(281 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Obstetrical, Cerebrovascular, Peripheral vascular, Gynecological and fertility, Small parts, Intraoperative vascular, Abdominal surgery, Musculoskeletal (conventional), Transcranial Doppler, Pediatric general imaging, Prostate, Adult cardiology, Pediatric cardiology.
The SA 8800/HDI 1500 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, Mmode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA 8800/HDI 1500 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA 8800/HDI 1500 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Eight different models of transducers are available and any three may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, usercustomized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials are the same as those previously cleared in the predicate device, ATL's HDI 5000 Ultrasound System and Transducers (K961459). The SA-8800/HDI 1500 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 12.0 MHz. These probes can be applied to a variety of clinical applications such as abdominal, obstetrical, cerebrovascular, peripheral vascular, gynecological and fertility, small parts, intraoperative, vascular, abdominal surgery, conventional musculoskeletal, transcranial Doppler, pediatric general imaging, prostate, adult cardiology, pediatric cardiology. The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459). The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The Biopsy guides are the same as those previously cleared for the predicate device, ATL's HDI 5000 system (K961459). The operating Modes of SA-8800/HDI 1500 are B-Mode, M, Color-Flow Doppler, Continuous wave (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, or as a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor. The SA8800/HDI 1500 supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression. via a Dicom 3.0 compatible output. Management of patient history is possible by imagefiling function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The provided document is a 510(k) summary for the Medison America, Inc. SA 8800/HDI 1500 Ultrasound System, dated August 21, 1998. It details the device's characteristics and its substantial equivalence to a predicate device (ATL HDI 5000 System, K961459).
This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting an extensive study with specific acceptance criteria, sample sizes, and detailed performance metrics as would typically be found for novel AI devices or those requiring de novo classification.
Therefore, the information regarding acceptance criteria, study details, and performance metrics in the context of proving the device meets specific acceptance criteria in the way it's typically understood for new diagnostic algorithms (e.g., sensitivity, specificity, AUC values against a ground truth) is not present in this document. The device is a diagnostic ultrasound system, and its performance is established through comparison to a similar existing device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
There are no explicit numerical acceptance criteria (e.g., minimum sensitivity/specificity) or detailed performance metrics (like those used for novel algorithms) presented in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, ATL HDI 5000 System (K961459), in terms of intended use, technological characteristics, and safety standards.
The document states:
- "Medison America, Inc believes that SA8800/HDI 1500 Ultrasound system is substantially equivalent to the currently marketed ATL HDI 5000 System, K961459." (Section 3)
- "This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode, Continuous wave Doppler, Spectral Doppler, Color Doppler, Power Doppler, 3D images." (Section 6)
- "The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459)." (Section 4)
- "The device's acoustic output limits are the same as predicate Track 3 devices." (Section 6)
The "performance" is considered equivalent to the predicate device, which is already legally marketed and presumed safe and effective.
No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for diagnostic capabilities are provided for the SA 8800/HDI 1500 or its predicate in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No specific test set or clinical study data (including sample sizes, data provenance, or study design) are mentioned in this 510(k) summary for establishing performance against criteria. Such detailed clinical study data is typically not required for 510(k) submissions that demonstrate substantial equivalence to a predicate device with well-established performance and intended uses.
3. 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)
As no specific clinical study data is presented, there is no information about experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information on adjudication methods for a test set is provided, as no specific clinical study data is presented.
5. 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 MRMC study was mentioned. The device described is a general-purpose diagnostic ultrasound system, not an AI-assisted diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a complete ultrasound system, not a standalone algorithm. Its performance inherently involves human operation and interpretation. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As no specific clinical study data is presented, information about the type of ground truth used is not available.
8. The sample size for the training set
No information about a training set is provided, as the submission focuses on substantial equivalence of a hardware/software system, rather than a novel algorithm development requiring a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned.
Summary of Device Acceptance Approach:
The Medison America, Inc. SA 8800/HDI 1500 Ultrasound System gained market acceptance through the 510(k) Premarket Notification Pathway. This pathway relies on demonstrating substantial equivalence to a predicate device (ATL HDI 5000 System, K961459) that is already legally marketed in the US.
The "acceptance criteria" are generally met by proving that the new device:
- Has the same intended use as the predicate device.
- Has similar technological characteristics to the predicate device.
- Raises no new questions of safety or effectiveness.
The study proving the device meets these (implicit) acceptance criteria is the substantial equivalence comparison itself, documented in the 510(k) submission. This comparison involves:
- Detailed description of the new device (SA 8800/HDI 1500) including its modes of operation, available transducers, measurement capabilities, and safety standards compliance.
- Identification of the predicate device (ATL HDI 5000 System, K961459).
- Direct comparison of intended uses: The document explicitly states the SA 8800/HDI 1500 has the same clinical uses as the predicate, and lists them (e.g., Abdominal, Obstetrical, Cardiac, etc.). The indications for use tables (pages 6-14 of the document excerpt) show which transducers are cleared for which applications, often noting 'P' for "previously cleared in K961459" or 'N' for "new indication" (which would then require further justification not detailed in this summary).
- Direct comparison of technological characteristics: The document states the device operates "identical to the predicate devices" in fundamental principles (piezoelectric material, sound wave reflection, electrical signal processing and display modes).
- Comparison of acoustic output limits: The document explicitly states the device's acoustic output limits (ISPTA: 720 mW/cm2, MI: 1.9) are "the same as predicate Track 3 devices."
- Biocompatibility of patient contact materials: Stated to be the same as previously cleared in the predicate device.
- Electromechanical safety standards compliance: The SA 8800/HDI 1500 has been designed to meet several electromechanical safety standards (EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157, EN 60601-1-2).
The 510(k) clearance letter (pages 4-5) confirms the FDA's agreement that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing its marketing subject to general controls and a post-clearance special report on acoustic output measurements from production line devices.
§ 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.