(222 days)
The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility.
The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.
Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture.
The SOS measured by MiniOmni has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).
The Sunlight MiniOmni Ultrasound Bone Sonometer is a noninvasive device that consists of:
- Main unit, which contains an ultrasound transmission / reception printed circuit board (1) (ultrasound PCB) and mechanical and electric elements for connecting the ultrasound probes
- (2) User interface and algorithmic calculation software provided in installation disc
- (3) Hand-held probes (choice from 3 ultrasonic probe types already PMA-approved, plus one new probe)
- Medical grade AC to DC power adaptor and cable (4)
- (5) USB Connection cable
- System quality verification (SQV) phantom; (6)
- Spring-loaded positioning gauge; (7)
- (8) Cushioned hand rest
- (a) User Guide
- Ultrasound gel (optional accessory)
- Skin marker pencil (optional accessory)
- Foot pedal (optional accessory) 12)
- Sterile disinfection towelettes (optional accessory) (13)
- Carrying case for easy mobility (optional accessory) (14)
The MiniOmni requires connection to a stand-alone computer and visual display unit provided by the user in order to operate as intended.
The provided 510(k) summary for the BeamMed MiniOmni Bone Sonometer focuses on demonstrating substantial equivalence to a predicate device (Sunlight Omnisense 7000S Bone Sonometer) rather than presenting a standalone study with acceptance criteria and performance data for this new device.
The document explicitly states: "The performance of the MiniOmni is identical to that of the predicate device." Therefore, the "reported device performance" and "study that proves the device meets the acceptance criteria" are based on the predicate device's existing approvals.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Based on Predicate Device) | Reported Device Performance (MiniOmni) |
|---|---|---|
| Indications for Use | Quantitative measurement of signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) at distal one-third of the radius, proximal third phalanx, and fifth metatarsal. SOS provides an estimate of skeletal fragility. Output as T-score & Z-score, usable with clinical risk factors for osteoporosis diagnosis and fracture risk determination. Low precision error for monitoring bone changes post-menopause (age 50-65 years). | Same |
| Measurement Mode | Speed of Sound (SOS) | Same |
| Measurement Precision | 0.40%-0.81% short term in-vivo precision (skeletal site dependent); 0.25%-0.50% instrumental accuracy (probe dependent) | Same |
| Measurement Time | Approximately 1 to 1½ minutes (3 to 5 measurement cycles of approx. 20 seconds each) | Same |
| Algorithms | As described in PMA P990035 (Predicate device's PMA) | Same |
| Calibration | Calibration free; Daily System Quality Verification (SQV) with Phantom is required | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information about a specific test set or sample size for a new study to prove the MiniOmni's performance. The basis for performance claims is the predicate device, the Sunlight Omnisense 7000S, which was approved under PMA P990035. Details regarding the original PMA study's sample size, data provenance, and study design are not included in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not available in the provided 510(k) summary, as it relies on the predicate device's prior approvals and does not describe a new ground truth establishment process for the MiniOmni.
4. Adjudication Method for the Test Set
This information is not available in the provided 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not available in the provided 510(k) summary. The device is a bone sonometer, which measures physical properties, and the submission primarily focuses on hardware and software equivalency, not on AI-driven interpretation or human-in-the-loop performance improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The document states: "The performance of the MiniOmni is identical to that of the predicate device." The predicate device's algorithms were "As described in PMA P990035." It can be inferred that the algorithms for calculating SOS, T-scores, and Z-scores operate in a "standalone" fashion (algorithm only) after the user acquires the ultrasound data. However, a specific standalone performance study for the MiniOmni itself is not detailed. The MiniOmni operates with software on a user-provided computer, meaning the algorithm is separate from the physical measurement unit but still requires human interaction for data acquisition and input.
7. Type of Ground Truth Used
For bone sonometers like the MiniOmni, the "ground truth" for bone health assessment typically involves comparison with established reference standards or correlation with other bone density measurement techniques (e.g., DXA, which is considered a gold standard for bone mineral density). However, the provided document does not specify the type of ground truth used for the predicate device's original PMA, nor for any new evaluation of the MiniOmni. The device provides "an estimate of skeletal fragility" and calculates T-scores and Z-scores based on embedded reference databases, rather than directly measuring pathology or relying solely on outcomes data.
8. Sample Size for the Training Set
This information is not available in the provided 510(k) summary. The device utilizes "an embedded reference database" for T-score and Z-score calculations, which likely represents a "training set" in a broad sense, but its sample size and characteristics are not detailed.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided 510(k) summary. For the "embedded reference database," the ground truth would have been established through a clinical study or compilation of data from a large healthy population and age-matched populations. Details of this process are not included.
§ 892.1180 Bone sonometer.
(a)
Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.