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The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Trans-esophageal(Cardiac), and peripheral vessel.

The HS50 / HS60 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, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 / HS60 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 HS50 / HS60 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The HS50 / HS60 uses digital multi-beam forming technology and supports a variety of Linear, Convex, Phased, Static and Volume 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 1.0 MHz to 20.0 MHz.

Here's a breakdown of the acceptance criteria and study information for the Samsung Medison HS50/HS60 Diagnostic Ultrasound System, based on the provided document:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it states that the device was evaluated to conform with applicable FDA guidance and medical device safety standards and that migrated probes and software functionalities were evaluated using the same test criteria as the predicates to ensure that migration from a 192-channel system to a 128-channel system did not compromise image quality with respect to the intended use of each feature. This implies that the acceptance criteria are tied to maintaining performance parity or non-inferiority with predicate devices and adhering to recognized safety and performance standards for diagnostic ultrasound systems.

The reported device performance is generally described qualitatively as being "as safe and effective" and "substantially equivalent" to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data. The non-clinical testing appears to be based on engineering evaluations, phantom studies, and possibly existing data from the predicate devices.

• Sample Size: Not explicitly stated for a "test set" of patient data.
• Data Provenance: The testing is primarily non-clinical, involving evaluations of acoustic output, software function, thermal, electrical, electromagnetic, and mechanical safety. The transducers were "migrated from previously cleared systems," suggesting that their performance characteristics were already established. If patient data was used for evaluating image quality related to "migration from a 192-channel system to 128-channel system," the document does not specify its origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable as the primary testing described is non-clinical and doesn't explicitly involve human expert evaluation of a "test set" of images for diagnostic accuracy against a ground truth in the context of a clinical study. The document mentions "competent health care professionals" use the device for diagnosis, but not in the context of establishing ground truth for the device's own performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is primarily non-clinical and doesn't involve clinical cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The document explicitly states: "The proposed device HS50 / HS60 Ultrasound System, did not require clinical studies to demonstrate substantial equivalence."

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes evaluations for specific software functionalities such as "E-Strain, Stress Echo, 2D NT, Crystal Vue, 5D Heart Color, BiometryAssist, HQ Vision, and S-Detect for Breast Lite." It states these were evaluated "using the same test criteria as the predicates for all applicable imaging modes to ensure that migration from a 192-channel system to 128-channel system did not compromise image quality with respect to the intended use of each feature." This implies that the performance of these functionalities themselves was assessed, which could be considered standalone in how the algorithm generates data or images. However, it's not a standalone diagnostic performance study for a specific clinical outcome.

7. The Type of Ground Truth Used

For the non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be the established engineering specifications, safety standards (e.g., IEC, NEMA), and the performance characteristics of the predicate devices. For software functionalities, the ground truth would likely involve technical benchmarks and comparison to outputs from the predicate devices or established methods. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this submission.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system and its transducers, not for a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software functionalities" mentioned are likely embedded algorithms and features, but the document doesn't detail their development or training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI algorithm.

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The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The HS50 / HS60 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, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 and HS60 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 HS50 / HS60 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text is a 510(k) summary for the Samsung Medison HS50/HS60 Diagnostic Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly available in this document.

However, I can extract information related to the device's technical characteristics and the general safety and effectiveness assessments.

Summary of Device Features and Equivalence:

The HS50/HS60 Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data and displays it in various modes (B, M, Color M, Anatomical, Color Doppler, Pulsed Wave (PW) Spectral Doppler, Continuous Wave (CW) Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Doppler (PD), ElastoScan, 3D/4D/XI STIC imaging, Dual, Quad, Combined, Simultaneous, and Zoom modes). It also provides measurement and analysis packages for diagnostic purposes.

The device's substantial equivalence to predicate devices (H60 (K143264), RS80A (K162094), WS80A (K153529), HM70A (K153408), and HS70A (K163691)) is claimed based on safety, effectiveness, and functionality. All systems transmit ultrasonic energy into patients, process echoes for display of anatomic structures and fluid flow, and allow for measurements and calculations.

Here's the information formatted to the best of my ability based on the provided text, acknowledging that direct "acceptance criteria" and "study results" in the sense of a new clinical claim are not present for this type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for a new clinical performance claim, as it is a 510(k) submission for substantial equivalence to existing devices. The "performance" is implicitly deemed equivalent if the device meets all safety standards and performs its intended functions similarly to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size, data provenance, or details of a clinical study to report from this document.

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)

Not applicable, as no clinical studies were performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies were performed.

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 is a 510(k) for a diagnostic ultrasound system, not an AI-based interpretation device claiming improved reader performance. The document explicitly states "Not applicable. The subject of this submission, HS50 / HS60, did not require clinical studies to support substantial equivalence."

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

Not applicable. This is a diagnostic ultrasound system, which is a human-operated device, not a standalone algorithm.

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

Not applicable, as no clinical studies were performed for a new performance claim. The ground for substantial equivalence relies on comparison to predicate devices, which are already cleared for clinical use.

8. The sample size for the training set

Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set in the typical sense for machine learning.

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

Not applicable.

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