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The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:

LX Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve

128 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU700 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

The Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.

I. The imaging system software runs as an app on a mobile device.

II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.

III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.

IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

A complete list of all the probes and indications including:

Dual headed probe

LX Series:

LX128LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Convex transducer: Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LX128LP
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Phased Array transducer: ,Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LX192LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superf-dotorial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Convex transducer: ,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

Single headed probe

128 Series:

LK128C
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LK128L
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LK128LH
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LK128M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LK128PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LK128E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

LU700 Series:

LU700L
General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU710L
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU710LH
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710C
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LU710E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

The provided FDA 510(k) clearance letter and summary for Leltek Inc.'s Ultrasound Imaging Systems (K243226) address the addition of new dual-headed probes (LX series) to existing cleared devices. While it asserts that the new models meet safety and performance standards, the document does not provide specific acceptance criteria or detailed study results for device performance in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K241161) and compliance with various recognized standards (e.g., IEC 60601 series, ISO 10993 series). It states that "No additional clinical testing is required" due to the nature of the changes being additions of transducers with established technologies.

Therefore, the requested information cannot be fully extracted directly from this document. However, I can reconstruct what parts are mentioned or implied.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Request for Acceptance Criteria and Study Details

The provided document (FDA 510(k) Clearance Letter - Leltek Inc. Ultrasound Imaging Systems, K243226) details a submission for adding new dual-headed probes (LX series) to an already cleared Ultrasound Imaging System. It asserts that the new models meet safety and performance standards equivalent to the predicate device, thereby requiring no additional clinical testing.

The document does not provide specific acceptance criteria or detailed study results for device performance in the format of a comparative table or a comprehensive study description as requested for a new AI/software-based medical device. Instead, it relies on the principle of substantial equivalence and compliance with recognized standards for hardware modifications.

However, it does provide information on the safety and performance evaluations conducted to support the substantial equivalence.

Requested Information Breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as clear, quantifiable acceptance criteria or reported device performance metrics in the given document.
The document states that the devices comply with various standards, which inherently means they meet the performance requirements within those standards. It mentions:

• "full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness"
• "maximum acoustic output level is under the FDA recommended limit"
• "All the safety and performance tests of the device meet the essential requirements."

Without specific numerical targets for metrics like accuracy, sensitivity, or specificity (which are common for AI/software devices, but not the primary focus here for a hardware add-on to an imaging system), a table cannot be constructed. The performance is assessed against the established safety and performance of the predicate device and relevant industry standards.

2. Sample size used for the test set and the data provenance

Not applicable in the context of this 510(k) submission for new transducers.
The submission focuses on the safety and performance of the hardware (new transducers) and their integration with existing software. It explicitly states, "No additional clinical testing is required." Therefore, there is no mention of a clinical "test set" with patient data or its provenance. The testing would be on the physical device's characteristics (e.g., acoustic output, EMC, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical "test set" or diagnostic performance study is described, there's no mention of experts establishing ground truth for such a test.

4. Adjudication method for the test set

Not applicable. As no clinical "test set" or diagnostic performance study is described, there's no mention of an adjudication method.

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. This is not an AI/Software as a Medical Device (SaMD) submission focused on aiding diagnosis, but rather a submission for a new hardware component (ultrasound transducers) to an imaging system. Therefore, no MRMC study or AI assistance effect size is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an AI/SaMD submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of submission, the "ground truth" for demonstrating safety and performance relates to engineering specifications, physical measurements (e.g., acoustic output, electrical safety), and material properties (e.g., biocompatibility testing results), rather than clinical diagnostic accuracy against pathology or expert consensus.

8. The sample size for the training set

Not applicable. This submission is for hardware. There is no mention of a "training set" in the context of an algorithm or AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, this information is not available.

Summary of Device Safety and Performance Assessment (from the Document):

The document indicates that the substantial equivalence is established based on the following:

• Compliance with recognized standards: A comprehensive list of IEC and ISO standards for medical electrical equipment, usability, software lifecycle, biological evaluation (biocompatibility), risk management, and quality management is provided (Pages 14-15).
• Acoustic Output: The device is tested and determined to be in "full compliance with acoustic output" and the "maximum acoustic output level is under the FDA recommended limit" (Page 16).
• Biocompatibility: The new models are deemed to have "biosafety equivalence" and passed "biocompatibility" tests (Page 16).
• Cleaning and Disinfection: Demonstrated "cleaning, and disinfection effectiveness" (Page 16).
• Software and Hardware Equivalence: The new LX Series probes "utilizes the same software, cover material, and transducer specifications as the 128 Series but replaces a similar PCBA with a dual-headed probe, maintaining the same block diagram." (Page 16)
• No Pragmatic Detriments: The changes "have no pragmatic detriments" (Page 16).

In essence, Leltek Inc. demonstrated that the new LX series transducers behave similarly to their predicate devices and comply with relevant safety standards, thus no further clinical performance studies were deemed necessary for this specific 510(k) submission.

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