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510(k) Data Aggregation
(30 days)
LOGIQ S7 Expert
The device is intended for use by a qualified physician for ultrasound evaluation of Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal: Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
The LOGIQ S7 Expert is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 530mm (Caster), 520mm (Keyboard), 565mm (Monitor) wide, 865mm deep and 1760mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color 23-inch LCD widescreen monitor.
The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ S7 Expert diagnostic ultrasound system. It outlines the device's indications for use and states its substantial equivalence to previously cleared devices. It explicitly mentions that clinical studies were NOT required to support substantial equivalence for this submission. Therefore, the document does not contain information about acceptance criteria for device performance based on a clinical study, nor does it present the results of such a study.
The submission focuses instead on demonstrating substantial equivalence through:
- Comparison to Predicate Devices: Showing that the LOGIQ S7 Expert shares the same fundamental scientific technology, clinical intended use, imaging modes, and similar capabilities (measurements, digital image capture, reviewing/reporting) as its predicate devices (K141261 LOGIQ S7 Expert, K152195 LOGIQ S8, K141639 Voluson S8, K143452 Logiq P9).
- Safety and Performance Testing: Confirming compliance with various safety standards related to acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.
- Software Features Migration: Listing new software features (STIC, OmniView, Cardiac AFI, Email2MMS) that were previously cleared on other GE ultrasound systems.
- Transducer Equivalence: Confirming that new transducers (C1-6-D, C3-10-D, P8D, BE9CS-D) are already cleared on predicate devices (LOGIQ S8), and a new S2-5-D probe is an incremental improvement to an existing one (3Sp-D) and deemed equivalent.
Since no clinical study was conducted as part of this submission, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not available as no clinical study was performed for this 510(k).
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- 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. The device is a diagnostic ultrasound system, not explicitly described as having AI features that would necessitate an MRMC study for improved reader performance. Even if it had such features, no clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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(21 days)
LOGIQ S7 EXPERT, LOGIQ S7 PRO
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); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 7-inch LCD touch screen and color 19-inch LCD image display.
The provided 510(k) summary for the GE Healthcare LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System states that no clinical studies were required to support substantial equivalence ([3], "Summary of Clinical Tests").
Therefore, this submission does not contain information regarding objective acceptance criteria, device performance from clinical studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to clinical outcomes.
The submission focuses entirely on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with voluntary safety standards. The new features and transducers are considered substantially equivalent if they are the same as those cleared on predicate devices (LOGIQ S8 (K131527) and LOGIQ P6 (K101874) or are new but equivalent to existing transducers ([2]).
Summary of Device Performance (as presented in the document):
The device performance is described in terms of its ability to meet various safety and technical standards, rather than clinical efficacy metrics.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| Acoustic Output | Demonstrated to be below applicable FDA limits ([2]). Compliance with NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices) and NEMA UD 2 (Acoustic Output Measurement Standard) ([2]). |
| Biocompatibility | Transducer materials and other patient contact materials are biocompatible ([3]). Compliance with ISO10993-1 (Biological Evaluation of Medical Devices) ([2]). |
| Cleaning and Disinfection Effectiveness | Evaluated and found to conform to applicable medical device safety standards ([2]). |
| Thermal, Electrical, Electromagnetic, and Mechanical Safety | Evaluated and found to conform to applicable medical device safety standards ([2]). Compliance with AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety), IEC60601-1-2 (EMC Requirements), IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring), and ISO14971 (Risk Management) ([2]). |
| Imaging Capabilities, Technological Characteristics, Safety, and Effectiveness for Intended Use | Deemed "substantially equivalent" to predicate devices LOGIQ S7, LOGIQ S8 (K131527), and LOGIQ P6 (K101874) ([1], [2]). This includes the same fundamental scientific technology, clinical intended use (with Transesophageal being equivalent to LOGIQ S8), imaging modes, and similar capabilities for measurements, digital image capturing, reviewing, and reporting studies ([1], [2]). |
| Software Features (AutoEF, Autosweep, Breast Measure Assistant, OB Measure Assistant, Compare Assistant, Preset Manager) | These new software features are "the same features cleared on predicate LOGIQ S8 (K131527)" ([2]). |
Details of the "Study" (Demonstration of Substantial Equivalence):
As no clinical studies were performed, the "study" described in the document is a non-clinical comparison to predicate devices and adherence to recognized standards.
- 1. A table of acceptance criteria and the reported device performance: See the table above. The acceptance criterion is "compliance with standards" and "substantial equivalence" to predicate devices.
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used. The demonstration of safety and effectiveness was based on engineering testing, comparison to predicate devices, and compliance with standards.
- 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No clinical ground truth was established for the purpose of this 510(k) submission.
- 4. Adjudication method for the test set: Not applicable.
- 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 pertains to an ultrasound system, not an AI-assisted diagnostic tool for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an ultrasound imaging system, not a standalone algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical studies were required or performed.
- 8. The sample size for the training set: Not applicable. This device is an ultrasound system, not an AI/ML algorithm that undergoes training in the context of this submission.
- 9. How the ground truth for the training set was established: Not applicable.
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(78 days)
LOGIQ S7 EXPERT, LOGIQ S7 PRO
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); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 7-inch LCD touch screen and color 19-inch LCD image display.
This document is a 510(k) Premarket Notification Summary for the GE Healthcare LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System. It details the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices through non-clinical testing. It explicitly states that clinical studies were NOT required to support substantial equivalence.
Therefore, most of the requested information regarding acceptance criteria derived from a clinical study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone algorithm performance cannot be provided from this document.
Here's the information that can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical studies were performed, there are no specific acceptance criteria for diagnostic accuracy or performance metrics (like sensitivity, specificity, or AUC) that would typically be reported from a clinical study. The acceptance criteria focused on non-clinical aspects and compliance with established standards.
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Acoustic Output | Conforms to applicable medical device safety standards and voluntary standards (NEMA UD 3, NEMA UD 2) |
| Biocompatibility | Conforms to applicable medical device safety standards and voluntary standard (ISO10993-1) |
| Cleaning and Disinfection Effectiveness | Conforms to applicable medical device safety standards |
| Thermal Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Electrical Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Electromagnetic Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Mechanical Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Risk Management | ISO14971 compliant (Application of risk management to medical devices) |
| Digital Imaging and Communications | NEMA, Digital Imaging and Communications in Medicine (DICOM) Set compliant |
| Overall (Substantial Equivalence) | Considered as safe, as effective, and performance is substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable, as no clinical performance testing was conducted.
- Data Provenance: Not applicable, as no clinical data was used for performance evaluation in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "The subject of this premarket submission, LOGIQ S7 Expert and LOGIQ S7 Pro, did not require clinical studies to support substantial equivalence." This device is an ultrasound system, not an AI-powered diagnostic tool, so an MRMC study for AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, a standalone performance study was not done. This device is an ultrasound system and not an algorithm for standalone diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable, as no clinical performance testing requiring ground truth was conducted for this submission. The "ground truth" for this submission was compliance with established safety and performance standards for ultrasound devices, assessed through non-clinical means.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. Training sets are relevant for AI/machine learning models, which are not the subject of this 510(k) submission for an ultrasound system.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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