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The SonoScape S8 Exp/S9 Pro system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a portable console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D. The subject of this submission is the addition of new probes to the legally marketed SonoScape S8 Exp/S9 Pro. Add 3C-A, 4P-A and 10l2 probes. New probes

This document is a 510(k) Pre-market Notification from SonoScape Medical Corp. to the FDA for their S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System. It is an application for substantial equivalence to a previously cleared device. Therefore, the "acceptance criteria" and "device performance" are established by comparing the new device against the predicate device.

Here's an analysis based on the provided document, addressing your specific points:

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

The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device. For ultrasound systems, this typically involves matching or demonstrating comparable performance in various imaging modes and across different clinical applications and transducers, while ensuring safety standards are met.

The reported device performance is presented as a comparison to the predicate device, asserting that the new device has "the same intended uses" and "the same basic and key technical features." For the newly added probes, specific demonstrations of their performance and clinical application being equivalent to existing cleared probes are given.

• 3C-A Curved Array: Performance and clinical application are the same as the C344 Curved Array. Both meet clinical use despite slight frequency differences.
• 4P-A Phased Array: Performance and clinical application are the same as the 3P1 Phased Array. Both meet clinical use despite slight frequency differences.
• 10L2 Linear Array: Frequency, performance, and clinical application are the same as the L741 Linear Array. |
  | Safety and Standards Compliance: Device meets applicable electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output safety standards. | Compliant: Evaluated for electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility, and acoustic output. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3. Acoustic output levels are consistent with predicate. No new risks raised. |

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

The document explicitly states "No clinical testing was required" for this 510(k) submission. This means no patient test set was used for proving substantial equivalence in a clinical context. The evaluation was based on non-clinical (laboratory) tests and comparison to a predicate device.

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)

Since no clinical testing was required and no patient test set was used for establishing clinical performance, there were no experts used to establish ground truth from clinical data. The "ground truth" for proving substantial equivalence was implicitly based on the technical specifications and performance characteristics of the predicate device and the new device.

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

Not applicable, as no clinical test set was used.

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 device is an ultrasound system, not an AI diagnostic aid. No MRMC study was mentioned or required for this submission.

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

Not applicable. This is a medical imaging device, not an algorithm being evaluated for standalone diagnostic performance. The performance evaluated is of the hardware and integrated software for acquiring and displaying ultrasound images.

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

The "ground truth" in this context is the established performance and safety of the previously cleared predicate device (SonoScape S8 Exp/S9 Pro, K142714). The assessment for the new device relied on:

• Established technical specifications and performance characteristics of both the predicate and the new device.
• Compliance with recognized industry standards (e.g., IEC 60601 series, ISO 10993 series).
• Laboratory (Phantom) tests to verify that the system met design specifications.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data for an algorithm.

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

Not applicable. As this is not an AI/ML device, there was no "training set" in the context of machine learning.

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The SonoScape S8 Exp/S9 Pro system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

The SonoScape S8 Exp/S9 Pro system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

This SonoScape S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a portable console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

The subject of this submission is the addition of new indications, new probes and special function to original SonoScape S8 Exp and the addition of SonoScape S9 Pro.

The provided document is a 510(k) premarket notification for the SonoScape S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed information requested.

Therefore, many of the requested categories cannot be directly extracted from this document, as it outlines a regulatory submission process based on comparison, not a direct performance study to meet new acceptance criteria for a novel device.

However, I can extract the following information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the typical sense of a novel device's performance metrics. Instead, "acceptance" is implicitly tied to demonstrating substantial equivalence to existing predicate devices. Therefore, the "reported device performance" is primarily presented as its similarity and compliance with standards already met by predicate devices.

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

• Sample Size for Test Set: Not applicable. The document discusses non-clinical tests (laboratory tests, phantom tests) but does not refer to a "test set" of clinical cases or patient data with a defined sample size for performance evaluation in the context of a new acceptance criterion.
• Data Provenance: Not applicable in the context of a clinical test set. The non-clinical tests were conducted internally by SonoScape Company Limited.

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

• Not applicable. No clinical test set requiring expert ground truthing is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication 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:

• No MRMC comparative effectiveness study was done or mentioned. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

• Not applicable. The document describes an ultrasound system, which is inherently a human-operated device. It's not an "algorithm only" device for standalone performance.

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

• For the non-clinical tests mentioned, the "ground truth" would be established by physical measurements and expected outcomes from phantom models and engineering specifications (e.g., accuracy and repeatability of strain-ratio measurement for Elastography).

8. The sample size for the training set:

• Not applicable. This document does not describe the development of an AI algorithm requiring a training set.

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

• Not applicable. This document does not describe the development of an AI algorithm requiring a training set.

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