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Found 13 results
510(k) Data Aggregation
(28 days)
Starkey Laboratories, Inc.
The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.
The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.
Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that can optionally periodically fluctuate in amplitude and frequency to provide relief for patients suffering from tinnitus.
Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid. More specifically, Tinnitus Multiflex is an added branch of code that is separate from the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics (besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid models.
Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-care professional utilizing the Starkey proprietary hearing-aid programming software, Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs or automatically adjusted via the new audiogram shaping functionality.
The provided text describes a 510(k) premarket notification for a Tinnitus Masker device (Multiflex Tinnitus Technology) and does not contain detailed information about a clinical study involving experts, test sets, or ground truth establishment in the context of typical AI/ML device evaluations. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K122876) based on technological characteristics and performance specifications for non-clinical testing.
Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered directly from the provided text as they pertain to clinical evaluations that were explicitly stated as not being performed for this submission.
Here is the information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|
| Max overall output level - 87 dB SPL | Same (Acoustic measurements of output levels, utilizing previously defined limits, were used during verification to ensure that the maximum allowable stimulus level for the subject device was the same as the predicate device. All results passed.) |
| Max A-weighted overall output - 87 dB SPL | Same (Acoustic measurements of output levels... All results passed.) |
| Max 1/3 octave output level – 87 dB SPL | Same (Acoustic measurements of output levels... All results passed.) |
| Maximum output in a 2cc coupler limited to 87 dB SPL | Same (Acoustic measurements of output levels... All results passed.) |
| Tinnitus output levels are set to specified limits by the hearing-care professional. Patient volume/level controls can be enabled to provide adjustments that can decrease or increase output levels within set limits. | Same |
| Power Source: May use any 1.4V hearing-aid battery (size 13, 312 or 10) or be rechargeable. | Same |
| Risk analysis and verification testing to ensure safety and effectiveness. | Risk analyses and verification testing were performed for the addition of the audiogram-shaping functionality. Results demonstrated that Tinnitus Multiflex meets the device testing acceptance criteria described in the predicate submission (K122876) and is substantially equivalent. |
| Addition of audiogram-shaping functionality does not impact safety and effectiveness. | The addition of the audiogram-shaping functionality was assessed by appropriate risk management methodology and addressed with verification and validation testing. The results of the verification and validation testing support that the addition of the audiogram-shaping functionality does not impact safety and effectiveness. |
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. No clinical test set data was reported. The device is a "firmware program code (algorithm)" embedded in a hearing aid, and the testing described is non-clinical (risk analysis, verification, and validation testing for the audiogram-shaping functionality).
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. No clinical expert review for ground truth was reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical adjudication method was reported.
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. No MRMC study was reported. The device is a "Tinnitus Masker" technology, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable in the context of typical AI/ML algorithm-only performance studies. The Multiflex Tinnitus Technology is described as an algorithm embedded in a hearing aid, but its "performance" is primarily related to its ability to generate specific sound characteristics and adjust based on audiograms, rather than an AI-driven diagnostic or interpretative function. The evaluation focuses on meeting predefined acoustic output limits and maintaining safety and effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical testing performed, the "ground truth" consisted of predetermined acoustic specifications and safety/effectiveness criteria for the device's functionality.
8. The sample size for the training set
Not applicable. This document is a 510(k) submission for a non-AI/ML device (firmware for a tinnitus masker) and does not describe a machine learning training process or training set.
9. How the ground truth for the training set was established
Not applicable, as there was no reported machine learning training set.
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(42 days)
STARKEY LABORATORIES
The Multiflex Tinnitus Technology™ is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.
The Multiflex Tinnitus Technology™ is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The ncating patients barrering from themnology™ must be done by a hearing professional participating in a Tinnitus Management Program.
The Starkey Multiflex Tinnitus Technology™ provides the hearing care professional with an option to treat those patients suffering from tinnitus. It is a firmware functionality option embedded in the signal processing stage of a digital hearing aid. The Multiflex Tinnitus Technology™ firmware generates broadband white noise that periodically fluctuates in amplitude and frequency to provide relief for those suffering from timitus.
The Multiflex Tinnitus Technology™ functionalities and parameters are enabled and adjusted by a hearing care professional to meet the individual needs of the patient.
