(27 days)
- . Cataracts
- Retinal Detachments (a separation of the retina from the middle coat of the eyeball) .
- Orbital Lesions .
- Tumors 에
- Foreign bodies .
- . Inflammation
- Vascular Irregularities r
The I SYSTEM-ABD™ is a diagnostic ophthalmic ultrasound instrument designed to be used by ophthalmologists for diagnosis of the eye. It is expected that the user is trained in operation of ophinamogiles for the medical interpretation of ultrasonic images. The intended use is the same for the entire I 'SYSTEM-ABD™ product family.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A and B mode)
The difference between the Version 2 system and the existing 13 SYSTEM-ABD™ Diagnostic Ultrasound system is the operating system on which it runs. The new version has a 32-bit operating system, the current version has a DOS based operating system. No changes have been made to any external accessories or probes.
The information provided in the document K041947 is a 510(k) summary for a modified diagnostic ultrasound system (I3 SYSTEM-ABD™ Diagnostic Ultrasound, Version 2). The purpose of this 510(k) is to indicate substantial equivalence to a predicate device (I3 SYSTEM-ABD™ Diagnostic Ultrasound, Version 1) because the operating system is being updated from DOS-based to a 32-bit Windows-based system. The hardware and external accessories/probes remain the same.
The document discusses Verification and Validation but does not provide specific acceptance criteria or study results demonstrating performance for clinical indications. Instead, it states that "All verification and validation tests have been performed as specified in the Design Controls Procedures (QAP 4.4) in conformance with 21 CFR 820.30. The tests have demonstrated that the unit complies with the intended functional requirements and system specifications." This implies that the focus of the submission is to confirm that the change in operating system does not negatively impact the existing, already-cleared performance of the device.
Therefore, many of the requested details, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods, are not present in this specific 510(k) summary because the submission is for a software update to an already cleared device, not for the initial clearance of a new device with new performance claims.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document implicitly indicates that the acceptance criteria are that the modified device (Version 2) continues to meet the "intended functional requirements and system specifications" (page 1) as established for the predicate device (Version 1). This is a qualitative statement of equivalence for functional compliance after a software update, rather than quantitative performance metrics.
Reported Device Performance:
The document does not provide specific quantitative performance data for clinical indications or diagnostic accuracy for either the predicate or the modified device. The submission’s purpose is to affirm that the change in the operating system does not alter the intended use or performance of the device, which was presumably assessed during the original 510(k) clearance (K902007) for the predicate device.
Table:
Given the information, a table of specific acceptance criteria and reported device performance directly from this document cannot be created as these details are not provided. The critical "performance" stated is that "the unit complies with the intended functional requirements and system specifications" after the software update.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The verification and validation tests mentioned refer to internal Design Controls Procedures (QAP 4.4) (page 1). There is no mention of clinical data or patient studies for this specific 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable/Not specified. This 510(k) does not describe a study involving expert-established ground truth for performance evaluation of clinical indications.
4. Adjudication Method for the Test Set
- Not applicable/Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done as described in this document. This submission focuses on a software update, not a comparative clinical performance study.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable/Not specified. The device is a diagnostic ultrasound system intended for use by ophthalmologists for diagnosis, so it is inherently human-in-the-loop. The submission is not for a standalone algorithm.
7. The Type of Ground Truth Used
- Not applicable/Not specified. No external ground truth data from clinical cases is mentioned as being used for this submission. The validation focuses on functional and system specifications.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This submission is for a software update to an existing device, not for a new algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.