(32 days)
The HDI 5000 system is intended for ophthalmic, fetal, abdominal, intraoperative, pediatric, small organ, adult and neonatal cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal (conventional and superficial) intended uses as defined in the FDA guidance document.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal, vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel.
The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, M-mode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA), 3D, or in a combination of modes. The HDI 5000 system 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 HDI 5000 has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Advanced Image Processing is a feature upgrade to the HDI 5000 Ultrasound System that adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality. The sub-systems affected by the software algorithms include the beamformer, signal processing, and image processing modules. The enhanced DSP hardware approximately doubles the image processing power of the HDI 5000 system, allowing processed images to be generated in real time with no loss of frame rate. The benefits of Advanced Image Processing include enhanced contrast resolution, improved tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces.
The provided document is a 510(k) summary for the HDI® 5000 Ultrasound System with Advanced Image Processing. It focuses on the substantial equivalence to a predicate device and safety standards, rather than detailing specific acceptance criteria and a performance study in the way a clinical study report would.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.
Here's an attempt to answer based on the available information, highlighting what is missing:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria for image quality improvements due to "Advanced Image Processing." Instead, it describes the benefits of the feature.
Table of Acceptance Criteria and Reported Device Performance (Based on descriptive claims, no quantitative metrics provided):
| Acceptance Criterion (Implied Benefit) | Reported Device Performance (Descriptive) |
|---|---|
| Enhanced contrast resolution | Provided by enhanced DSP hardware and proprietary software algorithms. |
| Improved tissue texture definition | Provided by enhanced DSP hardware and proprietary software algorithms. |
| Clutter reduction | Provided by enhanced DSP hardware and proprietary software algorithms. |
| Better definition of tissue interfaces | Provided by enhanced DSP hardware and proprietary software algorithms. |
| Better continuity of tissue interfaces | Provided by enhanced DSP hardware and proprietary software algorithms. |
| Real-time image generation | Achieved with no loss of frame rate due to enhanced DSP hardware. |
Acoustic Output Limits (Specific acceptance criteria, but not directly related to image quality performance of the "Advanced Image Processing" feature):
| Acoustic Output Metric | Acceptance Criteria (Maximum/Range) | Reported Device Performance |
|---|---|---|
| All Applications Other Than Ophthalmic: | ||
| ISPTAd | 720 mW/cm² (Maximum) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| TIS/TIB/TIC | 0.1 - 6.0 (Range) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| Mechanical Index (MI) | 1.9 (Maximum) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| ISPPAd | 0 - 700 W/cm² (Range) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| Ophthalmic Applications: | ||
| ISPTAd | 50 mW/cm² (Maximum) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| TIS at Surface / Thermal Index (TIC) | 0.1 - 1.0 (Range) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| Mechanical Index (MI) | 0.23 (Maximum) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
| ISPPAd | 0 - 50 W/cm² (Range) | Not explicitly stated as "met," but implied by "The limits are same as predicate Track 3 devices" and the clearance. |
Study Information (Based on available text, much of this is not detailed):
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document describes a feature upgrade and states "The HDI 5000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound system." The "Advanced Image Processing" feature "adds enhanced DSP image processing hardware and proprietary software algorithms to improve 2D image quality." No specific test set to evaluate this improvement is described in terms of cases or images.
- Data Provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. Given the nature of a 510(k) for an ultrasound system feature upgrade focusing on image quality, it's possible qualitative comparisons were made by internal experts, but this is not documented here.
- Qualifications of Experts: Not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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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:
- MRMC Study: No MRMC comparative effectiveness study is described in this document. The "Advanced Image Processing" is presented as a general improvement to image quality, not as an AI assistance tool requiring a human-in-the-loop performance evaluation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The document describes the technical enhancements (enhanced DSP hardware and proprietary software algorithms) that improve 2D image quality. This enhancement is the "standalone" operation of the feature, as it processes the acquired ultrasound data to produce a better image. However, no quantitative standalone performance metrics (e.g., specific image quality scores, SNR improvements, contrast-to-noise ratio measurements, etc.) are provided for the "Advanced Image Processing" feature itself. The safety and effectiveness are established through substantial equivalence to a predicate device and adherence to safety standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not specified. For improvements in "contrast resolution, tissue texture definition, clutter reduction, and better definition and continuity of tissue interfaces," ground truth would typically refer to a reference standard against which image quality improvements are objectively measured. This could involve phantom studies with known properties or expert qualitative assessment of images. Neither is detailed here.
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The sample size for the training set:
- Sample Size: Not specified. Given that "proprietary software algorithms" are mentioned, implying some level of algorithm development, a training set might have been used if machine learning/AI was involved. However, the document predates widespread terminology like "AI" in medical devices, and the description focuses on DSP and algorithms rather than explicit machine learning. Therefore, a "training set" in the modern sense might not have been applicable or documented as such.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not specified. See point 7 regarding the nature of the "algorithms."
Summary of what's provided for acceptance criteria and study:
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (General Electric System Five) and adherence to electromechanical and acoustic output safety standards (IEC 601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, IEC 601-1-2, AIUM/NEMA 1992). The "Advanced Image Processing" feature is described in terms of its technical components (DSP hardware, software algorithms) and the perceived benefits it offers to image quality, such as "enhanced contrast resolution" and "improved tissue texture definition." However, the document does not present a formal study with quantitative acceptance criteria and detailed performance metrics specifically for the image quality improvements of this feature. The clearance implies that the FDA found the claims of effectiveness and safety to be sufficiently supported for substantial equivalence, without requiring a detailed clinical performance study report as would be expected for a novel device or AI algorithm today.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.