The provided text does not contain detailed information about specific acceptance criteria, study methodologies, or performance results for the Starkey Laboratories Multiflex Tinnitus Technology. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone performance study with detailed acceptance criteria and results.
Here's a breakdown of what can be extracted and what is missing:
The submission states:
"Starkey Laboratories has conducted a risk analysis and performed the necessary verification and validation activities to demonstrate that the design outputs meet the design inputs. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
However, no specific acceptance criteria or quantitative performance data from these verification and validation activities are provided in the extracted text. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given input.
Regarding the other requested information:
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A table of acceptance criteria and the reported device performance: Not available in the provided text. The document only generally states that testing was performed and confirmed the device meets design inputs for its intended use.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text. The 510(k) summary doesn't disclose details about sample sizes or data provenance for any testing.
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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/available. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnoses). Since the device is a tinnitus masker generating sound, the "ground truth" would likely relate to objective sound characteristics or subjective patient feedback, though no details are provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/available. See point 3.
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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 sound generator for tinnitus, not an AI-assisted diagnostic tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a "firmware functionality option embedded in the signal processing stage of a digital hearing aid" that "generates broadband white noise." Its performance as a standalone algorithm would likely involve objective acoustic measurements (e.g., frequency response, amplitude stability, output levels) and potentially subjective patient feedback studies. However, no specific details of such standalone performance studies are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. For a tinnitus masker, ground truth could involve objective acoustic properties of the generated sound, or validated patient-reported outcome measures for tinnitus relief. The document generically mentions "verification and validation activities" but doesn't specify the ground truth used.
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The sample size for the training set: Not applicable/available. This sounds like an AI/machine learning term. While the device has "firmware functionality," the description doesn't suggest it's a machine learning algorithm that requires a "training set" in the typical sense. It seems to be a more deterministic signal generation process.
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How the ground truth for the training set was established: Not applicable/available. See point 8.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, as well as general statements about risk analysis and verification/validation. It explicitly states: "The schedule of use is supported by an FDA consensus standard with amplitude/frequency fluctuation being supported by a number of research studies included in this submission." However, the details of these research studies, their methodologies, acceptance criteria, or quantitative results are not included in the extracted text.
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(243 days)
STARKEY LABORATORIES, INC.
The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Crescent Sound Generator is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus.
The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy.
This document is a 510(k) clearance letter from the FDA for a device called "Crescent Sound Generator." It does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot provide the requested information based on the given text.
The document states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This determination is typically based on comparing the new device to existing ones, rather than requiring the new device to meet specific performance acceptance criteria through a dedicated study as one might see for novel technologies.
The 510(k) process primarily focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness compared to a predicate device. It does not typically involve the detailed performance studies, acceptance criteria, and ground truth establishment associated with AI/ML devices or more innovative medical devices that might require a PMA or de novo clearance.
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(49 days)
STARKEY LABORATORIES, INC.
To obtain an accurate imprint of an individual ear and ear canal.
Precise Impression Kit. Impression Kits, -- Substantially equivalent to the Silhouette™ Premium Impression System from Siemens Hearing Instruments, Inc. and the Matrics Impression System from Matrics, Inc.
The provided text describes a medical device called the "MAY - 2 1997 K970952 PRECISE IMPRESSION KIT." However, it is a 1997 510(k) submission, and the content focuses on establishing substantial equivalence to predicate devices for regulatory approval. This type of submission does not typically include detailed performance studies with acceptance criteria in the manner of modern AI/ML device evaluations.
Therefore, I cannot extract the information required in your request from the provided text. The document is about a basic impression kit and lacks any mention of AI, machine learning, or quantitative performance metrics for a "device" in the context of an AI/ML algorithm.
Here's why and what's missing:
- No AI/ML Component: The "Precise Impression Kit" is a physical product used to take ear impressions. There is no indication of any artificial intelligence or machine learning component.
- Regulatory Standard at the Time: In 1997, 510(k) submissions for devices like this focused on demonstrating substantial equivalence to existing legally marketed devices based on technological characteristics and intended use, not on rigorous statistical performance studies as would be required for a novel diagnostic or AI device today.
