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AIO HD otoscope is used to provide images of the ear canal and tympanic membrane. The AIO HD otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.

AIO camera system consists of the camera hand probe, main storage unit and otoscope tip. The camera hand probe dimensions are 45 mm (w) x 60 mm (l) x 151 mm (h). The main unit dimensions are 235 mm (w) x 225 mm (l) x 58 mm (h). The otoscope tip is carefully inserted into the external ear to view the ear canal and ear drum.

The provided document is a 510(k) summary for the 'AIO HD Otoscope'. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and safety features, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical or analytical performance study required for higher-risk devices or novel technologies.

Here's a breakdown based on the information provided, and where information is not provided due to the nature of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary for this Class I device primarily compares characteristics to a predicate, rather than setting and meeting formal clinical acceptance criteria with statistical measures. The 'acceptance' here is demonstrated by showing the AIO HD Otoscope's characteristics are comparable to the predicate device, the Dr.Camscope.

Explanation of "Acceptance": For a Class I device seeking 510(k) clearance, "acceptance criteria" often revolve around demonstrating that the new device does not raise new questions of safety and effectiveness compared to a predicate device. In this case, the AIO HD Otoscope is "accepted" if its performance characteristics (like light intensity, temperature, electrical specs) are shown to be equivalent or superior to the predicate, and it functions as intended without introducing new risks. The reported performance shows the AIO HD Otoscope provides significantly higher illumination and operates at a lower temperature than the predicate device, which would be considered favorable for safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a formal "test set" in the context of a performance study involving patient data or clinical outcomes. This submission focuses on engineering and basic performance specifications (light intensity, temperature, electrical, physical dimensions). Therefore, there is:

• No reported sample size for a test set.
• No data provenance (e.g., country of origin, retrospective/prospective) because this type of data is not applicable to the technical specification comparison presented.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since there was no "test set" involving clinical data or human diagnoses, there were:

• No experts used to establish ground truth.
• No qualifications for such experts provided or needed for this type of submission.

4. Adjudication Method for the Test Set

As there was no clinical "test set" requiring human interpretation or diagnosis, there was no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a technical specification comparison, not a clinical effectiveness study. The device is an otoscope which provides images for human interpretation, and this 510(k) does not address AI assistance or changes in human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

A standalone algorithm performance study was not done. The AIO HD Otoscope is a device for capturing images, not an AI algorithm for interpreting them.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured technical specifications of the device itself (e.g., light intensity in lux, temperature in Celsius, voltage, physical dimensions). It is based on engineering measurements, not clinical outcomes, pathology, or expert consensus on clinical data.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for AI/ML algorithms. This device is a medical imaging device (otoscope), not an AI/ML product. Therefore, there is no training set in the AI/ML sense. The "training" for this device would be its design and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

As there is no AI/ML training set, this question is not applicable. The 'ground truth' for the device's design and manufacturing is based on established engineering principles, regulatory standards for medical devices, and performance benchmarks set by predicate devices.

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The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

• . provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;
• includes an expanding membrane that can be inserted and conforms to the external ear . canal when filled with an absorbing medium which enables the 3D scan and;
• records and presents to the hearing professional in an image file a topology measurement . of the external ear canal

The device consists of a hand held scanner, a single patient use disposable with a silicone conforming membrane, which when in use is filled with an absorbing medium, and a laptop computer. The hand held scanner, when not in use, is placed in a docking stand.

The hand held scanner is tethered to the docking stand with a custom cable. The laptop computer is mounted on the docking stand. The hand held scanner contains LED illumination, optics, a camera, a motor to move the probe tip, and a motor-driven reservoir.

User Interface (UI) software screens are displayed on the laptop and the user interacts with the device via the laptop keyboard and touchpad, and control buttons on the hand held scanner, as guided by the UI screens. Image data from the patient is stored in the laptop, and may be transmitted by the user via a wireless connection. No patient identifiable data is stored in the Lantos device.

A single use disposable, which includes the conforming membrane, is placed over the hand held scanner probe tip, in a manner similar to placing an ear speculum over the viewing tip of a conventional otoscope. The disposable includes a clear window over the probe tip. The probe can be used to inspect the ear canal, when inserted into the ear canal no closer than 4-5 mm from the tympanic membrane.

