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510(k) Data Aggregation
(213 days)
ULTRAMAX/MODEL NUMBER A1
Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.
The Ultramax is an A-scan, pulseecho device, equipped with a single unfocused flat 8 mm 3 MHz transducer. Pulse repetition rate is fixed at 300 Hz. The only controls on the device are the receiver gain, and the range that can be selected between "8" (0-8 cm), " 4 " (0-4 cm) and "4E" (4-8 cm). These selections do not effect the emitted acoustic power.
Here's an analysis of the provided text regarding the Ultramax device, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary (specifically from 1996), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed acceptance criteria and performance metrics against a pre-defined ground truth in the way a modern medical device submission might. Therefore, some requested information may not be explicitly present or will be inferred from the context of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for substantial equivalence in 1996, explicit "acceptance criteria" in terms of specific performance thresholds (e.g., sensitivity, specificity) against a clinical ground truth are not provided in this document. The "acceptance criteria" for a 510(k) submission primarily revolve around safety and effectiveness comparable to a predicate device.
The document discusses "Performance parameters" related to acoustic output for safety, not clinical efficacy.
| Acceptance Criterion (Inferred from 510(k) process) | Reported Device Performance (Ultramax) |
|---|---|
| Technological Characteristics Equivalence | Most characteristics (method, target organs, population, detection method, ultrasound mode, controls, etc.) are stated to be similar or equivalent to the Echosine 1000. Specific differences are noted in the table. |
| Acoustic Output Safety Limits | MI (mean): 0.0962 |
| Maximum MI: 0.1195 | |
| Isata: 0.230 mW/cm² | |
| Isepm.3: 0.956 W/cm² | |
| Outcome: "The results are all less than those for diagnostic use, given by the FDA." | |
| Indications for Use Equivalence | "intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity." (Matches Echosine's implied indication) |
| Principles of Operation Equivalence | A-scan, pulse-echo device, 3 MHz transducer, fixed 300 Hz PRR. |
| Overall Equivalence Conclusion | "The Ultramax and the Echosine diagnostic ultrasound systems are substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical test set for performance evaluation. It is a technological comparison for substantial equivalence. Therefore, there is no mention of sample size or data provenance (country, retrospective/prospective) for a clinical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no described clinical test set, there is no information on experts establishing ground truth.
4. Adjudication Method for the Test Set
Since no clinical test set is described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not described in this 510(k) summary. The document focuses on demonstrating technological and functional equivalence between the Ultramax and the Echosine.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The Ultramax is an ultrasonic device that "assists the physician in the diagnosis." This explicitly indicates a human-in-the-loop scenario. The document does not describe any standalone "algorithm only" performance evaluation, as it's a hardware device with an output display for human interpretation.
7. The Type of Ground Truth Used
No specific type of clinical ground truth (e.g., pathology, clinical outcomes, expert consensus on imaging) is mentioned or implied for performance evaluation of the Ultramax. The evaluation presented is primarily a comparison of technical specifications and intended use against a predicate device for regulatory purposes.
8. The Sample Size for the Training Set
The document does not describe a training set in the context of machine learning or algorithm development. The Ultramax is a traditional ultrasound device, not an AI/ML-driven diagnostic system in the modern sense.
9. How the Ground Truth for the Training Set was Established
Since no training set is described, there is no information on how its ground truth would have been established.
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