- Lack of Performance Metrics: The document lists features like "Smooth consistency, ease of insertion, non-allergenic properties, pleasant scent, quick drying time, easy clean up." These are descriptive characteristics, not quantitative performance metrics with associated acceptance criteria that would be evaluated in a study.
- No "Study" in the Requested Sense: The document describes the device and its intended use but does not present a "study" that proves the device meets acceptance criteria in the way you've outlined.
To answer your request, I would need a different type of document, specifically one that describes a performance study for an AI/ML-enabled medical device.
If you can provide such a document, I would be happy to analyze it against your criteria.
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(103 days)
STARKEY LABORATORIES, INC.
To obtain an accurate imprint of an individual ear and ear canal.
The above mentioned impression kits are designed to provide the tools necessary for a Hearing Health Professional to obtain an accurate imprint of an individual ear and ear canal. The Hearing Health Professional receives materials in the form of a kit, and is responsible for any mixing of materials, or assembly of components for usage.
Analysis of Acceptance Criteria and Device Performance for Precise, Tympanette, and Xacto Impression Kits
Based on the provided documents (SUMMARY and SAFETY AND EFFECTIVENESS SUMMARY), the acceptance criteria and device performance are primarily established through a claim of "substantial equivalence" to existing, commercially available products (Audalin Liquid and Impression Polymer) that were exempt from a 510(k) process due to their pre-1996 commercial distribution.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documents do not detail specific quantitative acceptance criteria or a formal study with measured performance metrics against those criteria. Instead, the "acceptance criteria" are implied by the listed "Features" of the impression kits and the claim that these features are substantially equivalent to the Audalin products.
| Acceptance Criteria (Implied from "Features") | Reported Device Performance (Claimed) |
|---|---|
| Smooth Consistency | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Smooth Consistency." |
| Ease of Insertion | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Ease of Insertion." |
| Non-Allergenic Properties | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Non-Allergenic Properties." |
| Pleasant Scent | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Pleasant Scent." |
| Quick Drying Time | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Quick Drying Time." |
| Ease in Clean Up | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Ease in Clean Up." |
Note: The "Reported Device Performance" here is a direct reiteration of the claimed "substantial equivalence" rather than data from an independent performance study against these criteria. The documents state, "The material in the impression kits are substantially equivalent to Audalin Liquid and Impression Polymer."
Study Details: Substantial Equivalence Claim
The provided text describes a claim of "substantial equivalence" as the primary "study" or justification for meeting acceptance criteria. This is not a study in the traditional sense of a clinical trial or performance evaluation with a test set of data.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. There is no mention of a "test set" of data in the provided documents. The claim relies on the similarity of the new products to established ones.
- Data Provenance: Not applicable. No data or specific studies are described. The foundation is the commercial distribution and properties of the Audalin products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. No ground truth was established by experts for a test set in the context of the provided information.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC comparative effectiveness study was not done. The document focuses on material properties and equivalence, not reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an impression kit, not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used:
- The "ground truth," in this context, is the established characteristics and historical safe and effective use of the predicate devices (Audalin Liquid and Impression Polymer). The new devices are deemed acceptable because their material properties and intended use are considered identical or highly similar to these predicates, which were already commercially distributed and presumably met implicit safety and effectiveness standards. There is no mention of a specific, new "ground truth" being established by pathology, outcomes data, or expert consensus for the new kits themselves beyond this equivalency claim.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, this is not an AI/machine learning device.
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(71 days)
STARKEY LABORATORIES, INC.
The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.
The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system. It includes electronic circuitry, a 4.7" color LCD monitor with 640*480 resolution, a built-in Thermoprinter, a loudspeaker, a 3.5 inch disk drive, a test chamber for hearing aid measurement, a battery simulator, two RS-232 serial port interfaces, and a real ear probe mic. It is controlled by a fully functional PC style keyboard.
The provided document is a summary of the Rastronics portaREM-3000 and Starkey PFS-6000, which are hearing aid calibrator and analysis systems. It describes the device's intended use, features, technical characteristics, and controls. However, it does not contain any information about a study to prove acceptance criteria or any reported device performance data in the format requested.
