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510(k) Data Aggregation
(31 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convox array, and sector probe with a frequency range of approximately 2 to 15 MHz. The system can operate in B mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.
The provided text describes a 510(k) premarket notification for the SHIMADZU MEDICAL SYSTEMS SDU-1100 Ultrasound Imaging System. This document generally focuses on establishing substantial equivalence to a predicate device based on intended use and safety standards, rather than detailing a specific clinical study with acceptance criteria and performance metrics described in clinical terms (e.g., sensitivity, specificity, accuracy).
Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and proven device performance as typically expected for clinical evaluation studies (e.g., diagnostic accuracy metrics) cannot be extracted. The acceptance criteria in this context are related to meeting established regulatory and safety standards, and demonstrating substantial equivalence for the stated indications for use.
Below is an attempt to structure the available information regarding acceptance criteria and the "study" (which in this case refers to the submission process for substantial equivalence).
Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)
The "acceptance criteria" for the SDU-1100, as presented in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards for ultrasound systems. The "reported device performance" is implicitly that the device meets these standards and is considered safe and effective for its indicated uses.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Category | Specific Criteria (Derived from 510(k) Summary) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Intended Use Equivalence | The device's intended uses must be substantially equivalent to a legally marketed predicate device. The SDU-1100 is intended for: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, and Musculo-skeletal Conventional applications. Specific transducers (L040-075U, L072-050U, L040-120U, VA13R-035U, VA13R-050U, VA20R-035U, VA40R-035U, VA40R-035HU, VA57R-0375WU, VA57R-0375HU, TV11R-055U, UB10R-065U) also have defined indications for use across various modes (B, M, PWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined, Tissue Harmonic Imaging). | The FDA has determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies the SDU-1100, including its transducers, performs adequately for its stated applications. |
| Technological Characteristics | The device must have technological characteristics (e.g., modes of operation: B, M, Pulsed Doppler, Color mode; transducers with specific frequency ranges of approximately 2 to 15 MHz) that are substantially equivalent to a predicate device, or where differences do not raise new questions of safety or effectiveness. | The FDA's substantial equivalence determination implies that the technological characteristics of the SDU-1100 are considered equivalent to the predicate device (GE Logiq 500, K991611) for the stated intended uses. |
| Safety and Performance Standards Adherence | The device must meet recognized voluntary and measurement standards for medical electric equipment, acoustic output, and real-time display of thermal and mechanical acoustic output indices. Specifically: | The device "has been designed to meet the following voluntary and measurement standards," and FDA clearance is based on this assertion, with a post-clearance special report requested to verify acoustic output measurements based on production line devices. This implies the device is deemed to meet these standards. |
| - IEC 60601-1 Safety of Medical Electric Equipment | ||
| - AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | ||
| - Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 (AIUM 1998) | ||
| - AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | ||
| Post-Clearance Acoustic Output Verification | Prior to shipping the first device, a post-clearance special report containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's September 30, 1997 "Information for Manufacturers of Diagnostic Ultrasound Systems and Transducers." | This is a condition for clearance, to be met post-clearance. The clearance is granted "on the condition that prior to shipping the first device, you submit a postclearance special report" to confirm approved acoustic output levels. |
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not mention a specific test set, sample size, or clinical data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for general ultrasound imaging systems typically rely on technical performance data, adherence to standards, and comparison to a predicate device rather than extensive new clinical studies to demonstrate diagnostic accuracy through a "test set" in the way a novel diagnostic algorithm might. The "study" here is the submission that demonstrates substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. Given that it's a submission for a general ultrasound imaging system, the "ground truth" is typically defined by existing medical consensus, established imaging protocols, and the performance characteristics of the predicate device. Clinical trials with expert-adjudicated ground truth are not typically a primary component of a 510(k) for this type of device unless new and complex claims are being made.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document does not describe a clinical study involving a test set needing expert adjudication.
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
This type of study is not mentioned in the provided document. The SDU-1100 is described as a diagnostic ultrasound imaging system, not an AI-powered diagnostic assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the SDU-1100 is a hardware imaging device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for substantial equivalence is generally based on:
- Established performance of the predicate device: The GE Logiq 500 (K991611).
- Compliance with recognized industry standards: IEC 60601-1, AIUM NEMA UD2, AIUM 1998 Acoustic Output Measurement and Labeling Standard, AIUM NEMA UD3. These standards define acceptable levels of safety and performance.
- Bio-compatibility and electrical safety testing: Implied by adherence to IEC 60601-1.
- Technical specifications and engineering data: Used to demonstrate that the device functions as intended and within safe limits (e.g., acoustic output).
8. The sample size for the training set
This is not applicable as the document describes a hardware device submission, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8.
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