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510(k) Data Aggregation
(27 days)
GE LOGIQ 5 PRO OR EXPERT
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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; and Intraoperative (abdominal, thoracic, vascular and neurological).
The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system available in Expert (full featured) or Pro (reduced feature) versions consists of a mobile console approximately 52 cm wide. 99 cm deep and 135 cm high that provides digital image acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification adds coded pulse modes from high-end LOGIQ systems to the Expert version and removes provides limited options for the Pro version.
The provided document is a 510(k) premarket notification for the GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound System, which was filed in 2003. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study as would be required for novel devices or those with significant changes in indications for use.
Therefore, the document does not contain information related to acceptance criteria or clinical studies designed to prove device performance in the way a modern AI/ML device submission would. Instead, it focuses on demonstrating that the new ultrasound system is as safe and effective as its predicate device.
Here's why the requested information is absent and what the document does provide:
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A table of acceptance criteria and the reported device performance: This is not present. The submission is not structured around demonstrating performance against predefined metrics in a clinical trial. The "performance" assessment is based on comparison to the predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance from a clinical study for performance evaluation is mentioned because no such clinical study was required for this 510(k) submission.
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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): No ground truth establishment or expert involvement for performance validation is described, as it was not required for this type of submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no clinical test set for performance validation.
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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 is an ultrasound imaging system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for performance evaluation was established.
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The sample size for the training set: Not applicable, as this is not an AI/ML device relying on a training set.
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How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
What the document does describe as proof of safety and effectiveness:
The submission relies on demonstrating substantial equivalence to an already legally marketed device (the GE LOGIQ 5 diagnostic ultrasound system, K014097). This is a common pathway for medical devices that are similar to existing ones.
The "proof" in this context is outlined in Section b):
- Non-clinical Tests: The device was evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, and mechanical safety
- It was found to conform with applicable medical device safety standards.
- Clinical Tests: "None required." This explicitly states that no clinical trials were deemed necessary by the FDA for this particular 510(k) submission, precisely because it was being cleared based on substantial equivalence.
- Conclusion: GE Medical Systems asserts that the GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound is substantially equivalent to devices currently cleared for market based on:
- Consistent intended uses and other key features with traditional clinical practice, FDA guidelines, and established methods of patient examination.
- Conformity of the design and development process with 21 CFR 820, ISO 9001, and EN 46001 quality systems.
- Compliance with applicable medical device safety standards, verified through independent evaluation and ongoing factory surveillance.
- The long history of safe and effective performance of diagnostic ultrasound in general.
In summary, this document reflects a regulatory submission from 2003 for an ultrasound system, not an AI/ML device. Therefore, the detailed performance criteria and study design elements typically associated with AI/ML device validation are not present. Instead, "proof" of acceptance is based on compliance with manufacturing standards, non-clinical safety testing, and substantial equivalence to a predicate device already on the market.
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(29 days)
GE LOGIQ 5
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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; and Intraoperative (abdominal, thoracic, vascular and neurological).
The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 52 cm wide, 99 cm deep and 135 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification makes a system with numerous high quality features available to diagnostic ultrasound users in a lower market segment.
GE Medical Systems' LOGIQ 5 Ultrasound System (K014097) is a diagnostic ultrasound system intended for various clinical applications. The submission states that "Clinical Tests: None required." This indicates that no specific clinical study was performed or considered necessary to prove the device meets acceptance criteria, beyond non-clinical testing and comparison to an already-marketed predicate device. Therefore, much of the requested information regarding clinical studies, sample sizes, expert ground truth, and adjudication methods is not applicable based on the provided document.
The acceptance criteria for this device appear to be primarily based on substantial equivalence to a predicate device, the GE LOGIQ 7 diagnostic ultrasound system (K010329), and adherence to various safety and quality standards.
Here's an attempt to fill in the table and address other points based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (GE LOGIQ 7, K010329) | "The GE LOGIQ 5 is of a comparable type and substantially equivalent to the current GE LOGIQ 7. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device." |
| Conformance with Applicable Medical Device Safety Standards | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." |
| Consistency with Traditional Clinical Practice, FDA Guidelines, and Established Patient Examination Methods | "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination." |
| Conformance with Quality Systems | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems." |
| Safe and Effective Performance (Historical Context) | "Diagnostic ultrasound has accumulated a long history of safe and effective performance." |
| Functional Equivalence across various Clinical Applications and Modes of Operation (as detailed in Indications for Use forms for each transducer) | For each listed clinical application (e.g., Fetal, Abdominal, Cardiac, Small Organ) and mode of operation (B, M, PW Doppler, Color Doppler, etc.), the device is indicated to perform (marked 'P' for "previously cleared by FDA"). The specific performance metrics for these applications are not quantified in this document. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable, as no clinical performance study with a test set was conducted. The assessment was based on substantial equivalence and non-clinical testing.
- Data Provenance: Not applicable for a clinical test set. Non-clinical test data would originate from internal GE Medical Systems testing or certified external labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical test set requiring expert ground truth was used for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was used.
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 device is a diagnostic ultrasound system, not an AI-powered diagnostic aide. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a hardware diagnostic ultrasound system, not an algorithm, and no standalone performance study was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for a clinical performance study. The primary "ground truth" for demonstrating substantial equivalence was the predicate device (GE LOGIQ 7) and its established performance characteristics and safety profile, along with adherence to recognized safety and quality standards for ultrasound devices.