The document primarily focuses on the device's specifications and capabilities, not on clinical performance or validation studies that would involve acceptance criteria, sample sizes, ground truth establishment, or expert evaluations. It states that "Technical specifications complies to IEC 601 and FCC part 15 class B," but this refers to electrical safety and electromagnetic compatibility standards, not performance metrics related to its intended function as a hearing aid calibrator and analysis system.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
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(45 days)
STARKEY LABORATORIES, INC.
To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
The Starkey TM air conduction high frequency tinnitus maskers are designed to be behind-the-ear maskers. This form of masker is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly. The Starkey TMs are BTE Tinnitus Maskers with a white noise generating circuit which can be tuned to match the frequency and intensity of ringing in the patient's ears (head). The patient has a volume control for this circuit. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies.
Here's an analysis of the provided text regarding the Starkey TM series tinnitus maskers, focusing on acceptance criteria and supporting studies.
Based on the provided document, the device's acceptance criteria are centered on substantial equivalence to a previously cleared device, the masking portion of the Starkey CE-8 TML/TMC (K940667). There isn't a performance study in the traditional sense with metrics like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "study" is a comparison of technical characteristics to establish equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (Starkey TM Series) |
|---|---|---|
| Intended Use | To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears). (Same as predicate) | To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears). |
| Masking Functionality | Generate white noise, adjustable frequency and intensity (volume). (Same as predicate) | White noise generating circuit, tunable to match frequency and intensity, adjustable masker level control, variable low and high frequency cut potentiometers. |
| General Device Type | Tinnitus masker (Same as predicate) | BTE Tinnitus Maskers |
| Components | Made with standard hearing aid parts. (Same as predicate) | Made with standard hearing aid parts. |
| Power Source | Uses standard hearing aid battery (Predicate: 13, Device: 675). | Uses standard hearing aid 675 battery. |
| Technical Characteristics | Comply with ANSI S3.22-1987 (for the masking portion) | Technical specifications comply with ANSI S3.22-1987. |
| Fit (Frequency Response) | Masker frequency response based on patient needs. Tolerances maintained to a ±4 dB range for SSPL. (Implied for masking function) | Masker frequency response varying based on the needs of the patient. Tolerances are maintained to a ±4 dB range for SSPL. |
| Controls | Adjustable volume control; adjustable masker frequency/level (Predicate: adjustable volume, adjustable masker frequency/level). | Adjustable masker level control, variable low and high frequency cut potentiometers (for frequency adjustment). Volume controls similar to other hearing aids. |
| Assembly | Assembled from standard components commonly used in hearing aid devices. (Implied from predicate) | Assembled from standard components that are widely used in hearing aid devices throughout the industry. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this submission. There is no "test set" of patient data or device performance data on a cohort of users. The submission focuses on comparing device specifications.
- Data Provenance: Not applicable. The data provided is a comparison of product features and technical specifications, not clinical trial data derived from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in this case, is the established technical specifications and intended use of the predicate device and the new device. This isn't a subjective assessment requiring expert consensus on individual cases.
- Qualifications: Not applicable.
4. Adjudication Method (for the test set)
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication. The comparison is based on documented device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, this device is a physical medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is the established technical specifications, functional descriptions, and intended use of thepredicate device (Starkey CE-8 TML/TMC, K940667) and the new device (Starkey TM Series). The comparison is fundamentally against these documented characteristics to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant in this context.
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(34 days)
STARKEY LABORATORIES, INC.
To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear.
Custom fit air conduction hearing aids available as ITE, ITC, or CIC -- Substantially equivalent to the Starkey CE-9 Resolution programmable hearing aid, (K933989). Adjustable hearing aid volume control, color coding for left and right instruments, 6 programmable options: Low cut, High cut, Gain control, Compression ratio, Threshold knee, and Output limiting for Sequel, or Loudness Boost for K Amp. Assembled from standard components that are widely used in hearing aid devices throughout the industry. Technical specifications comply with ANSI S3.22-1987. Frequency response varying based on the needs of the patient. Tolerances are maintained to a ± 4 dB range for SSPL and slope, with +6 dB, -4 dB for gain. Volume controls, similar to those used on other hearing aid devices. Switches may be incorporated as options require. Any switches are similar to those used in other hearing aid devices. Standard hearing aid batteries.
