(32 days)
Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, A bdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).
The MyLab15/20 is a compact console ultrasound system used to perform general The WYLao is a coulies. Its primary modes of operation are: B-Mode, M-Mode, PW Glaghoone and Color Flow Mapping and Tissue Enhancement Imaging (TEI). Dopper and Color 110 mages and time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images
The provided 510(k) summary for the MyLab15/20 Just3D/4D Ultrasound System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study with specific metrics.
Therefore, the document does not contain the acceptance criteria and the results of a study designed to prove the device meets those criteria.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria Defined: The document does not explicitly state any numerical or qualitative "acceptance criteria" against which the device's performance is measured. Instead, it relies on comparison to predicate devices to establish substantial equivalence.
- No Performance Study Reported: There is no description of a dedicated study (clinical or analytical) designed to evaluate the device's performance against specific metrics. The tables provided are for "Comparison Chart for Substantial Equivalence" and "Indications for Use," which list features and approved applications, not performance results.
- Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not ordinarily require a separate, hypothesis-driven performance study with pre-defined acceptance criteria.
Therefore, the bulk of the requested information (points 1-9) cannot be answered from the given text.
I can provide the information that is present in the document which touches upon aspects of equivalence:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The implicit acceptance criterion is "substantial equivalence" to the listed predicate devices in terms of intended use and technological characteristics, as determined by the FDA.
- Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, resolution) are reported in the document. The performance is implied to be equivalent to the predicate devices.
| Feature / Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (MyLab15/20 Just3D/4D) |
|---|---|---|
| General Characteristics | Substantially equivalent to predicate devices (K014168, K043588, K043455, K040060) | |
| Fetal Application | Yes | Yes |
| Abdominal Application | Yes | Yes |
| Pediatric Application | Yes | Yes |
| Small Organ Application | Yes | Yes |
| Neonatal Cephalic Application | Yes | Yes |
| Cardiac Application | Yes | Yes |
| Transrectal Application | Yes | Yes |
| Transvaginal Application | Yes | Yes |
| Peripheral Vascular Application | Yes | Yes |
| Musculo-skeletal Application | Yes | Yes |
| Transducer Type | ||
| Linear | Yes | Yes |
| Convex | Yes | Yes |
| Phased array | No | No (Unlike some predicates which have it) |
| 2D Freq MHz | Comparable range | 2.7 - 15 (Predicates range 1-20 MHz) |
| Multifrequency | Yes | Yes |
| Special Probes | Similar functionality | Endocavity, Mechanically Driven 3D Convex Array |
| Biopsy attachments: Convex | Yes | Yes |
| Biopsy attachments: Linear | Yes | Yes |
| Imaging Modes | ||
| Real Time 2D | Yes | Yes |
| M-mode | Yes | Yes |
| PW Doppler | Yes | Yes |
| CW Doppler | No | No (Unlike some predicates which have it) |
| CFM Doppler | Yes | Yes |
| Amplitude Doppler | Yes | Yes |
| Triplex | Yes | Yes |
| 3D/4D | Yes | Yes (includes Just3D and Just4D) |
| Monitor size (inches) | Comparable | 15" CRT / 15" LCD |
| ECG | Optional | Optional |
| Digital archival capabilities | Yes | Yes |
| VCR & Video printers | Yes | Yes |
| M&A capabilities | Yes | Yes |
| Safety | ||
| Electrical safety | EN60601-1 | EN60601-1 |
Regarding the study aspects:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. This document does not describe a performance study with a test set.
- 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 mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. This device is an ultrasound system with 3D/4D imaging, not specifically an AI-powered diagnostic tool in the sense of current AI submissions (which would typically involve MRMC studies).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an imaging system, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Additional relevant information from the document:
- Device Name: MyLab15/20 - Just3D and Just 4D Ultrasound System
- Manufacturer: Pie Medical (represented by Carri Graham, Official Correspondent)
- Date of Submission: November 10, 2005 (Received: November 15, 2005)
- FDA Clearance Date: December 16, 2005
- Predicate Devices:
- Intended Uses (MyLab15/MyLab20): Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).
- New Indications (N): The submission introduces new indications for various transducers and applications. For example, the BC432P transducer supports new indications (N) for Fetal, Abdominal, and Pediatric applications across B, M, PW, Color Doppler, Amplitude Doppler, and combined modes, including N[2] for Tissue Enhancement Imaging (TEI), N[3] for 3D Imaging, and N[4] for 4D Imaging. This is how the 3D/4D capability is being introduced and cleared.
Acoustic Output Post-Clearance: The FDA letter (page 5) requires a post-clearance special report detailing acoustic output measurements based on production units. This is a common requirement for ultrasonic systems to ensure safety, but it's not a pre-market performance study for diagnostic accuracy.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for an ultrasound system, not a report on a performance study against specific acceptance criteria.
§ 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.