Additionally, the disposable can be filled with an absorbing medium so the membrane conforms to the ear, to enable the 3D scanning functionality of the device. After scanning is complete, the absorbing medium drains from the disposable so that the probe and disposable can be removed from the ear canal. The topographical measurement (scan) of the ear may be transmitted and may be used in the same manner as a desktop scan of a silicone earmold impression.

The provided text describes the Lantos 3D Ear Scanner and its regulatory submission (K121326). However, the document does not contain explicit acceptance criteria or a dedicated study section detailing performance against such criteria for AI/algorithm-driven features.

Instead, the performance evaluation focuses on the accuracy and safety of the 3D scanning functionality and general device characteristics.

Here's an attempt to extract relevant information and note what is missing based on your request:

Acceptance Criteria and Study for the Lantos 3D Ear Scanner

The Lantos 3D Ear Scanner is primarily described as an imaging and 3D measurement device for the ear canal. The provided document focuses on its technological characteristics, safety, and substantial equivalence to a predicate otoscope. It does not present an AI algorithm performance against specific diagnostic acceptance criteria.

The closest information related to performance evaluation concerns the accuracy of its 3D measurement capability.

1. Table of Acceptance Criteria and Reported Device Performance

The method involved validating the output "using two known models (cylindrical and anatomical) with given values and obtaining multiple scans on each using multiple Scanner units." (Specific numerical results of the mean difference are not provided in this document.) |
| Photobiological Safety | Within ACGIH Threshold Limit Values for retinal thermal exposure, blue light exposure, actinic ultraviolet radiation, and near UV exposure. Risk Group 1 classification for blue-violet LED. | The Scanner falls within ACGIH Threshold Limit Values for retinal thermal exposure (within 10 seconds), blue light exposure (within 10,000 seconds), actinic ultraviolet radiation (within 8 hours), and near UV exposure.

Evaluated according to ANSI/IESNA RP-27.3-2007, resulting in a "Risk Group 1" classification for the blue-violet LED. Exposure time limit for Risk Group 1 was 15 minutes of direct, continuous exposure without membrane. |
| Biocompatibility | Conformance to ISO 10993 Parts 1-13 as applicable. | The device "meets the following Recognized Performance Standards: ISO 10993 Parts 1-13 as applicable." |
| Electrical Safety & EMC | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18. | The device "meets the following Recognized Performance Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18." |
| Quality/Risk Management System | Conformance to ISO 14971. | The device "meets the following Recognized Performance Standards: ISO 14971." |

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

• Test Set (for 3D Measurement Accuracy): The document states validation was performed "using two known models (cylindrical and anatomical)" and "obtaining multiple scans on each using multiple Scanner units."
  • Sample Size:
    • Number of models: 2 (cylindrical and anatomical)
    • Number of scanners: "multiple Scanner units" (specific number not given)
    • Number of scans per model/scanner: "multiple scans on each" (specific number not given)
  • Data Provenance: Not applicable as it uses physical models rather than patient data. No country of origin is specified for these models or the testing activities. It is an internal validation rather than a retrospective or prospective patient study.

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

• For the 3D measurement accuracy, the ground truth was established by the "known models (cylindrical and anatomical) with given values." This implies a physical, engineered ground truth rather than expert assessment.
• No experts were mentioned for establishing ground truth for the 3D measurement accuracy test.

4. Adjudication method for the test set

• Not applicable as the ground truth was based on measurements from known physical models, not on human interpretation or consensus.

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, an MRMC comparative effectiveness study was not done. The document describes a device for producing visual images and 3D topographical measurements, not an AI-assisted diagnostic tool that would improve human reader performance. Its core function is to provide data, not to interpret it in an AI-driven manner for a human.

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

• The document describes the performance of the "Lantos 3D Ear Scanner" system, which includes hardware (scanner, disposable, laptop) and software. The "3D scan" is a direct output of the device's optical and mechanical system.
• While an algorithm processes the raw scan data to create the "topology measurement," this is presented as an inherent function of the device itself, not as an AI-driven standalone diagnostic algorithm whose performance needs to be assessed independently against human interpretation in a clinical context. The "algorithm" here is for data processing to generate the 3D model, not for diagnostic interpretation.
• Therefore, a standalone AI diagnostic algorithm performance study, as typically understood for AI medical devices, was not performed, nor is it applicable to the description of this device's reported functionality.

