(30 days)
The leva Pelvic 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 Pelvic Health System ("leva System") 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 system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient's mobile device. The leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.
The leva PHS 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 provided text describes a 510(k) premarket notification for the "leva Pelvic Health System." It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K192270, leva Pelvic Digital Health System) based on technological characteristics and non-clinical testing.
Crucially, this document does NOT contain information about a study proving the device meets specific performance acceptance criteria related to its clinical efficacy or accuracy using AI. It mainly discusses hardware, firmware, and software changes, and non-clinical testing (biocompatibility, software/firmware design verification, manufacturing testing). Therefore, I cannot fulfill most of the requested information about acceptance criteria for device performance, clinical study design, expert ground truth, or MRMC studies, as these types of details are not present in the provided 510(k) summary.
The device is a perineometer that provides an indication of the relative intensity of pelvic floor muscle contraction using accelerometers. Its intended use is for strengthening, rehabilitation, and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence.
Here's what can be extracted from the provided text:
-
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement thresholds for a specific clinical outcome). The "acceptance" discussed is related to demonstrating substantial equivalence through non-clinical testing.
- Reported Device Performance: The document states that "Biocompatibility testing demonstrated that the subject device, leva Pelvic Health System, is as safe and effective, and performs as well as the predicate device, leva Pelvic Digital Health System." It also mentions "Software and firmware design verification testing" and "Manufacturing testing protocol verification" were done to ensure the device continues to meet requirements for substantial equivalence. However, specific performance metrics or thresholds are not provided.
-
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document focuses on non-clinical testing (biocompatibility, software verification, manufacturing testing) and does not describe a clinical test set with human subject data.
-
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):
- Not applicable/Not provided. No clinical test set with ground truth established by experts is described in this document.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set requiring adjudication 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:
- No. This document does not describe an AI-assisted device or an MRMC study. The device provides "indication of relative intensity of pelvic floor muscle contraction using accelerometers" and transmits data to a mobile app for user monitoring and guidance. It does not appear to employ AI for diagnostic or assistive interpretation requiring human reader studies.
-
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. The device's primary function is to measure muscle contraction and provide data to the user via an app for rehabilitation purposes, not to provide an automated diagnosis or interpretation in a "standalone" fashion as might be expected from a typical AI algorithm in medical imaging.
-
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not specified/Not applicable to a clinical study. The "ground truth" implicitly referred to is safety and performance equivalence to the predicate device, demonstrated through non-clinical tests (biocompatibility, software/firmware design verification, manufacturing testing).
-
8. The sample size for the training set:
- Not applicable/Not provided. This document does not pertain to the development or validation of an AI model with a training set.
-
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No AI model training set is discussed.
Summary of available information regarding the device itself:
- Trade/Device Name: leva Pelvic Health System
- Regulation Number: 21 CFR §884.1425
- Regulation Name: Perineometer
- Regulatory Class: II
- Product Code: HIR
- Intended Use:
- 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.
- Principle of Operation: Provides indication of relative intensity of pelvic floor muscle contraction using accelerometers.
- Key changes from predicate (minor modifications):
- Hardware (adhesive, PCB/PCBA, battery vendor, labeling)
- Embedded software (firmware: performance improvement, communications, diagnostic, bug fixes)
- Mobile Application Software (bug fixes, content updates like educational videos)
- Manufacturing and Risk Analysis updates
- Testing performed to support substantial equivalence (non-clinical):
- Biocompatibility (ISO 10993-1, -5, -10)
- Software and firmware design verification testing
- Manufacturing testing protocol verification
§ 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).