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510(k) Data Aggregation
(34 days)
The SpeqT is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, and Small Organ. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, and small organ imaging.
The SpeqT can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.
The Signostics Ltd SpecT system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, on an off-the-shelf display. Automated bladder volume measurements are supported.
The provided text lacks specific "acceptance criteria" in a table format and a detailed study proving the device meets these criteria in the way typically expected for a detailed clinical study with human readers and AI assistance. However, it does contain information related to the device's substantial equivalence to predicate devices based on non-clinical performance data, bench testing, and comparisons of intended use.
Based on the provided text, here's an attempt to extract and infer the closest information to your request:
Key Takeaway from the Document:
The document is a 510(k) premarket notification letter from the FDA, stating that the SpeqT device is substantially equivalent to legally marketed predicate devices. The "study" proving this largely relies on bench testing, compliance with standards, and comparison of technical specifications and intended uses rather than a multi-reader, multi-case clinical study for AI validation. The device is a diagnostic ultrasound system, not an AI-powered diagnostic tool requiring the specific AI-related criteria you've outlined. The "acceptance criteria" are implied by the performance of the predicate devices and the compliance with relevant medical device standards.
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Basis)
The document doesn't explicitly define "acceptance criteria" with numerical thresholds in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is gauged by comparison and compliance with standards.
Table 1: Inferred "Acceptance Criteria" and Reported Device Performance
| Category / "Acceptance Criteria" (Inferred) | Reported Device Performance and Basis for Claim |
|---|---|
| 1. Imaging Performance (General Ultrasound): Substantially equivalent B-mode imaging performance to predicate general ultrasound systems (SpeqRT, Speq, Philips Lumify). | "The new SpeqT has been bench tested for imaging performance and measurement accuracy, with tests showing the SpeqT imaging performance and measurement accuracy to be substantially equivalent to the SpeqRT and Speq predicate devices." (Page 9) |
| 2. Bladder Volume Measurement Accuracy: Performance in automatic bladder volume measurement equivalent or better than predicate bladder scanner (Verathon BVI 9400). | "The second part of the intended use statement [bladder volume measurement] is substantially equivalent to the Verathon BVI 9400 system, and internal clinical performance testing comparing the SpeqT and Verathon BVI 9400 shows the SpeqT to be equivalent or better performance than the Verathon BVI 9400." (Page 8) |
| 3. Acoustic Output: Maintain MI and TI < 1.0 (as seen in predicate devices). | SpeqT: Max MI = 0.823, Max TIS = 0.0903. "Both systems [SpeqT and SignosRT] contain sector transducers with annular (circular) acoustic elements... and both maintain MI and TI to be <1.0 at all times." (Page 7) This implies meeting or bettering predicate device acoustic output characteristics. |
| 4. Safety Standards Compliance: Compliance with relevant IEC and ISO standards for medical devices, particularly for ultrasound systems and software. | Complies with: IEC 60601-1:2005, ES60601-1:2005, EN 60601-1:2006, IEC 60601-2-37:2007, IEC 60601-1-2:2007, ISO 10993-1:2009, ISO-10993-5:2009, ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007, NEMA UD-2-2004 (R2009), NEMA UD-3-2004(R2009). Software/firmware verified according to IEC 62304:2006. (Page 9) |
| 5. Risk Management: Device is safe for intended use and does not pose unacceptable risks (per ISO 14971). | "Signostics Ltd applied ISO-14971 to the design and development of the SpeqT. The conclusion from the risk analysis was the device was safe for its intended use and does not pose any unacceptable risks." (Page 6) |
| 6. Biocompatibility: Materials in patient contact are safe. | Implied by compliance with ISO 10993 standards (e.g., ISO 10993-1, -5, -10, -12), which address biocompatibility, cytotoxicity, irritation, and sensitization. |
| 7. Software/Firmware Functionality: Operates as intended; risks mitigated in firmware verified. | "The software and firmware in the SpeqT has been developed and verified according to IEC 62304:2006. The verification report (Appendix R), traceability (Appendix Q), and risk analysis (Appendix A) demonstrate the SpeqT operates as intended and risks mitigated in firmware have been verified." (Page 9) |
Study Details (Based on available information)
1. Sample Sized used for the test set and the data provenance:
- Test Set:
- For imaging performance and measurement accuracy (general ultrasound): The document states "bench tested," implying phantom studies and potentially comparison against image outputs from predicate devices. No specific "sample size" of images or patients for this bench testing is provided.
- For bladder volume measurement: "internal clinical performance testing comparing the SpeqT and Verathon BVI 9400" was conducted. No specific sample size (number of patients or measurements) is given for this clinical testing.
- Data Provenance: Not specified, but "internal clinical performance testing" suggests it was likely proprietary data collected by the manufacturer. No country of origin is mentioned. It's implicitly prospective as it was testing the new device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided because the "testing" described is primarily bench testing (for general imaging) and comparative clinical performance against a predicate device (for bladder volume). It does not appear to involve a human expert-based interpretation ground truth as would be needed for an AI diagnostic algorithm validation. The "ground truth" for the bladder volume measurement would likely be established by a reference method for bladder volume (e.g., catheterization as a gold standard, or a highly accurate existing device), assuming it was a rigorous clinical comparison.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as the described studies are not based on human expert review and adjudication for establishing ground truth in the context of an AI diagnostic model.
4. 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 evidence of an MRMC study. The device is a diagnostic ultrasound system (hardware and software for image acquisition and basic measurements like bladder volume), not an AI-assisted diagnostic tool that interprets complex medical images for human readers. Therefore, this type of study is not relevant to the described premarket notification.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of bladder volume measurement. The device "automatically determine[s] bladder volume." The "internal clinical performance testing comparing the SpeqT and Verathon BVI 9400" would assess this standalone automatic measurement against a reference without human interpretation in the loop. For the general imaging, the device produces B-mode images, which are then interpreted by a trained user, so the "standalone" performance here relates to the image quality it produces, not an automated diagnostic output beyond the bladder volume.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For general imaging performance: Likely quantitative metrics from phantom studies (e.g., resolution, penetration, contrast) and visual comparison of image quality against predicate devices, which wouldn't involve an "expert consensus" in the diagnostic sense.
- For bladder volume measurement: The ground truth for this "internal clinical performance testing" would likely be a highly accurate reference method for bladder volume, such as catheterization or another validated measurement technique, against which both the SpeqT and the predicate Verathon BVI 9400 were compared.
7. The sample size for the training set:
- Not applicable / Not specified. The document describes a traditional diagnostic ultrasound device, not an AI/machine learning product that requires a "training set" in the context of deep learning models. The software and firmware are developed and verified according to traditional software engineering standards (IEC 62304).
8. How the ground truth for the training set was established:
- Not applicable. As the device is not an AI/ML product with a "training set," this question does not apply.
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