Search Results

The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

Device Description

The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penrith Elettra Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K100598) is a premarket notification for a diagnostic ultrasound system. For this type of device, the primary "acceptance criteria" for clearance through the 510(k) pathway is demonstrating substantial equivalence to a predicate device. This means the device is as safe and effective as a legally marketed device.

Therefore, the acceptance criteria are implicit:

The device must perform in a manner substantially equivalent to predicate devices.
The device must meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning, disinfection, sterilization, thermal, electrical, mechanical safety, and electromagnetic compatibility.
All claimed indications for use must be covered by the predicate devices.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance
Substantial Equivalence to Predicate Devices:	"The Penrith Elettra system and transducers function in a manner that is substantially equivalent to the previously cleared devices: Acuson Sequoia (K022567), the Acuson Cypress (K052331), and the Philips Avalon CTS (K023931)."
Functional Equivalence (Imaging & Fluid Flow)	"[Elettra and predicate devices] transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. The Elettra and the predicate devices share basic scanning modalities."
Measurement Capabilities	"Some or all predicate device systems allow for measurements of structures and flow, and calculations." (The Elettra is implied to have comparable capabilities given the claim of substantial equivalence and shared modalities.)
Acoustic Output Compliance (Track 3 method)	"Some or all predicate devices and the Elettra follow the Track 3 method for acoustic output."
Biocompatibility	"Patient contact materials used in the Elettra are used in equivalent formulations in the predicate devices."
Safety & Compliance with Standards	"The Penrith Elettra has been evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility. It has been found to conform with applicable medical device safety standards."
Indications for Use	"All indications for use claimed for the Elettra are cleared indications found on some or all of the predicate devices." (Detailed in pages 4-8, with 'N' (New) referring to new to that transducer, but equivalent to modes on predicate devices).

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) premarket notification for an ultrasound system, which primarily relies on demonstrating substantial equivalence to predicate devices, rather than a clinical study comparing the device to a "gold standard" or a control group.

No specific "test set" sample size is mentioned in the document for performance comparison in a clinical trial sense. The evaluation for substantial equivalence is based on technical, functional, and safety comparisons to already cleared devices.
Data provenance: Not applicable in the context of a prospective clinical "test set" as none is detailed. The performance claims are backed by adherence to standards and comparison of specifications to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a clinical study involving a test set with expert-established ground truth. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices and the adherence to relevant medical device standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set and no expert adjudication process are described in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention any MRMC comparative effectiveness study. This type of study is more common for AI/CADe devices that assist human readers in interpretation. The Penrith Elettra is a diagnostic imaging system itself, not an AI interpretation tool.

6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop) Was Done

Not applicable. The Penrith Elettra is a diagnostic ultrasound system, not an AI algorithm. Its "standalone performance" is its ability to generate images and perform measurements, which is assessed through technical evaluation and comparison to predicate devices, rather than a specific algorithm-only study. The document states it was "evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility."

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" is primarily:
- The established safety and effectiveness of the identified predicate devices (Acuson Sequoia K022567, Acuson Cypress K052331, Philips Avalon CTS K023931).
- Compliance with recognized medical device safety and performance standards (e.g., Track 3 method for acoustic output, electrical/physical safety standards).

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set is involved for this device, there is no ground truth establishment for a training set.

In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. It demonstrates safety and effectiveness by establishing substantial equivalence to existing, legally marketed predicate devices through technical comparisons, adherence to standards, and matching indications for use. It does not involve a clinical study with specific test sets, expert ground truth development, or AI algorithm performance evaluation the way a more modern AI/CADe submission might.

Ask a Question

Ask a specific question about this device

Page 1 of 1