(8 days)
The TERASON™ Model 2000/BAS Portable Ultrasound Systems are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
Technical specifications for the TERASON™ Model 2000/BAS Portable Ultrasound Systems are as follows:
System: Transducer frequencies: 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, 8L4), Frame rate: 15 - 58 fps (Imaging only), Ultrasound lines/frame: 128, Fields of View: 2.5 - 24 cm, External Video Output: Composite Video, VGA Monitor, Liquid-Crystal Display: 10.4" XVGA TFT, Size: Width: 11.6", Height: 9.3", Depth: 1.65", Weight: Laptop Computer 4.84 lb., Smart Probe 10 oz.
Electrical: External Power: Input: 115-250 VAC, Output: 19 VDC @ 4A, Battery: Li-Ion battery pack (4 cells), Leakage Current: 50 μΑ maximum, Primary Breakdown Voltage: greater than 1500 V AC, Safety Standards: IEC 601-1, UL 2601 Can/CSA C22.2 601.1, Protection Class: Class I: per IEC 601-1, Degree of Protection: Type BF: per IEC 601-1.
Environmental: Mechanical Shock: EC 68-2-27 compliant (Smart Probe only), Mechanical Vibration: Sinusoidal: IEC 68-2-6 (Smart Probe only), Drop Test (to concrete): 3 feet (Smart Probe only), Operating Temperature: 0 to 50 C (Smart Probe only), Humidity: 20 to 80% RH, non-condensing, Water Resistance: Transducer array watertight to the strain relief, Altitude (Pressure): 63 Kpa to 101.3 Kpa.
Storage: Temperature: -25 to 60°C (Smart Probe only), -40 to 70°C (GETAC CA25), Humidity: 15 to 98% RH, non-condensing (Smart Probe only).
Refer to computer manufacturer's documentation for relevant environmental specifications.
The provided text for KD030191 is a 510(k) Summary for the TERASON™ Model 2000/BAS Portable Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to predicate devices.
However, this document does not contain the type of detailed information typically found in a study proving a device meets specific performance acceptance criteria, especially for AI/algorithm-driven devices. This document is from 2003, predating the widespread use and regulatory requirements for AI in medical devices as we understand them today.
The document focuses on establishing substantial equivalence based on:
- Intended Use: The TERASON™ 2000/BAS is intended for diagnostic ultrasound imaging or fluid flow analysis, for various clinical applications.
- Technological Characteristics: It lists technical specifications such as transducer frequencies, frame rate, resolution, physical dimensions, electrical and environmental characteristics.
- Comparison to Predicate Devices: It states that the device is substantially equivalent to previously cleared ultrasound systems (Teratech TERASON™ 2000, ATL HDI™ 1500, Dymax Site-Rite 3) because its intended uses and modes of operation are a subset of those predicates.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies, as these aspects are not present in the provided 510(k) summary.
The primary "acceptance criterion" demonstrated in this submission is substantial equivalence to legally marketed predicate devices, as assessed by the FDA based on the provided technical specifications and intended uses, rather than a performance study against predefined benchmarks.
The closest information related to "performance" would be the technical specifications listed, which are descriptive rather than performance metrics with acceptance limits.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose)
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Technical Specifications) |
|---|---|
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications. | Functions as an ultrasound system to perform diagnostic imaging for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel), including support for modes like B, M, PWD (Pulsed Wave Doppler), CWD (Continuous Wave Doppler), Color Doppler, and Combined Modes. It also includes "new indications" (N) and "previously cleared" (P) uses based on prior submissions. |
| Technological Characteristics: Specifications for image acquisition and display, system dimensions, electrical safety, and environmental robustness. | - Transducer frequencies: 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, 8L4) |
- Frame rate: 15 - 58 fps (Imaging only)
- Ultrasound lines/frame: 128
- Fields of View: 2.5 - 24 cm
- External Video Output: Composite Video, VGA Monitor
- Liquid-Crystal Display: 10.4" XVGA TFT
- Size: 11.6" W x 9.3" H x 1.65" D
- Weight: Laptop 4.84 lb, Smart Probe 10 oz
- Electrical Safety: IEC 601-1, UL 2601, Can/CSA C22.2 601.1 compliant; Class I, Type BF protection; max 50 μA leakage, primary breakdown >1500 V AC.
- Environmental: EC 68-2-27 compliant for mechanical shock, IEC 68-2-6 for mechanical vibration (Smart Probe only); 3ft drop test (Smart Probe only); 0-50°C operating temperature (Smart Probe only); 20-80% RH humidity; watertight transducer array; 63-101.3 Kpa altitude. |
| Safety: Device must meet recognized safety standards. | Meets IEC 601-1, UL 2601, Can/CSA C22.2 601.1 standards for electrical safety. Acoustic output measurements are required post-clearance. |
| Effectiveness: Device is sufficiently effective for its intended diagnostic purpose comparable to predicates. | The device is deemed "substantially equivalent" to predicate devices, implying comparable effectiveness based on its technical characteristics and intended uses. No specific performance metrics (e.g., diagnostic accuracy, sensitivity, specificity) are provided for comparison in this summary document. |
Regarding the other specific points, the document provides no information:
- Sample size used for the test set and the data provenance: Not applicable or not provided. This document doesn't describe a specific performance study with a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable or not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not provided.
- 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: Not applicable. This device is a standard ultrasound system, not an AI-driven image analysis tool requiring such studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a diagnostic imaging system operated by a human.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.