRMC Study: Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool that would involve human "readers" or AI-driven improvements in diagnostic accuracy.

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

• Standalone Performance: Not applicable in the context of AI algorithms. This refers to the standalone performance of the hearing aid itself, which would be assessed against ANSI standards. The document states that the ANSI S3.22-1987 methodology is used to test performance, implying a standalone assessment of the device's electroacoustic characteristics. However, the results of this standalone testing are not provided.

7. The type of ground truth used:

• Type of Ground Truth: For hearing aids, "ground truth" typically refers to objective electroacoustic measurements against established performance standards (such as ANSI S3.22-1987). It also involves fitting parameters based on an individual's audiogram. Clinical efficacy might be assessed through user perception and audiological benefits, but comprehensive "ground truth" like pathology or outcomes data in the AI diagnostic sense is not relevant here. The clinical indications for use are based on the amplification of sound for individuals with impaired hearing, linked to audiogram severity and configuration (e.g., slight to severe hearing loss, high frequency sloping, gradually sloping, etc.).

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable in the context of machine learning. This device does not appear to be an AI/ML driven device that requires a "training set."

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

• Ground Truth Establishment (Training Set): Not applicable, as there is no indication of an AI/ML training set.

Summary based on the document:

The document is a 510(k) premarket notification for a hearing aid, seeking substantial equivalence to a predicate device. It explicitly states that the device utilizes the ANSI S3.22-1987 methodology for performance testing. This standard would define the acceptance criteria and the methods for obtaining performance data. However, the actual performance data against these criteria is not included in this summary. The "Indications For Use" (Page 3) specify the types and severities of hearing loss the device is intended to address, but these are indications, not performance metrics or acceptance criteria per se.

In essence, the document serves as a regulatory clearance document based on substantial equivalence, rather than a detailed scientific study report demonstrating the device's performance against specific acceptance criteria.

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General Indications: A. 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 ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other: ✓ 1. Low tolerance to Loudness B. Specific Indications (Only if appropriate): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data).

To amplify and transmit sound to the ear.

The provided text is a 510(k) summary for the Miracle-Ear Model DSF Hearing Aid. It declares the device substantially equivalent to a previously cleared device (Oticon Digifocus, K964683) and outlines its intended use and technical characteristics. However, it does not contain information about acceptance criteria, detailed device performance studies, sample sizes for testing or training, expert qualifications for ground truth, or adjudication methods.

The document from which the following information is extracted is a 510(k) summary, which often focuses on establishing substantial equivalence rather than detailing comprehensive clinical study results or performance against specific acceptance criteria. While it mentions the use of ANSI S3.22-1987 methodology for performance data, it doesn't present the data itself or define acceptance criteria for that data in this document.

Therefore, the following table and subsequent sections will indicate where the requested information is not provided in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

Additional Information Not Provided in the Document:

Due to the nature of this 510(k) summary, specific details regarding performance studies, ground truth establishment, and sample sizes are not included.

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

• Sample Size: Not provided.
• Data Provenance: Not provided. The document mentions using ANSI S3.22-1987 methodology for testing, which implies standardized acoustic measurements, but does not specify if human subjects and a test set were used, or where such data would originate.

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 or ground truth establishment by experts is detailed in this 510(k) summary. Performance data, according to the document, relies on the ANSI standard, which primarily involves objective acoustic measurements.

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

• Not applicable. No adjudication method is 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:

• Not applicable. This is a hearing aid, not an AI-assisted diagnostic device, and no MRMC study information is provided.

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

• Not applicable. This device is a hearing aid, not an algorithm. Its performance is measured through its acoustic output and suitability for individuals.

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

• Not explicitly stated. For hearing aids tested per ANSI S3.22-1987, ground truth would typically relate to objective electroacoustic performance metrics (e.g., gain, output, frequency response, distortion) rather than clinical "ground truth" derived from expert consensus or pathology in the diagnostic sense. The "fit" based on "individual users audiogram" implies audiometric data is relevant.

8. The sample size for the training set:

• Not applicable. This device is a hardware product, not a machine learning algorithm requiring a training set.

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

• Not applicable. As above, this device does not involve a "training set" in the context of machine learning.

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To amplify and transmit sound to the ear.

Dahlberg Hearing Aid with multi-channel compression circuit

This document is a 510(k) summary for a Dahlberg Hearing Aid. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K964530) rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically seen for AI/ML or new clinical diagnostic devices.

Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text. I will provide what information is available and indicate where information is missing or not relevant to this type of submission.

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

Based on the provided text, the "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to a predicate device. The performance data is primarily technical and measured against industry standards rather than clinical outcomes.

