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510(k) Data Aggregation
(33 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Musculo-skeletal Conventional and Musculo-skeletal Superficial. Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
The Fukuda Denshi model UF-4500 (K022208) and the model UF-3500 (K955543) are general-purpose ultrasound systems that have been previously found to be substantially equivalent under the Food and Drug Administration's 510(k) process. These devices have not been changed or modified in any way. All software and hardware, all portions of the device that control the acoustic power out are unchanged. The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions.
The provided text describes a 510(k) submission for adding new intended uses (conventional and superficial musculoskeletal imaging) to existing Fukuda Denshi ultrasound scanners (UF-3500 and UF-4500).
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for diagnostic performance or reported performance metrics in a typical table format. The "Testing" section broadly concludes the device's capability.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Acoustic Output Limits | Remains below maximums established for Track 1 devices by "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 30, 1997). (Specific limits for Peripheral Vessel, Cardiac, Fetal Imaging & Other, Ophthalmic are provided in a table, e.g., ISPTA3 < 190 Mw/CM², MI < 1.9 for Cardiac; ISPTA3 < 28 Mw/CM², MI < 0.23 for Ophthalmic). | The devices' derated acoustic output limits remain below the established maximums. |
| Image Quality | Implicit criteria: Capable of accurately and reproducibly imaging musculoskeletal structures. | "these devises have exhibited the capability of accurately and reproducibly imaging the musculoskeletal structure." |
| Safety and Effectiveness | Device is safe and effective in obtaining conventional and superficial musculoskeletal images. | "Fukuda Denshi has demonstrated through this study that the device is safe and effective in obtaining conventional and superficial musculoskeletal images" |
| Substantial Equivalence | Equivalent to predicate devices (ATL model Level 10 HDI Ultrasound System (K961459) and GE Model LOGIQ 500 (K970901)) for the new intended use. | "is substantially equivalent to the predicate device." |
| Patient Contact Materials | No changes required to patient contact materials for the new intended use. | "Patient contact materials have not changed" |
| Software/Hardware Changes | No changes to hardware or software that control the device or acoustic output are required for the new intended use. | "No changes to the hardware or software that control the device or the acoustic output were required to support the claims for musculoskeletal imaging." |
| Operating Instructions | No changes to operating instructions are required for the new intended use. | "The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Skilled sonographers using both the UF-3500 and the UF-4500 obtained images."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: "a radiologist" (singular, implying one).
- Qualifications of Experts: The expert was a "radiologist." No specific tenure or sub-specialty experience is mentioned (e.g., "10 years of experience").
4. Adjudication Method for the Test Set:
- The document states, "All imaged were reviewed by a radiologist who rendered findings and clinical impression." This implies a single-reader review, not a formal adjudication method (like 2+1 or 3+1). There is no mention of disagreement resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No MRMC study was mentioned. This submission is for an ultrasound scanner being used for new indications, not an AI-powered device or an AI assistance tool for human readers. Therefore, there is no information on human reader improvement with/without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. The device in question is a diagnostic ultrasound scanner that is operated by a sonographer and interpreted by a radiologist. It is not an algorithm-only device. The study described involves human operators and interpreters.
7. The Type of Ground Truth Used:
- The ground truth was established by a "radiologist who rendered findings and clinical impression." This leans towards expert consensus/clinical impression, albeit from a single expert as described. There is no mention of pathology or outcomes data being used as ground truth.
8. The Sample Size for the Training Set:
- Not applicable. The description refers to a study performed to demonstrate the capability of existing ultrasound diagnostic equipment for new intended uses, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for a machine learning model.
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