Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope, and others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG , VS Flow, Color M and DICOM).
The SIUI Apogee 2100/ Apogee 2300 is a Digital Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM). The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
Here's a breakdown of the acceptance criteria and study information, based on the provided text, with a crucial caveat: The document describes a 510(k) submission for an ultrasound imaging system, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the types of studies you've listed (e.g., MRMC, standalone AI performance).
Therefore, many of your requested points about clinical studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, and adjudication methods are not present in this type of regulatory document because they are not typically required for a 510(k) clearance of an ultrasound imaging system. The information provided heavily emphasizes hardware and software feature equivalence and safety standards.
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or reader agreement. Instead, the acceptance criteria for this 510(k) submission are implied through demonstrating substantial equivalence to predicate devices in terms of:
- Indications for Use: The new device's intended clinical applications must be substantially equivalent to or within the scope of the predicate devices.
- Technological Characteristics: The new device's core technology, operating modes, and transducers must be substantially equivalent.
- Safety and Effectiveness: Compliance with recognized medical device safety standards and acoustic output limits substituted for direct clinical evidence of safety and effectiveness for a new device.
Table of Acceptance Criteria and Reported Device Performance (as implied by the 510(k) process):
| Acceptance Criterion (Implied for 510(k) Clearance) | Reported Device Performance (Summary from Document) |
|---|---|
| 1. Indications for Use Equivalence | - Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications. |
- Operating Modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM).
- Comparison to Predicate: "All the Indications for Use of the Apogee 2100/ Apogee 2300 are included in the indications for use of predicate SIUI Apogee 1200." and "The Apogee 2100/ Apogee 2300 have three more imaging functions than the predicate SIUI Apogee 5500, namely VS Flow, Color M and DICOM." Additional new configurable transducers (L10LN, C6LN, U5LN) and 5 additional exams (Neonatal Cephalic, Trans-vaginal and Trans-rectal, Gynecology and Urology) are identical to Apogee 5500. |
| 2. Technological Characteristics Equivalence | - Apogee 2100/2300 vs. Apogee 1200: "mainly have cosmetic changes," "same in their working principle and internal modules," "use the same PC module, digital signal processing module, and ultrasound front-end module." Control panel and display adjusted for ergonomics. - Apogee 2100/2300 vs. Apogee 5500: "similar imaging modes," "similar diagnostic ultrasound applications," "similar technical parameters and hardware implementation principle" for transducers. |
| 3. Safety (Acoustic Output & General Safety Standards Compliance) | - Tested per FDA Guidance (Sept 2008) for Diagnostic Ultrasound Systems and Transducers. - Acoustic output measured and calculated per NEMA UD 2:2004.
- Conforms to IEC 60601-1, ISO10993-5, ISO 10993-10, and IEC 60601-1-2. |
Study Information (Based on the 510(k) document):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/not provided. This document describes a 510(k) submission based on technical and performance equivalence and safety standards, not a clinical study with a specific test set of patient data with ground truth.
- Data Provenance: Not applicable/not provided for a clinical test set. The submission relies on engineering tests, compliance with standards, and comparison to existing cleared devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by clinical experts is described for a test set of patient data.
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Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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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. An MRMC study was not done, as this is an ultrasound imaging system regulatory submission, not an AI diagnostic algorithm for which such studies are commonly required. The device itself is the imaging system, not an AI feature providing interpretive assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is inherent to its imaging capabilities, which are assessed against technical specifications and predicate device equivalence.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. The "ground truth" in this context is adherence to engineering specifications, safety standards, and functional equivalence to predicate devices, verified through technical testing.
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The sample size for the training set:
- Not applicable. There is no mention of an algorithm being trained on a dataset.
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How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.
In summary: The provided document is a 510(k) premarket notification for an ultrasound imaging system. The "study" referenced is largely a technical and engineering comparison study to predicate devices and a compliance assessment against recognized safety and performance standards. It does not involve a clinical study with patients, expert readers, or AI performance metrics as would be seen for a diagnostic AI device submission.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.