(4 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.
The Aloka SSD-3500 Ver. 7.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezoelectric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-3500 Ver. 7.0 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The provided text is a 510(k) summary for the Aloka SSD-3500 Ver. 7.0 diagnostic ultrasound system and its transducers. This document confirms the device is substantially equivalent to a predicate device (Aloka SSD-3500 Ver. 1.0) and outlines its intended uses and compliance with relevant standards.
However, the document does not contain specific acceptance criteria, study data, sample sizes for test and training sets, or details about ground truth establishment, expert qualifications, or adjudication methods as typically found in a study demonstrating device performance. It is a regulatory clearance document, not a clinical study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: This information is not present. The document asserts "substantial equivalence" to a predicate device, meaning its performance is considered equivalent, but no specific performance metrics or acceptance criteria for that equivalence are detailed here.
- Sample sizes for the test set and data provenance: No such details are included.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what can be extracted from the document regarding the device and its assessment:
Device: Aloka SSD-3500 Ver. 7.0 Diagnostic Ultrasound System and its associated transducers.
Nature of Assessment: Substantial equivalence (510(k) clearance) to a legally marketed predicate device, the Aloka SSD-3500 Ver. 1.0 (K023996). This means the FDA determined the new device is as safe and effective as the predicate device. The assessment primarily relies on comparing the new device's technological characteristics, indications for use, and compliance with standards to the predicate device.
Key statements of equivalence (from page 4):
- "The Aloka SSD-3500 Ver. 7.0 functions in the same manner as other diagnostic ultrasound devices and its predicate."
- "The Aloka SSD-3500 Ver. 7.0 and its transducers are substantially equivalent to its predicate; the Aloka SSD-3500 Ver. 1.0 and its transducers."
- "The SSD-3500 Ver. 7.0 is indicated for the same diagnostic ultrasound applications to Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996)."
- "The SSD-3500 Ver. 7.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996)."
- "The SSD-3500 Ver. 7.0 uses essentially the same technologies for imaging, Doppler functions and signal processing as the following product currently marketed by Aloka: SSD-3500 Ver. 1.0 - (K023996)."
- "The SSD-3500 Ver. 7.0 has the same method of use as the following products currently marketed by Aloka: SSD-3500 - (K023996)."
- "The SSD-3500 acoustic power output levels are below the maximum levels allowed by the FDA."
- "The SSD-3500 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-3500 -(K023996)."
- "The patient contact materials used in the SSD-3500 Ver. 7.0 have been evaluated for safety via the same standards and methods as the above mentioned products marketed by Aloka. These materials have been found to be safe for the intended uses."
- "The SSD-3500 Ver. 7.0 complies with electrical and physical safety standards as other products currently marketed by Aloka such as its predicate: SSD-3500 - (K023996)."
- "Aloka Co., Ltd. Certifies that the SSD-3500 Ver. 7.0 complies with NEMA-UD2:2004 Rev. 3- (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment), NEMA-UD3: 2004 Rev.2- (Standard for Real Time Display of Thermal & Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment), and IEC-60601-1-2: 2001 - (Medical Electrical Equipment Part 1-2: General requirements for Safety-Collateral standard: Electromagnetic compatibility-Requirements and Tests)."
Transducers and their Indications for Use: The document lists numerous transducers and their cleared clinical applications and modes of operation (e.g., Fetal, Abdominal, Cardiac, Small Organ, Peripheral Vascular, etc., with modes like B, M, PWD, Color Doppler, Amplitude Doppler). These are presented as "previously cleared by FDA" (P) or "new indication" (N). Each indication for use form specifies which modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other) are cleared for various clinical applications for that specific transducer.
Study: The document does not describe a clinical study of the device's performance in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it's a regulatory submission affirming that the device is substantially equivalent to a previously cleared device based on design, intended use, technology, safety, and adherence to performance standards (NEMA-UD2, NEMA-UD3, IEC-60601-1-2). The "study" here is the comparison and certification process to meet regulatory requirements for 510(k) clearance.
§ 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.