8. The sample size for the training set
- Not applicable, as the device is a hardware system, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as the device is a hardware system, not an AI/ML algorithm requiring a training set.
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(30 days)
GE LOGIQ 500
The LOGIQ 500 with Harmonic Imaging is a general purpose utrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal, pediatric, small organ, cephalic, cardiac, transesophageal, transvaginal, peripheral vascular, intra-operative, neurological, and musculo-skeletal.
The LOGIQ 500 with Harmonic Imaging is a mobile console approximately 53 cm wide, 94 cm deep and 130 cm high equipped with a keyboard control panel, small A/N display panel, color video display monitor, assorted transducers and optional image storage or hard-copy devices. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics and contrast media.
Here’s an analysis of the acceptance criteria and study information based on the provided text, using the specified format.
GE LOGIQ 500 with Harmonic Imaging Modification
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety: | The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. A postclearance special report containing complete information, including acoustic output measurements based on production line devices, is required to be submitted to the FDA. |
| Effectiveness: | Harmonic imaging is implemented with conventional digital image processing technology. Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The device is considered substantially equivalent to the currently marketed GE LOGIQ 500 (predicate device) in terms of technological characteristics, key safety and effectiveness features, design, construction, materials, intended uses, operating modes, and transducers. The indications for use for the LOGIQ 500 with Harmonic Imaging are consistent with those previously cleared for the LOGIQ 500, with specific additions for certain transducers (S222, S317, and C358) across various clinical applications and modes of operation (e.g., Abdominal, Adult Cephalic, Cardiac, Other for S222; Abdominal, Cardiac for S317). |
| Quality System: | The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & EN 46001 quality system standards. |
| **Substantial ** | The GE LOGIQ 500 with Harmonic Imaging is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 500. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses, operating modes and transducers as the predicate device. Diagnostic ultrasound has accumulated a long history of safe and effective performance. The FDA reviewed the 510(k) and determined the device is substantially equivalent for the indications for use stated to legally marketed predicate devices. Key transducers (C358, S317, S222) were also determined to be substantially equivalent for their described uses. |
| Equivalence: |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission states "Clinical Tests: None required." The assessment for this device was based on non-clinical tests (acoustic output, biocompatibility, thermal, electrical, and mechanical safety) and a comparison to a predicate device.
- Data Provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set was used.
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 MRMC comparative effectiveness study was done. This device is an ultrasound system with a "Harmonic Imaging" modification, not an AI-assisted diagnostic tool.
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 an algorithm, and its performance inherently involves a human operator for image acquisition and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical ground truth was established or used for performance evaluation in this 510(k) submission. The primary ground for acceptance was substantial equivalence to a predicate device and compliance with safety standards.
8. The sample size for the training set:
- Not applicable, as this is an ultrasound system and not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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(286 days)
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
LOGIQ 500 is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical
The LOGIQ 500 diagnostic ultrasound system with the described modifications is intended for general radiological and cardiac use and consists of a mobile console and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.
The provided 510(k) summary for the GE LOGIQ 500 Diagnostic Ultrasound System is a submission intended to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria.
Therefore, the document does not contain explicit acceptance criteria or a study designed to prove the device meets such criteria. Instead, it relies on the concept of substantial equivalence to already cleared devices.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission.
This document describes a device seeking clearance based on substantial equivalence, not a device establishing new performance claims that require specific acceptance criteria and a detailed performance study against those criteria. The "performance" reported primarily relates to compliance with safety standards and functional equivalence to predicate devices, rather than quantitative clinical performance metrics.
The "Summary of Studies" section vaguely states: "The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." This implies the acceptance criteria are adherence to these established safety standards, but no specific numerical performance metrics are provided.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable.
There is no mention of a "test set" in the context of clinical performance evaluation. The submission focuses on technical specifications, safety compliance, and comparison to predicate devices, not on a clinical test set for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable.
As there is no described test set for clinical performance evaluation, there is no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable.
Without a test set and ground truth establishment, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable.
This submission is for a diagnostic ultrasound system, not an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
This submission is for a diagnostic ultrasound system, not an algorithm.
7. The Type of Ground Truth Used
Not applicable (in the sense of clinical performance ground truth).
The "ground truth" implied in this submission relates to:
- Compliance with safety standards: The "truth" is whether the device meets the specified technical requirements of applicable medical device safety standards.
- Substantial equivalence: The "truth" is whether the device is comparable in safety and effectiveness to the identified predicate devices (ATL HDI 3000 and GE Medical Systems LOGIQ 500).
8. The Sample Size for the Training Set
Not applicable.
This submission describes a diagnostic ultrasound system, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As there is no training set mentioned, no ground truth establishment for it is described.
In summary, the provided document for the GE LOGIQ 500 Diagnostic Ultrasound System is a 510(k) summary relying on substantial equivalence, and therefore does not include detailed clinical performance studies with acceptance criteria, test sets, or ground truth as would be seen for novel devices making specific diagnostic claims, especially those involving AI/ML components. The primary "study" mentioned is the evaluation against existing safety standards, and the "acceptance criterion" is conformance to those standards, alongside demonstrating equivalence to predicate devices.
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