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510(k) Data Aggregation
(3 days)
FUKUDA DENSHI MODEL UF-850XTD
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-850XTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-850XTD is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
The Fukuda Denshi model UF-850 XTD is a full featured general purpose Track III diagnostic ultrasound system. The device consist of a mobile console approximately 19" wide, 31"deep and 53-57" (adjustable) high, that provides digital acquisition, processing and display capabilities. The user interface includes a keyboard, specialized controls and either a color CRT or LCD display.
The provided document is limited in the detail required to fill out all requested sections. This is common for 510(k) submissions of the time, especially for devices undergoing modifications or demonstrating substantial equivalence where extensive new clinical studies are not always required.
However, based on the information provided, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria for a new AI/algorithm but rather focuses on comparing the modified device's performance to a predicate device. The core acceptance criterion for this 510(k) modification is substantial equivalence to the predicate device, the Fukuda Denshi model FF sonic UF-750XT Diagnostic Ultrasound System (K033209).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence: Same fundamental technology as predicate device. | The UF-850XTD incorporates the "same fundamental technology as the predicate device." |
| Probe Equivalence: Probes are modified versions of those cleared with the predicate. | "All probes are modified version of the probes cleared with the predicate." |
| Acoustic Output Compliance: Acoustic output remains below pre-amendment upper limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9 for Track 3, Non-ophthalmic). | "The Acoustic Output is measured and calculated per NEMA UD 2... The system will assure that the acoustic output will always stay below the pre-amendment upper limits..." |
| Material Biocompatibility: Patient contact materials are biocompatible and identical to the predicate device. | "All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device." |
| Safety and Efficacy Equivalence: The device is as safe, as effective, and performs as well or better than the predicate device. | "The conclusion drawn from the testing... demonstrates that this device is as safe, as effective and performs as well or better than the current legally marketed predicate device..." |
| Conformity to Applicable Standards: The device adheres to specified medical device safety standards (e.g., NEMA, EN, ISO). | Laboratory testing verified conformity to NEMA UD 2, NEMA/AIUM UD 3, EN 60601-1-1, EN 60601-1-2, EN 60601-1-2-37, ISO 10993, and ISO-14971. |
Study Details
Based on the provided document, no specific clinical study involving AI or an algorithm for diagnostic interpretation was conducted or noted. This submission is for a modification of an ultrasound system, not the clearance of an AI/ML diagnostic tool. The document explicitly states:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No test set for an AI/algorithm was described. The testing described was laboratory-based to verify design specifications and compliance with standards.
- Data Provenance: Not applicable for AI/algorithm performance. The context is system verification against design specifications and predicate device equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for an AI/algorithm test set was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 MRMC study was done. This submission does not pertain to AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This submission is for a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for AI/algorithm performance. The "truth" for this submission was based on engineering design specifications, performance against known physical standards (e.g., acoustic output), and comparison to the predicate device's established performance.
8. The sample size for the training set:
- Not applicable. No training set for an AI/algorithm was described.
9. How the ground truth for the training set was established:
- Not applicable.
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