Note: The document does not provide specific numerical performance data (e.g., gain, frequency response curves) but states that the methodology used is ANSI S3.22-1987, which is a standard for hearing aid measurement.

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. This 510(k) summary does not describe a clinical study with a "test set" of patient data. The evaluation for this type of device is primarily based on technical specifications and comparison to a predicate device.

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 clinical ground truth establishment is described in this document.

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

• Not Applicable/Not Provided. No clinical 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 device is a hearing aid, not an AI/ML diagnostic tool, so an MRMC study related to human reader performance with AI assistance is not relevant.

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

• Not Applicable/Not Provided. This is a physical medical device (hearing aid), not an algorithm.

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

• Not Applicable/Not Provided (for clinical ground truth). The "ground truth" equivalent in this context is the adherence to ANSI S3.22-1987 standards for electroacoustic performance and the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not Applicable/Not Provided. No "training set" in the context of AI/ML is relevant to this submission.

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

• Not Applicable/Not Provided. No training set or associated ground truth establishment is relevant to this submission.

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To amplify and transmit sound to the ear.

CIC, ITC and ITE Hearing Aids

The provided document is a Summary of Safety and Effectiveness for a 1997 Dahlberg hearing aid device. This type of document for a Class I device from 1997 does not contain the detailed clinical study information requested in your prompt.

Here's why and what information can be extracted:

• Class I Devices: Class I devices are typically low-risk and often exempt from extensive premarket clinical studies. The regulatory pathway (510(k)) focuses more on demonstrating substantial equivalence to a legally marketed predicate device rather than providing new clinical performance data from human trials.
• 1997 Document: Regulatory expectations and the level of detail required in 510(k) submissions were significantly different in 1997 compared to today, especially concerning clinical study design and performance metrics for AI/software devices.
• Device Type: This is a physical hearing aid, not an AI software or diagnostic device. The concepts of "ground truth," "expert consensus," "training set," "test set," "MRMC studies," and "AI assistance" are not applicable to this type of device described in this kind of document. The "performance data" mentioned in the document refers to acoustic performance standards (like ANSI S3.22-1987) rather than clinical accuracy for a diagnostic task.

Therefore, I cannot fulfill your request for: Acceptance Criteria Table, Sample Sizes, Expert Information, Adjudication, MRMC studies, Standalone Studies, Ground Truth Types for Test/Training, and Training Set Size/Ground Truth Establishment.

The provided document simply does not contain this information. It focuses on:

• Substantial Equivalence: The primary "acceptance criteria" here is demonstrating that the new device is substantially equivalent to a previously cleared predicate device (Miracle-Ear Sharp Plus, K935265).
• Technical Characteristics: Performance is assessed against industry standards for acoustic output, not diagnostic accuracy.

Here's what little can be inferred from the provided text, but it doesn't align with your prompt's specific requests about AI/diagnostic device evaluation:

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

   • Acceptance Criteria (Implicit): Substantial equivalence to predicate device K935265. Meeting ANSI S3.22-1987 methodology for acoustic performance.
   • Reported Device Performance: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." (Specific performance values like gain, frequency response, output are not provided in this summary, but would have been in the full submission).

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

   • Not applicable / Not provided. This document does not describe a clinical "test set" in the context of diagnostic accuracy. Performance "testing" refers to acoustic measurements in a lab, not human trials.

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 is no "ground truth" established by experts for this type of device in this context.

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

   • Not applicable / Not provided.

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 device is a hearing aid, not an AI diagnostic tool.

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

   • Not applicable / Not provided.

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

   • Not applicable / Not provided.

8. The sample size for the training set

   • Not applicable / Not provided.

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

   • Not applicable / Not provided.

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To amplify and transmit sound to the ear.

BTE Hearing Aid

This document describes an Audiotone A-554 BTE hearing aid, which is a Class I medical device. However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

Therefore, I cannot fulfill your request for the detailed table and study information. The input focuses on the device's classification, intended use, technical characteristics (ANSI S3.22-1987 methodology for testing), and general specifications, but lacks the specific performance data and study details you've asked for.

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To amplify and transmit sound to the ear.

BTE Hearing Aid

The provided document is a Summary of Safety and Effectiveness for the Audiotone A-554H BTE hearing aid, dated January 27, 1997. It outlines the device details, classification, intended use, and substantial equivalence to a previously cleared device (Audiotone A-54SR, K941122).

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any details related to AI/algorithm performance, ground truth establishment, or sample sizes for training/test sets.

Therefore, I cannot fulfill your request for the following sections based on the provided input:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document states: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This indicates adherence to an industry standard for performance evaluation, but the specifics of acceptance criteria (e.g., minimum gain, maximum output, harmonic distortion limits) and the results against those criteria are not detailed in this summary. The "Substantially Equivalent to" section implies that its performance is considered comparable to the A-54SR, which was previously cleared, suggesting it meets similar performance standards, but no data is presented within this document to demonstrate that directly.

