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510(k) Data Aggregation
(28 days)
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM
The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use.
Typical examinations shall include:
- General abdominal and pelvic studies including organ surveys and retroperitoneal cavity studies.
- Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
- Pediatric scans of organs. .
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility applications. .
- First, second and third trimester pregnancy studies. .
- Prostate, prostate biopsy guidance, and rectal wall studies. .
- Neonatal cephalic studies. .
- Transcranial studies of middle cerebral arteries, internal carotid artery, . and vertebral arteries.
- Cardiac studies in adults and children. .
- Biopsy guidance for tissue or fluid sampling. .
- Ophthalmic studies of the eye and surrounding structures and studies to . obtain blood flow information in the eye and surrounding structures.
- Conventional and superficial musculoskeletal studies. .
This 510(k) adds the musculoskeletal applications (superficial and conventional) to the HDI 1000 system.
The HDI 1000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. The HDI 1000 system functions by acquiring ultrasound data and displaying it on a monitor in 2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.
The HDI 1000 system is designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.
The HDI 1000 system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 11.0 MHz
scanhead types: flat linear array, curved linear array, phased array
Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.
This 510(k) premarket notification (K980860) concerns the Atlantis Diagnostics International, Inc. (ADII) HDI® 1000 Ultrasound System, specifically for the addition of musculoskeletal (conventional and superficial) indications for use. The submission doesn't detail a specific study with acceptance criteria and performance metrics in the typical sense for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to predicate ultrasound devices already on the market.
For ultrasound systems, the "acceptance criteria" are generally related to demonstrating that the device performs as intended for the specified clinical applications, meets safety standards (electromagnetic compatibility, acoustic output), and has technological characteristics that are substantially equivalent to legally marketed predicate devices. The "study" proving this is implicitly the comparison presented in the 510(k) submission, alongside adherence to relevant safety standards.
Here's a breakdown based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an ultrasound system and not an AI/CADe product, the typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria and performance are focused on safety, functionality, and equivalence to predicate devices, particularly regarding acoustic output and imaging modes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Acoustic Output Limits (Non-Ophthalmic Applications): | |
| - ISPTAd ≤ 720 mW/cm² | - ISPTAd: 720 mW/cm² (Maximum) |
| - TIS/TIB/TIC: 0.1 - 4.0 | - TIS/TIB/TIC: 0.1 - 4.0 (Range) |
| - Mechanical Index (MI) ≤ 1.9 | - Mechanical Index (MI): 1.9 (Maximum) |
| - ISPPAd: 0 - 700 W/cm² | - ISPPAd: 0 - 700 W/cm² (Range) |
| Acoustic Output Limits (Ophthalmic Applications): | |
| - ISPTAd ≤ 50 mW/cm² | - ISPTAd: 50 mW/cm² (Maximum) |
| - Thermal Index (TIC): 0.1 - 1.0 | - Thermal Index (TIC): 0.1 - 1.0 (Range) |
| - Mechanical Index (MI) ≤ 0.23 | - Mechanical Index (MI): 0.23 (Maximum) |
| - ISPPAd: 0 - 50 W/cm² | - ISPPAd: 0 - 50 W/cm² (Range) |
| Substantial Equivalence: | |
| - Imaging Modes (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, Pulsed Doppler) | - "The modes of these devices (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices." |
| - Scanhead Biocompatibility | - "Scanhead patient contact materials are biocompatible and are also the same as the identified predicate devices." |
| - Compliance with Safety Standards | - Designed to meet EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2. Conforms to AIUM/NEMA 1992 for on-screen display of thermal and mechanical acoustic output indices. Implicitly, the specified acoustic output limits are the performance metrics against which it was tested for compliance. |
| - Intended Use (including new musculoskeletal applications) | - The filing seeks to add musculoskeletal applications (conventional, superficial) to the existing range of indications, asserting that the HDI 1000 system, with its specified transducers, is substantially equivalent for these uses. The device's acoustic output limits for all applications (including musculoskeletal implicitly) are within the ranges of predicate Track 3 devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical performance study with a "test set" in the context of imaging performance for diagnosis. The assessment for this ultrasound system focuses on engineering and safety specifications, and comparison to predicate devices.
- Sample Size: Not applicable/not specified for a typical "test set" of diagnostic images.
- Data Provenance: Not applicable. The data presented relates to device specifications and compliance with standards, not patient data for diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As there is no diagnostic performance test set, there is no mention of experts or ground truth establishment in this context. The "ground truth" for an ultrasound system primarily revolves around its ability to produce images and Doppler information correctly and safely based on physical principles, as demonstrated through engineering tests and comparison to established predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic performance test set is described.
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
Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe device. Therefore, no MRMC study comparing human readers with and without AI assistance would be included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
The ground truth used in this submission is the engineering specifications, safety standards, and established performance characteristics of legally marketed predicate ultrasound devices. The applicant demonstrates that the HDI® 1000 Ultrasound System, particularly for its new musculoskeletal indications, adheres to these technical and safety "ground truths" and is substantially equivalent to the predicate devices in its operation and output.
- Ground Truth: Engineering specifications, acoustic output limits, compliance with international safety standards (e.g., EN 60601-1, AIUM/NEMA 1992), and functional characteristics (imaging modes, transducer types, frequency range) as defined by the industry and regulatory bodies for diagnostic ultrasound equipment.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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