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510(k) Data Aggregation
(29 days)
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW and CW Spectral Doppler, CPA, Tissue Harnonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Musculo-skel. (Conventional), Other (Ob/GYN, Urology, Nerve), Cardiac Adult, Cardiac Pediatic, Peripheral Vessel and Carotid. The clinical environments where the used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where the intensity of electromagnetic disturbances is high.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the InnoSight diagnostic ultrasound:
- 64 Channel all digital beam former
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native frequency digital scan converter
- . InnoSight diagnostic ultrasound can be hand carried for portable use
- . Full patient database solutions: DICOM3.0, MP4 /PNG, USB, SSD, PDF report
- Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine . mode
Here's a breakdown of the acceptance criteria and the study information for the InnoSight Diagnostic Ultrasound System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) Premarket Notification, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance metrics for the InnoSight system itself from an independent study.
Instead, the "acceptance criteria" are implied by compliance with various international and FDA-recognized consensus standards for medical electrical equipment, including safety, electromagnetic compatibility, and acoustic output. The "reported device performance" is essentially the statement of compliance with these standards and the demonstration of equivalent functionality to the predicate device.
| Category | Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance) and IEC 60601-2-37 (particular requirements for ultrasonic medical diagnostic and monitoring equipment). | "InnoSight diagnostic ultrasound has been designed to meet the following voluntary and measurement standards: AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)" and "IEC 60601-2-37 Edition 2.1 2015". Non-clinical performance testing demonstrates compliance. Asserts that the device is "designed and manufactured to the same electrical and physical safety standards" as the predicate. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (general requirements for basic safety and essential performance – collateral standard: electromagnetic compatibility). | "AAMI / ANSI / IEC IEC 60601-1-2, Ed. 4.0". Non-clinical performance testing demonstrates compliance. |
| Acoustic Output | Compliance with NEMA UD 2-2004 (R2009) (acoustic output measurement standard for diagnostic ultrasound equipment) and IEC 60601-2-37. Acoustic output levels within Track 3 FDA limits. | "NEMA UD 2-2004 (R2009)" and "IEC 60601-2-37 Edition 2.1 2015". "Acoustic Output: Conform to IEC60601-2-37 and AIUM UD2 requirements for all modes of all probes." "The predicate device and InnoSight Diagnostic Ultrasound Systems have acoustic output levels within the Track 3 FDA limits." |
| Biocompatibility | Compliance with ISO 10993-1 (biological evaluation of medical devices). | "ISO 10993-1 Fourth Edition 2009-10-15". "The predicate device and the InnoSight Diagnostic Ultrasound Systems are manufactured by bio safety materials." Specifies that for transducer C83B, Cytotoxicity, Irritation and Sensitization tests reference the acceptable results for predicate transducer L154BH. |
| Software Life Cycle | Compliance with IEC 62304 (medical device software – software life cycle processes). | "IEC 62304:2015". |
| Image Quality & Functionality | "Ability to collect clinically acceptable images and ultrasound data for clinical applications" (stated as mechanism of action for predicate, implied for submission device). Equivalence to predicate in imaging functions (B, M, PWD, Color Doppler, THI, CPA, iScan, X-Res, SonoCT, Biopsy guide) and post-processing functions. Clinical verification expected, but not explicitly detailed numerically as performance metrics in this document. | The comparison table (pages 14-16) generally states "Same" or "No new imaging function" / "No new post processing function" when comparing features with the predicate CX50 and Sparq. Minor differences in probe types/bandwidth, display size, and number of channels are acknowledged but deemed "tested to prove that they [are] effective" or "safe and effective". Non-clinical verification testing covered system level requirements and risk control measures. Non-clinical validation testing covered intended use, commercial claims, and usability with representative intended users. |
| Intended Use | The system should be suitable for diagnostic ultrasound imaging and fluid flow analysis in various specified applications (Fetal, Abdominal, Pediatric, Small Organ etc.) and clinical environments. | The "Indications for Use" section (pages 2-8) details the specific applications and modes of operation for the InnoSight system and its various transducers. The comparison with the predicate device states, "No new indications" meaning the InnoSight performs for the same indications as the predicate. |
Specific Numerical Performance Targets (Acceptance Criteria) are not provided in detail in this document. The submission hinges on substantial equivalence to a predicate device, supported by compliance with recognized standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or images for evaluating clinical performance. The non-clinical testing involved various engineering tests (e.g., electrical safety, EMC, acoustic output, biocompatibility) conducted on the device itself.
- Data Provenance: The data described is primarily from non-clinical performance testing conducted on the device. There is no mention of clinical data (patient data) provenance (e.g., country of origin, retrospective or prospective) because the document explicitly states: "The InnoSight did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System demonstrated with indication for use, technological characteristics, Non-clinical performance testing; and Safety and effectiveness."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as there was no clinical test set requiring expert ground truth establishment for a diagnostic performance study. The evaluation focused on engineering performance and substantial equivalence.
4. Adjudication Method for the Test Set
- This information is not applicable as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission explicitly states that clinical data was not required.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not conducted or described in this document. The InnoSight system is a diagnostic ultrasound device designed to be operated by a trained medical professional, not an AI algorithm performing diagnostic tasks without human interaction.
7. Type of Ground Truth Used
- Not directly applicable in the context of a clinical diagnostic performance study. For the non-clinical tests, the "ground truth" would be established by the specifications of the standards (e.g., a device must operate within specific acoustic output limits as defined by NEMA UD 2).
8. Sample Size for the Training Set
- This information is not applicable. The InnoSight Diagnostic Ultrasound System is a hardware-based imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "training" involves engineering design, calibration, and adherence to established physical and electrical principles of ultrasound.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the reason stated in point 8.
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(160 days)
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.
InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the InnoSight diagnostic ultrasound:
- 64 Channel all digital beam former .
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native frequency digital scan converter
- InnoSight diagnostic ultrasound can be hand carried for portable use
- Remote access image management through LAN port
- Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm performance perspective. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, safety considerations, and general technical specifications of an ultrasound system.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as they are not present in the given text.
The "Predicate Device Comparison" table lists various technical specifications and operating controls for the submitted device (InnoSight Diagnostic Ultrasound System) and two predicate devices (BenQ UP600 and Philips CX50 and Sparq). This comparison is used to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing or proving specific performance acceptance criteria for a new, AI-driven functionality.
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