This document is a 510(k) summary for a hearing aid, which falls under medical device regulation. The information provided is not about an AI/ML device performing analysis or diagnosis. Therefore, several of the requested categories regarding acceptance criteria for AI algorithms, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.
The "acceptance criteria" in this context refer to the technical specifications and performance characteristics of the hearing aid, and its equivalence to a predicate device.
Here's an attempt to populate the table with the available relevant information, and explain why other fields are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from "Technical Characteristics") | Reported Device Performance (from "FIT" and "Custom Sequel, K Amp Programmable" sections) |
|---|---|
| Technical specifications comply with ANSI S3.22-1987 | (Implicitly Complies, as substantial equivalence is claimed based on these characteristics.) |
| Frequency response varying based on the needs of the patient. | Full range programmability from 100dB SSPL to 117dB SSPL, 20dB gain to 50dB gain. |
| Tolerances maintained to a ± 4 dB range for SSPL and slope. | (Not explicitly stated in the "Reported Device Performance" section, but implied by adherence to ANSI standards and substantial equivalence claim.) |
| Tolerances maintained to +6 dB, -4 dB for gain. | (Not explicitly stated in the "Reported Device Performance" section, but implied by adherence to ANSI standards and substantial equivalence claim.) |
| 6 Programmable Features | 6 Programmable features (Low cut, High cut, Gain control, Compression ratio, Threshold knee, and Output limiting for Sequel, or Loudness Boost for K Amp). |
| Non Volatile Memory | Non Volatile Memory |
| Full range programmability (Predicate: 105dB SSPL to 125dB SSPL, 30dB gain to 60dB gain) | Full range programmability from 100dB SSPL to 117dB SSPL, 20dB gain to 50dB gain |
| Class D output instrument with compression available (Predicate) | Totally programmable class D compression instrument |
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. This submission is for a traditional medical device (hearing aid), not an AI/ML device. Performance is demonstrated through technical specifications and comparison to a predicate device, not through a 'test set' of data in the AI/ML sense.
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. No ground truth established by experts in the context of an AI/ML algorithm's performance. The "ground truth" for a hearing aid's efficacy is its ability to amplify sound appropriately for a patient's hearing loss, which is assessed clinically and through electroacoustic measurements, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for an AI/ML 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
- Not applicable. This is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical hearing aid; there is no 'algorithm only' performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of "Evidence" (instead of ground truth): The "ground truth" for a hearing aid's function is its adherence to technical specifications (e.g., ANSI standards) and its ability to provide acoustic amplification meeting clinical needs. This is typically evaluated through laboratory electroacoustic measurements and clinical fitting. The primary method of demonstration here is substantial equivalence to a legally marketed predicate device (Starkey CE-9 Resolution K933989), meaning its characteristics and intended use are similar enough to the predicate that it raises no new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. No 'training set' in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable. No 'training set' and therefore no ground truth establishment for it.
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(36 days)
STARKEY LABORATORIES, INC.
To assist in compensating for hearing loss by amplifying sound as it comes into the ear.
The Starkey A-13 air conduction hearing aids are designed to be behind-the-ear hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.
The provided text does not describe a study proving the device meets acceptance criteria. Instead, it is a document (K964214 summary) asserting substantial equivalence of the Starkey A-13 Programmable hearing aids to the BOSH Star 42 hearing aid (K942594).
Therefore, I cannot provide the requested information in the format specified.
However, I can extract what might be considered "acceptance criteria" based on the "TECHNICAL CHARACTERISTICS" and "FIT" sections, and how the device "meets" them by referencing adherence to industry standards and general performance descriptions.
