(213 days)
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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AUG - 2 1996
14. 510(k) Summary
| Submitter: | Entlab Oy |
|---|---|
| address | Jaakkolantie 3 |
| city | Hämeenlinna |
| code | FIN 13100 |
| country | Finland |
| phone | +358-17-675-9203 |
- phone +358-17-675-9203 f ax
- Dr. Matti Revonta Contact person: Ultramax Canada Inc. 5571 Sandiford Place V7E 5M5 Richmond, B.C. Canada tel 604-241-1019 fax 604-241-1019
- 18th December 1995 Date
The device:
- Ultramax, an ultrasonic system to assist Trade name in the diagnosis of maxillary and frontal sinusitis
Ultramax Sinus Scanner Common name
Nasal Sinus scanning/measurement device Classification 77LWI name/class
The device to which the equivalence is claimed:
- Echosine 1000 ultrasound system for Trade name scanning sinus cavities
Echosine Sinus Scanner Common name
Nasal Sinus Scanning/measurement device Classification 77LWI name/class
American Electromedics Corp. Manufacturer Sagamore Park Road, Hudson, NH 03051 phone 603-880-6300
Not found 510(k) number
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{1}------------------------------------------------
K 9600044/51 PACE 2 ol 3
| 1 | 2 |
|---|---|
Comparison of the technological characteristics: a summary.
| Ultramax | Echosine | |
|---|---|---|
| Description ofthe method andtarget organs | Ultrasoundsystem to scannasal sinuses | Ultrasoundsystem to scannasal sinuses |
| Targetpopulation | Patients withsuspectedsinusitis | Patients withsuspectedsinusitis |
| Method to detectsinusitis | shows liquidsin the sinuses | shows liquidsin the sinuses |
| Ultrasound mode | pulse-echo | pulse-echo |
| Measuring Range | 0-40 or 0-80mm | 0-30 or 0-80mm |
| Leds/Markerson the display | 2.5 mm or 5 mm | 2 mm steps |
| Image freeze | yes | yes |
| Controls | receiver gaindepth range | receiver gaindepth rangeCRT focus |
| Probe designcontact material | round flatepoxy | roundepoxy |
| Beam | unfocused | focused |
| Probe frequency | 3 MHz | 3.5 MHz |
| Probe diameter | 8 mm | 13 mm |
| Probe area | $50 mm^2$ | $133 mm^2$ |
| Pulse duration | 0.9 us | 0.3- 0.5 us |
| Maximum Ultrasonic Power | 0.9 mW | |
| MI (mean) | 0.0962 | |
| Pulse repetition fr. | 300 Hz fixed | |
| continued: | ||
| Ultramax | Echosine | |
| Display | a bar of lightemitting diodes(LEDs) | cathode raytube (CRT) |
| Echo display mode-low intensity | brightnessof one LED | amplitude of apeak on CRT |
| -high intensity | breadth of theecho complex | breadth of theecho complex |
| Hard copy | Polaroid camera(optional) | printer(optional) |
| Power supply | 9 V rechargeablebattery + 120Vcharging unit | 120V 50-60Hzmains |
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K 9600 44/51 PAGE 3 of 3
Conclusions:
The Ultramax and the Echosine diagnostic ultrasound systems are substantially equivalent.
Description of the device
Indications for use: 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.
Principles of operation: 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.
Power source: Rechargeable 9 V battery. Charging unit with 110 V hospital grade charger.
Composition: Probe, probe cable (optional), extension tube, hand held unit, charging unit, gel bottle (empty), calibration check rod.
Measures: Length 22 centimeters, weight 170 grams. Performance parameters: Maximum values are for MI: 0.1195, Isrn.; 0.230 mW/cm² and Isepx.3 0.956 W/cm². The results are all less than those for diagnostic use, given by the FDA.
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§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.