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510(k) Data Aggregation
(266 days)
OSRAM SYLVANIA, INC.
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.
| Acceptance Criterion (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Equivalent Intended Use and Indications for Use | OSRAM ITOS O-03100 has the same intended use and indications for use as the predicate (illumination of ear canal and tympanic membrane for observation, OTC use). |
| Equivalent Performance (Bench Testing Critical Parameters) | Bench testing results for key performance parameters demonstrated equivalent performance with respect to parameters critical to safety and effectiveness compared to the predicate otoscope lamp. (Specific parameters are not enumerated, but the broad claim of equivalence is made.) |
| Durability (Robustness to Real-world Applications) | Drop tests (lamp alone, otoscope system) and a pull test of the outer sleeve from the heat sink. Results substantiate that the device is robust to real-world applications. (Specific quantitative thresholds for "robust" are not provided, only that the tests were performed and results were satisfactory). |
| Photobiological Safety (Blue Light Hazard) | Evaluated against IEC 62471:2006-07 Ed. 1. Result: "EXEMPT group" for the ITOS O-03100 LED. (Meaning it poses no photobiological hazard under standard use conditions). |
| Light Hazard Protection (Inadvertent Ophthalmoscope Use) | Tested in ophthalmoscope heads according to ISO 15004-2. Result: OSRAM ITOS O-03100 LED lamp classified as "group 2" per ISO 15004-2. Measured values in all 3 ophthalmoscope heads were below allowable limits for weighted corneal/lenticular UV radiation, unweighted corneal/lenticular UV radiation, unweighted corneal/lenticular IR radiation, and weighted retinal visible/IR radiation thermal radiance. Time-integrated radiance resulted in exposure time limits of ~3 minutes (for 11710 and 11720 heads) and 9 minutes (for 11810 head). This led to a cautionary label. |
| Clinical Equivalence (No Misdiagnoses due to Light) | A clinical study found "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 LED lamp versus the predicate tungsten-halogen lamp. This indicates effectiveness and lack of negative impact on diagnosis. (Specific quantitative acceptance criteria for "clinically meaningful differences" are not provided). |
| Product Integrity (Shipping) | OSRAM Sylvania will conduct testing to ASTM 4169 (Performance Testing of Shipping Containers and Systems) according to Assurance Level I and Criterion 1 and will assure conformance prior to commercial distribution. (This is a future commitment, not a past result at the time of submission, but indicates the benchmark for acceptance). |
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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