(49 days)
MyLabSigma is intended to perform diagnostic general ultrasound studies including:
Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal,
Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional),
Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric,
Transoesophageal (cardiac), Peripheral Vessel.
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.
The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.
Model 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry.
Model 7410 is equipped with wireless capability.
Model 7410 is already cleared via K161359.
The marketing name for new devices of Model 7410 will be:
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MyLabSigma ●
MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below: -
Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
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Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement.
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. Management of probes L3-11, L4-15, mC 3-11 and P2 3-11.
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. Full screen option.
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. Windows 10 Operative System.
The 7410 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that this document is a 510(k) summary for a medical device (ultrasound system), and therefore, the "study" described is a demonstration of substantial equivalence rather than a traditional clinical trial proving specific performance metrics beyond those of predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a quantitative table of acceptance criteria and reported device performance in the way a clinical study might for specific diagnostic metrics. Instead, it asserts substantial equivalence to predicate devices (K161359, K183191, K173291) by demonstrating that:
- The fundamental technological characteristics are the same.
- Clinical uses have not changed or are equivalent to those of previously cleared devices.
- Added options (Auto NT, Auto EF, certain probe management, capacitive touchscreen, full screen mode, Windows 10 OS) are identical or equivalent to features cleared on other Esaote models.
- The device conforms to relevant safety standards.
- Performance (Ergonomics, General Usability, and Image Quality) is in line with predicate and reference devices.
| Acceptance Criteria (Implied / Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Fundamental Technological Characteristics | Same as predicate device Esaote 7410 (K142077, K161359). |
| Clinical Uses | Not changed from 7410 upgrades (K142077, K161359) or equivalent to 7410 model (K161359). |
| Auto NT option | Identical to Esaote 6440 and 6420 models (K173291, K183191). |
| Auto EF option | Identical to Esaote 6440 and 6420 models (K173291, K183191). |
| Probe Management (L 3-11, L4-15, mC 3-11) | Already cleared via K173291. |
| Probe Management (P2 3-11) | Equivalent to SP2442 cleared via K161359 (difference only in connector). Covered by the present submission. |
| Capacitive Touchscreen & Full Screen Mode | Identical to Esaote 6440 and 6420 models (K173291, K183191). |
| Operating System | Windows 10 Enterprise LTSB, identical to Esaote 6440 and 6420 models (K173291, K183191). |
| Acoustic Output, Biocompatibility, Cleaning/Disinfection, Thermal, Electromagnetic, Mechanical Safety | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, ETSI EN 301 489-17 V3.1.1, EN 62479. |
| Ergonomics, General Usability, Image Quality | Test results in line with predicate and reference legally marketed devices; differences have no effect on safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "No clinical tests were performed." Therefore, there is no specific patient-based test set or data provenance to report in this context. The evaluation was based on non-clinical tests (safety, software validation, performance characteristic comparisons).
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 applicable, as no clinical tests were performed and thus no "ground truth" was established from patient data. The ground truth for engineering and system performance would be defined by the relevant standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests were performed.
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 submission is for an ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. The submission focuses on the ultrasound system and its integrated features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on adherence to recognized medical device safety standards (e.g., IEC, NEMA, ETSI standards) and the established performance and safety profiles of the predicate devices. For features like "Auto NT" and "Auto EF," the ground truth is their functional equivalence to previously cleared implementations on other Esaote models.
8. The sample size for the training set
Not applicable, as this is not a machine learning device that requires a training set in the typical sense. The software validation was performed as a part of a system function test.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model was used. Software validation involved testing functions and confirming their operation with traceability of anomalies, likely against predefined functional specifications and requirements.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.