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510(k) Data Aggregation
(15 days)
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system 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 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Multi View (MView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.
The provided document is a 510(k) summary for the Esaote 7340 Ultrasound System, submitted to the FDA in 2008. It primarily details the device's intended use and compares its technological characteristics to predicate devices for demonstrating substantial equivalence.
Crucially, this document does NOT contain information about specific acceptance criteria, studies proving device performance against those criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or the type of ground truth used.
The tables within the document (pages 8-10, 15-16) list the clinical applications and modes of operation available on the 7340 system and its predicate devices, as well as for various transducers. The 'N' and 'P' in these tables indicate whether a particular clinical application and mode is 'New' (first introduced with this device for that application) or 'Previously cleared' (using transducers approved in prior submissions) for the specific transducer being discussed. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.
Therefore, I cannot provide the requested information from this document. The sections you asked for are typically found in detailed performance studies, clinical trials, or validation reports, which are not included in this 510(k) summary.
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(19 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
The 7350 is a mainframe ultrasound system used to perform diagnostic general The 7500 is a first framimary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 7350 is equipped with a CRT Color Display. The full alphanumeric keyboard (1121). The plete on-screen data entry of patient information and on-screen annotations. The 7350 can drive phased (PA), convex (CA) and linear array (LA) probes. The 7350 is equipped with a CD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the 7350 include an S-VHS video recorder; a monochrome or color page printer. The 7350 is equipped with an isolation transformer to adequately insulate the system's peripherals.
Here's an analysis of the acceptance criteria and study information for the Esaote 7350 Ultrasound Imaging System (K050326), based on the provided 510(k) summary:
This 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than providing detailed clinical study results with specific performance metrics and acceptance criteria in the way a novel AI/CADe device submission might. Therefore, many of the requested fields will be marked as "Not Applicable" or "Not Provided" based on the content. The acceptance criteria here largely refer to meeting the same technological characteristics and intended uses as the predicate devices, and demonstrating safety and effectiveness as an ultrasound imaging system.
Acceptance Criteria and Device Performance for Esaote 7350 Ultrasound Imaging System (K050326)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate device characteristics and safety standards) | Reported Device Performance (Esaote 7350) |
|---|---|
| Electrical Safety: Compliance with IEC60601-1 | Complies with IEC60601-1 |
| Ultrasound Safety: Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Intended Use Equivalence: Covers specified clinical applications | Covers all specified clinical applications (Cardiac, Fetal, Abdominal, Pediatric, etc.) |
| (See detailed list of "new indications" and previously cleared indications in the document) | |
| Probe Technology Equivalence: Supports Phased Array, Linear Array, Convex Array | Supports Phased Array, Linear Array, Convex Array |
| Operating Modes Equivalence: Supports 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI | Supports 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI |
| Imaging Frequencies Equivalence: Supports 2.0-10 MHz | Supports 2.0, 2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies Equivalence: Supports specified range | Supports 2.0, 2.5, 3.3, 5.0, 6.6, 8.0 MHz (broader than some predicates) |
| Tissue Velocity Mapping feature: If present in predicate, expected here | YES (present, similar to 7300, but not Megas) |
| Biopsy Guidance Equivalence: Supports specified uses and markers | Supports General Purpose, Transrectal, Transvaginal with 1 cm line depth marker |
| Display Characteristics Equivalence: SVGA standard | SVGA standard (uses CRT vs. LCD on 7300, but still SVGA) |
| Digital Archival Capabilities: YES | YES (CD-RW, LAN port, DICOM classes) |
| VCR / Page Printer Support: YES | YES |
| M&A Capabilities Equivalence: Cardiac, Vascular, OB, general purpose | Cardiac, Vascular, OB, general purpose measurements |
2. Sample Size Used for the Test Set and Data Provenance
The provided document is a 510(k) summary for an ultrasound imaging system. It primarily establishes substantial equivalence based on technical specifications and intended uses compared to predicate devices. It does not contain information about a clinical test set with patient data (images) in the way that an AI/CADe device submission would. The "performance" assessment here relates to the system's ability to operate according to its specifications and perform the listed imaging modes for various clinical applications, which is typically verified through engineering testing, compliance with standards, and comparison to existing cleared devices.
Therefore:
- Sample Size for Test Set: Not applicable or not provided. This type of device typically undergoes extensive bench testing, phantom studies, and possibly limited clinical evaluations for image quality and functionality, but not a "test set" of patient data for diagnostic accuracy in the context of AI.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable or not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for an ultrasound system of this nature is its ability to produce diagnostically acceptable images for various applications and its compliance with safety and performance standards. This is assessed through technical verification and validation, not by expert interpretation of a specific test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of an adjudication process for a test set of images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is a submission for a general ultrasound imaging system, not an AI/CADe tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or expected for this type of device.
- Effect size of human readers improving with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Not applicable. This device is an imaging system, not an algorithm, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this type of device, the "ground truth" is derived from:
- Technical Specifications and Standards Compliance: Meeting electromagnetic compatibility, acoustic output limits (IEC60601-1, Track 3 Acoustic Output Display), and electrical safety standards.
- Predicate Device Equivalence: Demonstrating that the new device has substantially equivalent technological characteristics and intended uses to previously cleared (predicate) ultrasound systems.
- Image Quality Assessment: Verification that the system produces images of diagnostic quality across its intended applications and modes, likely through phantom studies and internal clinical evaluation by ultrasound specialists, but without a formal external "ground truth" per se in the context of a diagnostic accuracy study.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/CADe device that relies on a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established (for Training Set): Not applicable.
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