Based on the provided text, here's an attempt to categorize the information, but please note that this is an interpretation as a formal study or explicit acceptance criteria with performance against them is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Derived from text) | Reported Device Performance (Derived from text) |
|---|---|---|
| Technical Specifications | Compliance with ANSI S3.22-1987 (Standard for Hearing Aids) | Technical specifications comply with ANSI S3.22-1987. |
| Fit/Tolerances | Frequency response based on patient needs | Frequency response varying based on the needs of the patient. |
| SSPL (Sound-Pressure Level) and Slope Tolerance: ±4 dB | Tolerances are maintained to a ±4 dB range for SSPL and slope. | |
| Gain Tolerance: ±4 dB | Tolerances are maintained to a ±4 dB range for gain. | |
| Intended Use | To assist in compensating for hearing loss by amplifying sound | To assist in compensating for hearing loss by amplifying sound as it comes into the ear. Fits mild to moderate hearing losses (A-13) and moderate to profound (BOSH Star 42, deemed equivalent). |
| Substantial Equivalence | Similar to BOSH Star 42 (K942594) in design and features | Substantially equivalent to the BOSH Star 42 hearing aid. Shares BTE air conduction, adjustable gain, Telephone/Mic/Off Switch. Differences noted (e.g., specific programmable features, battery size, fitting range for A-13 described as "mild to moderate" versus Star 42 "moderate to profound" indicating a range of applicability). |
The remaining requested information (2-9) cannot be provided because the document is a "Summary - Substantial Equivalence" and not a study report.
- There is no study described that involves a test set, ground truth, experts, adjudication, or a multi-reader multi-case comparison.
- The document primarily focuses on comparing the Starkey A-13 with a predicate device (BOSH Star 42) to establish substantial equivalence, meaning it asserts that the new device is as safe and effective as a legally marketed device, rather than providing new performance data from a specific study.
- The mentions of "compliance with ANSI S3.22-1987" and specific tolerances (±4 dB) are statements of design intent and adherence to standards, not results from a specific clinical or technical performance study described within this document.
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(63 days)
STARKEY LABORATORIES, INC.
To generate and transmit a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
Custom fit air conduction Tinnitus Masker
Here's an analysis of the provided text regarding the Starkey TM air conduction tinnitus masker, focusing on the requested acceptance criteria and study information:
Based on the provided text, the "acceptance criteria" appear to be technical specifications and safety standards rather than performance metrics related to the device's efficacy in masking tinnitus. Similarly, there is no detailed "study" described that proves the device meets specific acceptance criteria in terms of its intended use (masking tinnitus).
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Technical/Safety) | Reported Device Performance (as described) |
|---|---|
| Technical specifications | Comply with ANSI S3.22-1987 |
| Frequency response tolerances | Maintained to a ± 4 dB range for SSPL |
| Components | Assembled from standard components widely used in hearing aid devices |
| Controls | Similar to those used on other hearing aid devices (potentiometers or switches similar to those used in other hearing aid devices) |
| Power Source | Standard hearing aid battery (size 13 for ITE, size 312 for ITC) |
| Substantial Equivalence | Substantially equivalent to the Starkey CE-8 TML/TMC, K940667 |
Note: The document describes the device's characteristics and its compliance with technical standards, but it does not provide performance data related to its intended use of masking tinnitus. For example, there are no metrics like "percentage of users experiencing reduced tinnitus" or "average reduction in perceived tinnitus loudness."
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. The provided text does not describe a clinical study or a test set used to evaluate the device's effectiveness in its intended use. The "acceptance criteria" relate to technical specifications and safety, not clinical 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)
- Not applicable. There is no mention of a test set or ground truth establishment based on expert consensus for the device's performance in masking tinnitus. The compliance with ANSI S3.22-1987 implies adherence to established engineering standards, but not a separate expert evaluation of tinnitus masking efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As no test set for clinical performance is described, there is no adjudication method 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
- No. This device is a tinnitus masker, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical efficacy. The "ground truth" implicitly referred to in the context of "Technical specifications comply with ANSI S3.22-1987" is the set of established engineering standards for hearing aids/maskers. This isn't a "ground truth" for clinical outcomes.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
Summary of Findings from the Provided Text:
The document describes the technical specifications and features of the Starkey TM air conduction tinnitus masker and asserts its compliance with ANSI S3.22-1987 and its substantial equivalence to an earlier model (K940667). It details aspects like controls, power, assembly, and fit. However, the document does not contain any information about a clinical study or performance data demonstrating the device's effectiveness in masking tinnitus in a patient population. The "acceptance criteria" mentioned are technical and regulatory in nature, not performance-based efficacy metrics.
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