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The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc.), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

The M5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

The provided text describes a 510(k) Pre-Market Notification for the KOS-3001 M5 Diagnostic Ultrasound System. It asserts substantial equivalence to predicate devices and describes the intended use and safety considerations. However, it does not contain any information regarding acceptance criteria or a specific study proving the device meets those criteria.

The document mainly focuses on:

• Device Identification: Name, submitter, date prepared.
• Classification: Regulatory class, review category, product codes.
• Marketed Devices: Listing predicate devices for substantial equivalence.
• Device Description: General description, modes of operation, probe types, and frequency range.
• Intended Use: Clinical applications for which the device is intended.
• Safety Considerations: Compliance with FDA guidance and medical device safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, etc.).
• FDA Clearance Letter: Formal letter from the FDA stating substantial equivalence and listing cleared transducers and their clinical applications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving these criteria are met, as this information is not present in the provided text.

To answer your specific questions in the context of this document:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document asserts safety and effectiveness through compliance with standards and substantial equivalence to predicate devices, but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
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 available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
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 available in the provided text. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no mention of an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text.
8. The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

Here's an analysis of the provided text regarding the GE Vivid-i and Vivid-q Diagnostic Ultrasound System.

Acceptance Criteria and Study for GE Vivid-i and Vivid-q Diagnostic Ultrasound System (K082374)

Based on the provided document, the GE Vivid-i and Vivid-q Diagnostic Ultrasound System's acceptance criteria and proof of their being met are primarily based on substantial equivalence to a predicate device and compliance with recognized safety and quality standards, rather than a clinical performance study with specific quantitative acceptance criteria or statistical measures of device performance.

The document states: "The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems."

And under "Conclusion": "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vivid-i and Vivid -d Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

Furthermore, it explicitly states under "Clinical Tests: None required."

Therefore, the "acceptance criteria" here are framed around demonstrating equivalence to existing, legally marketed devices and adherence to established regulatory and engineering standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no specific quantitative performance metrics from a clinical study are reported, the table reflects the qualitative acceptance criteria related to substantial equivalence and safety/quality standards.

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

• Sample Size for the Test Set: Not applicable. No clinical test set or study validating specific performance metrics (like sensitivity/specificity) was conducted. The clearance is based on substantial equivalence to a predicate device and adherence to manufacturing and safety standards.
• Data Provenance: Not applicable for a performance test set. The predicate device (GE Vivid-i Ultrasound System, K061525) and other cleared GE Ultrasound systems provide the basis for equivalence.

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

• Not applicable. No new clinical trials or studies requiring ground truth establishment by experts for specific diagnostic performance were conducted for this 510(k) submission. The safety and effectiveness are inferred from the predicate device and the known history of diagnostic ultrasound.

4. Adjudication method for the test set

• Not applicable. No performance test set requiring adjudication was conducted.

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 submission does not involve AI. The device is a diagnostic ultrasound system.

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

• No. This submission does not involve an algorithm. The device is a diagnostic ultrasound system.

7. The type of ground truth used

• Not applicable. No new clinical performance data requiring ground truth was generated. The approval relies on the established safety and effectiveness of the predicate device and the general class of diagnostic ultrasound systems.

8. The sample size for the training set

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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