(90 days)
The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient's anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy.
The LymphaTech Mobile 3D Measuring Tool is a standalone software mobile application that uses a high-accuracy off-the-shelf long-wave infrared camera for measuring the diameter, surface area, volume, and circumference of a part of the body. The software allows clinicians to measure body region volume, circumference, surface area, and length with high precision. Specifically, this device uses an off-the-shelf depth sensing scanner, which is a type of long-wave infrared camera, together with an off-the-shelf iPad to acquire complete 3D renderings of the body regions.
The provided document is an FDA 510(k) clearance letter and its associated 510(k) summary for the LymphaTech Mobile 3D Measuring Tool. While it outlines the device's intended use, comparison to a predicate, and types of testing performed, it does not include the specific acceptance criteria or detailed results of the study that proves the device meets those criteria.
Specifically, the document states: "Non-Clinical Bench Performance Testing including linear diameter and length accuracy testing, circumference and surface area testing, volume accuracy testing as compared to water displacement and perometry, and inter-operator variability assessment." However, it does not provide:
- The quantitative acceptance criteria (e.g., "accuracy within X%").
- The reported performance statistics (e.g., "average accuracy of Y% for diameter").
- Details about the sample sizes for the test set, data provenance, ground truth establishment, or multi-reader studies.
Therefore, I cannot fulfill all parts of your request based solely on the provided text. I will answer what can be inferred and explicitly state what information is missing.
Acceptance Criteria and Device Performance
Information Missing: The document states that "Non-Clinical Bench Performance Testing" was conducted, including "linear diameter and length accuracy testing, circumference and surface area testing, volume accuracy testing as compared to water displacement and perometry, and inter-operator variability assessment." However, it does not specify the quantitative acceptance criteria (e.g., a target accuracy percentage or deviation limit) for any of these measurements, nor does it present the reported device performance statistics (e.g., the actual accuracy achieved).
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
Study Details
Here's what can be extracted or inferred about the study performed, with clear notes on missing information:
1. Sample sized used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document mentions "Performance testing of the subject device was conducted on humans," but it does not provide the number of subjects or scans in the test set.
- Data Provenance: The document states "Performance testing of the subject device was conducted on humans." The country of origin is not specified, and it is implied to be a prospective collection of data for the purpose of the study, but this is not explicitly stated.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Note: The document states that "volume accuracy testing as compared to water displacement and perometry" was performed. Water displacement and perometry are objective physical measurement methods often considered 'gold standards' for volume and circumference, rather than requiring expert consensus in the same way, for example, classifying a medical image would.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. Given the nature of the measurements (physical dimensions),, it's more likely that direct comparison to ground truth (water displacement/perometry) would be the primary method for accuracy rather than expert adjudication, but this is not explicitly stated.
4. 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:
- MRMC Study: No, this type of study was not performed or reported. The device is described as an "adjunctive tool to help a qualified health care professional measure and record body part data." The testing description ("inter-operator variability assessment") suggests evaluating consistency among users of the device, rather than comparing human performance with and without device assistance.
- Effect Size: N/A, as an MRMC study comparing human readers with/without AI assistance was not reported.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The "Non-Clinical Bench Performance Testing" described for linear diameter, length, circumference, surface area, and volume accuracy against objective ground truths (water displacement, perometry) represents standalone algorithm performance concerning its measurement capabilities. While a human operates the device, the accuracy of the measurements generated by the software is what's being assessed against physical standards, which is a form of standalone performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for measurement accuracy included water displacement and perometry. These are objective, gold-standard physical measurement techniques.
7. The sample size for the training set:
- Sample Size (Training Set): Not specified. The document describes "Software Verification Testing" but does not detail any machine learning model training or associated training data sets. The device is referred to as "software only."
8. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not specified. As the document doesn't explicitly mention a machine learning component requiring a distinct training set, this information is not provided. The software's core function is to construct a 3D model and perform geometric calculations; the accuracy of these calculations is what the bench testing verifies against physical ground truths.
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.