7. The type of ground truth used

• For the 3D topographical measurement, the ground truth was based on measurements from known physical models (cylindrical and anatomical models with given values).
• For safety aspects (photobiological, electrical, biocompatibility), ground truth was established by recognized industry standards (e.g., ACGIH, ANSI/IESNA, ISO, IEC).

8. The sample size for the training set

• The document does not mention a training set. This device, as described, generates a 3D digital model from optical scanning. It's not explicitly presented as an AI/machine learning model that learns from a dataset. The "ground truth" for its measurement accuracy is physical models, not a dataset it was trained on.

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

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

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The OSRAM ITOS O-03100 is intended to provide illumination of the ear canal and tympanic membrane for observation. It is intended for over-the-counter (OTC) use.

The OSRAM ITOS O-03100 is an optional accessory lamp for use in compatible Welch Allyn otoscopes (Models 20000, 20200, 21700, 25020). The OSRAM ITOS O-03100 utilizes light emitting diode (LED) technology.

Here's an analysis of the provided text regarding the OSRAM ITOS O-03100, focusing on acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It primarily details general information, indications for use, device description, and performance data from bench tests and some limited clinical evaluation. It is not a detailed report of a clinical trial designed to establish specific performance metrics against pre-defined acceptance criteria in the way one might expect for a novel high-risk device. Therefore, some requested information may not be explicitly present or may be inferred from the context of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for an accessory lamp that demonstrates substantial equivalence, the "acceptance criteria" are not framed as quantitative statistical thresholds for sensitivity, specificity, or similar clinical performance metrics. Instead, they are related to equivalence with the predicate device and safety standards. The "device performance" is presented as evidence of this equivalence and safety compliance.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes a "clinical study," which serves as the "test set" for assessing clinical equivalence.

• Sample Size: Not explicitly stated. The text only mentions "clinicians" and "diagnoses." It does not provide the number of patients, cases, or clinicians involved in the study.
• Data Provenance: Not explicitly stated whether it was retrospective or prospective, nor the country of origin. However, given that it's a study for a 510(k) submission to the FDA, it is generally assumed to be a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the text.
The clinical study focused on "clinicians' perceptions" and "diagnoses obtained," suggesting that the clinicians themselves were the "experts" whose judgment was being compared between the two lamps. There is no mention of a separate group of experts establishing an independent "ground truth" for the cases presented in this specific clinical study.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated.
Since the study compared "clinicians' perceptions" and "diagnoses obtained" with two different lamps, it likely involved clinicians evaluating cases. Without further details, it's impossible to determine if there was a consensus or a majority-rule adjudication method among multiple clinicians for each case, or if individual clinician evaluations were merely compared.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This was not a typical MRMC comparative effectiveness study in the sense of measuring improvement in diagnostic accuracy with AI assistance. Instead, it was a comparative study between a new technology (LED lamp) and a predicate technology (halogen lamp) to determine if the new technology introduced no clinically meaningful differences in diagnostic performance.

• The text states: "There were no clinically meaningful differences in clinicians' perceptions of the topography of the ear drum and ear canal or in the diagnoses obtained with the ITOS O -03100 lamp and the predicate tungsten-halogen lamp."
• Effect Size: No quantitative effect size (e.g., how much human readers improve with AI vs. without AI) is provided as this was not the purpose of the study. The study aimed to show non-inferiority or equivalence rather than improvement.

6. If a Standalone (Algorithm Only) Performance Study Was Done

This question is not applicable as the device is an accessory lamp, not an algorithm or an AI system itself. Its performance is tied directly to human use.

7. The Type of Ground Truth Used

For the clinical study:

• The "ground truth" was implicitly established by the clinicians' "diagnoses obtained" and "perceptions" while using either lamp. The study aimed to show that the use of the new LED lamp did not alter these diagnoses or perceptions in a clinically meaningful way compared to the predicate. There's no mention of an independent, objective "pathology" or "outcomes data" ground truth against which the clinicians' diagnoses were compared.

8. The Sample Size for the Training Set

This question is not applicable. The device is an accessory lamp and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

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