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To amplify and transmit sound to the ear.

BTE Hearing Aid

The provided text does not contain information about the acceptance criteria or a study proving that the Audiotone A-552 BTE device meets such criteria. The document is a "Summary of Safety and Effectiveness" which outlines basic device information, classification, intended use, and equivalence to a previously cleared device.

Therefore, I cannot fulfill the request for tables and descriptions regarding acceptance criteria and study details.

The provided text does NOT contain the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document states: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." While this specifies a standard used for testing, it does not provide the acceptance criteria (i.e., specific thresholds the device must meet to be deemed acceptable) nor the results of a study demonstrating compliance with those criteria.

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To amplify and transmit sound to the ear.

Dahlberg Power BTE

Based on the provided document and the nature of the device (a BTE Hearing Aid), this information does not contain the details necessary to answer your request.

Here's why and what's missing:

• Acceptance Criteria & Reported Device Performance: The document provides general characteristics of the device (device type, intended use, materials, assembly, power, fit). It states that Dahlberg "utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." However, it does not list specific acceptance criteria (e.g., minimum gain, maximum output, frequency response within a certain tolerance, distortion levels) or report any specific performance data against such criteria. For example, it doesn't say "Gain at 1000 Hz: 40 dB, Acceptance Criteria: 38-42 dB."

• Study That Proves the Device Meets Acceptance Criteria: Since no specific acceptance criteria or performance data are provided, there is also no description of a study that proves the device meets these criteria. The mention of "ANSI S3.22-1987 methodology" indicates a standardized testing method is used, but not the results or the study design for demonstrating compliance.

Therefore, I cannot populate the table or provide the requested information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in detailed performance reports, clinical study summaries, or validation protocols, which are not present in this "Summary of Safety and Effectiveness" document for a K964669 submission.

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To amplify and transmit sound to the ear.

Dahlberg K-AMP BTE

This document is a Summary of Safety and Effectiveness for the Dahlberg K-AMP BTE hearing aid, submitted as part of a 510(k) premarket notification (K964794). This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, the available information is insufficient to address most of your specific questions regarding acceptance criteria and studies proving device performance. The document is a high-level summary and does not contain the detailed study information you are requesting.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

Explanation: The document explicitly states that Dahlberg uses the ANSI S3.22-1987 methodology for testing. For a hearing aid, this standard defines methods for measuring acoustic performance characteristics such as gain, frequency response, distortion, equivalent input noise, etc. The "acceptance criteria" would be compliance with certain thresholds or ranges within this standard, or demonstrating performance comparable to the predicate device according to these measurements. However, the specific numerical acceptance criteria (e.g., "THD must be less than X%") and the actual measured performance data (e.g., "THD was Y%") are not provided in this summary.

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

• Not provided. The summary does not mention any specific clinical or performance studies with test sets, sample sizes, or data provenance. The focus is on demonstrating substantial equivalence through technical characteristics and a comparison to a predicate device.

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. This type of information is typically relevant for diagnostic devices or AI algorithms where expert consensus establishes a "ground truth" for a specific condition. For a hearing aid like this, performance is measured objectively against acoustic standards (like ANSI S3.22-1987) rather than by expert interpretation of images or patient data to establish a ground truth.

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

• Not applicable/Not provided. See explanation for #3.

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 a diagnostic AI system intended to assist human readers. Therefore, an MRMC study is not relevant in this context.

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

• Not applicable/Not provided. This is a hardware device (hearing aid), not a standalone algorithm. Its performance is measured directly by how it amplifies sound.

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

• Objective Acoustic Measurements / Compliance with ANSI S3.22-1987. For a hearing aid, the "ground truth" would be the objective physical characteristics and acoustic performance measurements (e.g., frequency response, maximum output, distortion levels) as defined by the ANSI standard. This is not "expert consensus" in the diagnostic sense, but rather adherence to engineering and performance specifications.

8. The sample size for the training set

• Not applicable/Not provided. Hearing aids are traditionally designed and manufactured based on acoustic engineering principles, not "trained" on data sets in the way AI algorithms are.

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

• Not applicable/Not provided. See explanation for #8.

In summary, the provided document explicitly states that the device's performance data is obtained through the ANSI S3.22-1987 methodology and that it is substantially equivalent to a predicate device (K954941). However, the specific numerical results of these tests and detailed clinical study information are not within this high-level "Summary of Safety and Effectiveness." To find that level of detail, one would typically need to review the full 510(k) submission or associated technical reports, which are not included here.

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