(92 days)
The leva Pelvic Digital Health System is intended for:
- Strengthening of the pelvic floor muscles;
- Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women.
This device interacts with the user via smart phone technology
The leva-02 PDHS is a prescription intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The leva-02 is designed to wirelessly facilitate pelvic floor muscle training (PFMT) in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded to the patient's mobile device. The levo-02 is designed to be used vaginally and is intended to be used repeatedly by a single patient.
The leva-02 consists of a probe, storage case, associated batteries and the Renovia Digital Health App (App). Thermoplastic elastomer (TPE) was used as the material overlay for the electronics and six accelerometers are contained within the probe. Additional electronics are contained in the storage case to transmit data wirelessly between the device and the App.
The document provided is a 510(k) Summary for the Leva Pelvic Digital Health System (leva-02) and focuses on establishing its substantial equivalence to a predicate device (leva-01). As such, it details non-clinical testing performed to demonstrate this equivalence rather than presenting an exhaustive study of the device's performance against specific acceptance criteria for its intended use.
Therefore, the requested information specifically about acceptance criteria, reported device performance in a table, sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be fully extracted from this document, because the document primarily refers to demonstrating safety and effectiveness compared to an existing device, not a de novo study proving efficacy to specific performance metrics for the intended use directly.
However, I can provide the information that is available and explain what is missing.
Here's an attempt to answer based on the provided text, highlighting what is implicitly or explicitly stated:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of specific clinical acceptance criteria (e.g., minimum percentage improvement in pelvic floor strength, or reduction in incontinence episodes) for the device's intended use, nor does it report the device's performance against such criteria. The "acceptance criteria" mentioned in the document relate to the validation of hardware, software, usability, biocompatibility, electrical safety, and packaging against established standards and internal procedures to show equivalence to the predicate device.
For example, under "Hardware verification," it states "Hardware verification was performed in accordance with predefined test procedures and acceptance criteria and included the following assessments: Dimensional analysis […]. Hardware verification demonstrated that the subject device, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01." This is the general nature of the "reported performance" against "acceptance criteria" presented.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document largely refers to non-clinical testing:
- Hardware, Software, Biocompatibility, Electrical Safety, Packaging: These involve technical tests, not patient-based test sets in the typical clinical sense. Therefore, the concept of sample size for a "test set" and "data provenance" (country/retrospective/prospective) as applies to human subjects is not relevant here.
- Usability: "Usability and Human Factors testing was performed using layperson volunteers." The exact number of layperson volunteers is not specified. The provenance of these volunteers (e.g., country) is also not specified, nor whether the testing was prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not describe a clinical study that involved expert-established ground truth for performance evaluation of the device's intended use. The testing described is primarily engineering and safety-focused.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document does not describe a clinical study involving expert adjudication.
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 type of study is not mentioned in the document. The device is a "Pelvic Digital Health System" working with a smartphone app, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an "intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT)." It "interacts with the user via smart phone technology." This inherently describes a human-in-the-loop system. The document does not describe a standalone algorithm only performance study separate from the user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (hardware, software, biocompatibility, electrical safety, packaging), the "ground truth" would be compliance with specified engineering standards, design specifications, and regulatory requirements (e.g., ISO 10993 for biocompatibility). For usability, the "ground truth" was successful completion of tasks by layperson volunteers. No "clinical ground truth" (expert consensus, pathology, outcomes data) for the device's efficacy in strengthening pelvic floor muscles or treating incontinence is mentioned, as "Clinical testing was not required to support a substantial equivalence determination for the leva-02 PDHS."
8. The sample size for the training set
This document does not describe the development or optimization of an AI algorithm based on a training set. The device uses accelerometers to "provide indication of relative intensity of pelvic floor muscle contraction," which is more akin to a sensor-based measurement system than a machine learning model that would require a "training set" for classification or prediction.
9. How the ground truth for the training set was established
As no training set is discussed, this information is not applicable.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).