(14 days)
The APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.
The APLIO Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
This 510(k) submission for the Toshiba SSA-700A, APLIO Diagnostic Ultrasound System and its associated transducers focuses on substantial equivalence to predicate devices rather than establishing new performance criteria through clinical studies. Therefore, much of the requested information about acceptance criteria and clinical study details (like sample sizes, ground truth establishment, expert qualifications, and MRMC studies) is not present.
However, based on the provided document, here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) from a clinical study. Instead, the acceptance criterion for this 510(k) submission is Substantial Equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that the device performs equivalently to these predicates for the indicated uses.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantially equivalent in safety and effectiveness to predicate ultrasound systems (UIDM-400A (K992886) and SSA-770A APLIO (K013633)). | The APLIO Ultrasound System is considered substantially equivalent to the UIDM-400A (K992886) and SSA-770A APLIO (K013633) for its specified clinical applications and modes of operation. Engineering assessments identified no unmitigated issues of risk or safety compared to the Toshiba SSA-770A Aplio. |
| Compliance with relevant safety and performance standards (e.g., Quality System Regulation, IEC 60601, AIUM-NEMA UD2, AIUM-NEMA UD3). | The device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601 (applicable portions), IEC60601-2-37 (applicable portions), the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems, and the AIUM-NEMA UD3 Output Display Standard. |
| Ability to perform specified clinical applications with various modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Harmonic Imaging). | The device, with its various transducers, supports a wide range of clinical applications including fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (conventional and superficial), and laparoscopic, across various imaging modes (as detailed in the "Indications for Use Form" for each transducer). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" in the context of a performance study with patient data. The basis for substantial equivalence is primarily through engineering assessments and comparison to existing, legally marketed devices. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set requiring ground truth establishment is described, this information is not available in the document.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned in the document. The submission relies on substantial equivalence to predicate devices rather than demonstrating comparative effectiveness with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This device is a diagnostic ultrasound system intended for use by a human operator, not a standalone AI algorithm. Therefore, no standalone algorithm performance study is described.
7. Type of Ground Truth Used:
Not applicable as there is no mention of a primary clinical study requiring ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the identified predicate devices, as demonstrated through their prior clearance and market history.
8. Sample Size for the Training Set:
The document does not describe the use of a "training set" in the context of an algorithm or AI development. This is a traditional medical device submission for an ultrasound system, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is described.
§ 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.