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Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continous wave Doppler (CW Doppler), Color Flow Mapping (CFM) adn Color Time motion (CM mode).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.

The provided document is a 510(k) Premarket Notification from Kontron Medical for their Sigma 5000 series, Imagic ultrasound system. It is a declaration of substantial equivalence to a predicate device (Kontron Medical Sigma 110/330, K002239), and not a study proving the device meets specific performance criteria through clinical trials. The document explicitly states:

"Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required."

Therefore, the device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting pre-defined acceptance criteria through a specific study with a test set of data.

Given this, I cannot extract the requested information regarding acceptance criteria and performance from a study because such a study was not conducted or reported in this document.

However, I can summarize the non-clinical tests that were performed and the basis for the substantial equivalence claim.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics being the same as the predicate device, not on meeting specific quantitative performance metrics from a clinical study.

2. Sample size used for the test set and the data provenance: Not applicable. No test set of data from clinical studies was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from a clinical test set.

4. Adjudication method for the test set: Not applicable. No test set or expert adjudication was 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 document predates widespread AI in medical imaging and focuses on ultrasound system equivalence, not AI effectiveness.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm-only performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The equivalence is based on the technological characteristics of the device being the same as the predicate device.

8. The sample size for the training set: Not applicable. No machine learning algorithm training was mentioned or evaluated.

9. How the ground truth for the training set was established: Not applicable. No machine learning algorithm training was mentioned or evaluated.

Information that can be extracted regarding device acceptance:

The device's acceptance is based on its substantial equivalence to Kontron Medical Sigma 110/330 (K002239). The reasoning provided is that:

• The technological characteristics of the new device (Sigma 5000 series, Imagic) are the same as those of the predicate device.
• The device has been evaluated for non-clinical tests: acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, and has been found to conform to applicable medical device safety standards.
• The design and development process conforms with 21 CFR 820 Quality System Regulation and ISO13485 quality system standards.
• Compliance is verified through independent evaluation with ongoing factory surveillance.
• Diagnostic ultrasound has a long history of safe and effective performance.

Therefore, the acceptance criteria implicitly rely on the predicate device's established safety and effectiveness through conformity to standards and regulations, rather than new clinical performance data for this specific device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Modes of Operation: B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).

The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.

The Kontron Medical Sigma 5000 series, Imagic ultrasound system is a medical diagnostic ultrasound imaging system.

Here's an analysis of the provided text regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or quantifiable performance metrics for the device. Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Kontron Medical Sigma 110/330, K002239) and compliance with relevant safety and quality standards.

The reported device performance is broadly stated as conformant with applicable medical device safety standards and consistent with traditional clinical practice and FDA guidelines.

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

No specific test set or data provenance (country of origin, retrospective/prospective) is described for the clinical performance of the device. The submission explicitly states: "Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required."

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

Since clinical tests were not required, there is no mention of a test set, experts, or ground truth establishment in this context.

4. Adjudication Method for the Test Set

Not applicable, as no external test set with expert adjudication was used for clinical performance.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in this device. This is a conventional diagnostic ultrasound imaging system.

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

This is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically linked to human operation and interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the purpose of demonstrating substantial equivalence, the "ground truth" implicitly relies on the established safety and effectiveness of the predicate device (Kontron Medical Sigma 110/330, K002239) and general clinical consensus regarding the safe and effective performance of ultrasound technology. No new ground truth specific to this device's clinical performance was established via studies mentioned in this document.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware and software system, not a machine learning model that requires a training set in this context. Its "training" or development likely involved engineering design, testing against specifications, and conformity to standards, rather than data-driven model training.

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this device.

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