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510(k) Data Aggregation
(14 days)
ALOKA CO. LTD USA
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial.
Modes of operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler.
Combined (specify): See Below
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD
Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.
The Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 5 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The provided text is a 510(k) summary for the Aloka SSD-Alpha 5 diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Aloka SSD-5500) rather than presenting a performance study with acceptance criteria in the context of a new AI algorithm or a specific diagnostic task.
Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth type for studies) are not present in this document.
The document discusses the device's technical characteristics and intended uses, comparing them to the predicate device to establish substantial equivalence. It does not detail a specific clinical performance study to "prove the device meets acceptance criteria" in the way a novel AI diagnostic device would.
Here's an attempt to address the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria and reported device performance for a specific diagnostic task. The "acceptance criteria" discussed are related to general safety and technical standards for ultrasound devices, and the "performance" is implicitly deemed equivalent to the predicate device.
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output | Below maximum levels allowed by FDA | The SSD-Alpha 5 acoustic power output levels are below the maximum levels allowed by the FDA. |
| Quality Assurance | Subjected to the same Quality Assurance systems as predicate | The SSD-Alpha 5 is subjected to the same Quality Assurance systems in development and production as other products including the SSD-5500. |
| Patient Contact Material Safety | Evaluated for safety via same standards/methods as predicate | The patient contact materials used in the SSD-Alpha 5 have been evaluated for safety via the same standards and methods as the above mentioned product marketed by Aloka. These materials have been found to be safe for their intended uses. |
| Electrical and Physical Safety | Complies with standards as predicate devices | The SSD-Alpha 5 complies with electrical and physical safety standards as other products currently marketed by Aloka such as the: SSD-5500 (K032875). |
| Compliance with Standards (e.g., NEMA-UD2, AIUM, IEC, UL, ISO) | Compliance with specific listed standards | Aloka Co., Ltd. Certifies that the SSD-Alpha 5 complies with NEMA-UD2: 1992, AIUM 1994 "Acoustic Output Labeling Standard", IEC-60601-1 (2001-09 Class A), UL 2601-1, 200 edition (1997), Part 1, 200 edition including Amendments 1&2 and ISO10993-1:1997. All testing will be completed, prior to distribution, to meet the requirements of the standards listed above. |
| Premarket Notification | Submission of postclearance special report with acoustic output measurements | Condition of substantial equivalence is submission of a postclearance special report containing complete information, including acoustic output measurements based on production line devices, and other requested information. |
2. Sample size used for the test set and the data provenance
No specific test set or clinical study data (in terms of patient cases) is mentioned for evaluating the diagnostic performance of the Aloka SSD-Alpha 5. The submission relies on demonstrating substantial equivalence to its predicate device (Aloka SSD-5500) based on similar technological characteristics and intended uses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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 is not an AI diagnostic device, and no MRMC comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No specific ground truth for a diagnostic performance study is mentioned in the context of this 510(k) submission. The device's "ground truth" for its general function is based on its ability to produce images and flow analysis according to established ultrasound physics and engineering principles, and its equivalence to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable.
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(15 days)
ALOKA CO. LTD USA
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.
The Aloka SSD-5500 V6.0 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-5500 V6.0 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The provided text is a 510(k) summary for the Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study performance metrics or acceptance criteria for a novel AI algorithm. Therefore, much of the requested information regarding acceptance criteria and performance against those criteria, as well as specific details about test and training sets, expert qualifications, and comparative effectiveness studies, is not present in this document.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present specific quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the listed predicate devices across various clinical applications and operation modes.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Technological Characteristics | - Uses essentially the same technologies for imaging, Doppler functions, and signal processing as predicate devices (SSD-1700, SSD-5500 V3.1, V4.2, V4.2.2). | This indicates that its fundamental operation and expected performance are on par with established devices. |
| Method of Use | - Has the same method of use as predicate devices. | Ensures similar user interaction and clinical workflow. |
| Acoustic Power Output Levels | - Below the maximum levels allowed by the FDA. | Complies with safety regulations. |
| Quality Assurance | - Subjected to the same Quality Assurance systems in development and production as predicate devices. | Implies adherence to established manufacturing and testing standards for reliability and safety. |
| Patient Contact Materials | - Evaluated for safety via the same standards and methods as predicate devices; found safe for intended uses. | Focuses on biocompatibility and safety for patient contact. |
| Electrical and Physical Safety Standards | - Complies with electrical and physical safety standards (NEMA-UD2: 1992, AIUM 1994, IEC-60601-1, UL 2601-1, ISO10993-1). All testing completed and results meet requirements. | Demonstrates adherence to recognized international safety and performance standards. |
| Indications for Use (with Transducers) | The device, with its various transducers, supports a wide range of clinical applications including: Fetal, Abdominal, Intraoperative (liver, pancreas, gall bladder), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal (Conventional & Superficial). For most applications, the device's capability (B, M, PWD, Color Doppler, Amplitude Doppler) is marked as "P" (previously cleared by FDA) or "E" (added under Appendix E), indicating equivalence to or extension of existing cleared indications. | This is the primary "performance" stated, demonstrating its clinical utility across various body regions and diagnostic modes, consistent with predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state a sample size for a test set or the provenance (country of origin, retrospective/prospective) of any specific data used to evaluate the substantial equivalence from a performance perspective.
- The evaluation appears to be based on a comparison to characteristics and performance of existing legally marketed predicate devices, rather than a new clinical study with a distinct test set for performance metrics. The tables listing "P" (previously cleared by FDA) and "E" (added under Appendix E) suggest that the current device is being compared to the established performance of the predicate device for those indications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the document.
- Given that this is a 510(k) submission asserting substantial equivalence to predicate devices, it's unlikely that new "ground truth" establishment by a panel of experts for a novel device performance study was required or conducted in the manner of a de novo submission. The "ground truth" for the predicate devices' performance would have been established during their initial clearances.
4. Adjudication Method:
- This information is not provided in the document.
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:
- This information is not applicable and therefore not provided. The Aloka SSD-5500 V6.0 is a diagnostic ultrasound system, not an AI-powered image analysis or diagnostic aid designed to be used in conjunction with human readers to improve their performance. It's a standalone imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device being evaluated is a standalone diagnostic ultrasound system. Its performance is inherently "standalone" in the sense that it generates images and Doppler information directly. However, it is not an "algorithm only" device; it's a complete hardware and software system for image acquisition and display. The clinical performance is tied to the images and data it produces, which are then interpreted by a human operator/physician.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of this 510(k) submission, the "ground truth" for the new device's performance is established by demonstrating its substantial equivalence to the performance and characteristics of its predicate devices. The predicate devices themselves would have had their performance (and hence their implicitly "ground-truth-validated" capabilities) established through various means at the time of their clearance, which could have included expert consensus, physical phantom testing, and clinical evaluations. The document does not specify how the predicate devices' performance was originally validated, only that the new device meets those established standards.
8. The Sample Size for the Training Set:
- This information is not applicable and therefore not provided. This device is a traditional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" of data in the sense typically associated with machine learning algorithms.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable and therefore not provided, as the device doesn't rely on a "training set" in the AI/ML context.
In summary:
This 510(k) submission for the Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System primarily demonstrates its substantial equivalence to previously cleared predicate devices by comparing their technological characteristics, methods of use, safety, and indications. It does not contain details about specific clinical studies with distinct acceptance criteria, test/training sets, or expert ground truth establishment as would be expected for a novel AI/ML device. The "proof" the device meets acceptance criteria is fundamentally its demonstrated sameness in key aspects to already cleared devices and adherence to relevant safety standards.
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