Search Results

The leva Pelvic Digital Health System is intended for:

1. Strengthening of the pelvic floor muscles;
2. Rehabilitation and training of weak pelvic floor muscles for the treatment of stress. mixed and mild to moderate urgency urinary incontinence in women.
   This device interacts with the user via smart phone technology.

The leva Pelvic Digital Health System (leva PDHS) is specifically designed to facilitate pelvic floor exercise training to strengthen pelvic floor muscles and for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women. The leva PDHS is intended to be used repeatedly by a single patient. The device is designed to be used vaginally.
The hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering which isolates the motion electronics from the environment. The leva PDHS uses an app to connect via smart phone. This enables the user to visualize the Kegel exercise she is being trained on.

The provided text is a 510(k) summary for the leva Pelvic Digital Health System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a new standalone study to prove performance against specific acceptance criteria. Therefore, much of the information typically requested for a study proving device performance (like sample size for test sets, ground truth establishment, MRMC studies, or training set details for AI) is not present or applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the device leverages a previous 510(k) clearance (K133990) for the predicate device, "leva Rehabilitative Positional Device." The core technology has not changed, and the current submission primarily modifies the indications for use without requiring additional supporting performance data from user studies.

The "acceptance criteria" presented are primarily conformity to existing standards and specifications, rather than quantitative performance metrics from a new clinical study.

• Cable and vaginal device withstand pulling for over 1,460 cycles: Tested successfully
• Device cleaning for over 1,460 times: Tested successfully
• Device bending (+/-20°) for over 1,460 cycles: Tested successfully |
  | Biocompatibility | Compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10). | Patient contacting material subjected to biocompatibility testing and found compliant. |
  | Software Validation | Software validation performs adequately with no outstanding anomalies, in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (minor software level of concern). | Software validation performed and completed with no outstanding anomalies. |
  | Electrical Safety & EMC | Conformity to IEC 60601-1:2005 (3rd Ed.), IEC 60601-1-2:2007, and IEC 60601-1-11. | Device tested and found to conform to these standards. |
  | Packaging Testing | Adequately protect the device during shipping and storage, conforming to ISTA 2A-2011 "Partial Simulation Performance Test Procedure for Packaged Products 150 lb (68 kg) or Less" (Atmospheric Preconditioning, Atmospheric Conditioning, Compression, Initial Random Vibration, Impacts, Final Random Vibration). | Packaging tested according to ISTA 2A-2011 protocol and found to adequately protect the device. |
  | Usability Testing | Lay volunteers successfully complete tasks including reading instructions, setup, correct use, performing mock Kegel, interpreting UI, cleaning, storage, and disposal. | All participants successfully completed all tests. |
  | Clinical Performance | (Not explicitly defined for this 510(k) as the submission primarily relies on equivalence to predicate and non-clinical data inherited from K133990 for the existing technology). | Not Applicable: The document states "Summary of Clinical Testing: Not Applicable." The basis for clinical effectiveness relies on the predicate device's prior clearance and the fact that the technology fundamentally has not changed. The expanded indications ("Strengthening of the pelvic floor muscles") are considered supported by the existing technology and equivalent properties. |

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size:
  • For hardware verification, biocompatibility, electrical safety, and packaging, the 'sample size' refers to the number of units or materials tested in labs. Specific numbers are not provided, only that "the device was subjected to testing" and "patient contacting material was subjected to biocompatibility testing."
  • For Usability Testing: The document mentions "lay volunteers." The exact number is not specified.
• Data Provenance: The data primarily comes from non-clinical testing (bench testing, lab testing) performed to verify conformity to specifications and standards. This is likely internal testing by Remendium Labs, LLC (the original manufacturer of the predicate) and Renovia Inc.
  • The data from the predicate device (K133990) is leveraged, indicating its provenance would be similar.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This type of detail is not provided in a 510(k) summary focused on substantial equivalence and non-clinical testing. Ground truth (e.g., for diagnostic accuracy) is not established through expert consensus in this context because the device is a therapeutic/training device, not a diagnostic one that produces "diagnoses" requiring expert validation.
• The closest to "expert" input would be the engineers and quality assurance personnel who designed and verified the device against engineering specifications and relevant standards.

4. Adjudication method for the test set:

• Not applicable for this type of submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret images or data, and their interpretations need to be reconciled to establish a ground truth or resolve disagreements. Here, the testing is against predefined engineering and regulatory standards.

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, an MRMC comparative effectiveness study was not done. This device is a pelvic floor muscle exerciser and training system. It's a therapeutic device for muscle rehabilitation, not an AI-assisted diagnostic tool that would be evaluated for its impact on human reader performance. Its function is to provide biofeedback and guidance for exercise, not to assist in interpreting clinical data that humans typically read.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This concept is not directly applicable. The device provides biofeedback on muscle contraction. It functions "stand-alone" in the sense that the user interacts directly with the device via a smartphone app to visualize their Kegel exercises. However, it's not an "algorithm" in the typical AI sense that processes data to produce a medical conclusion without human intervention. The "human-in-the-loop" is the user performing the exercises.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical testing, the "ground truth" is defined by engineering specifications, regulatory standards, and established test protocols. For example:
  • For pull or bend cycles: The ground truth is the specified number of cycles the device must withstand without failure.
  • For biocompatibility: The ground truth is compliance with the ISO 10993 series of standards.
  • For electrical safety: The ground truth is conformity to IEC 60601 standards.
  • For usability: The ground truth is the successful completion of specified tasks by lay volunteers.
• No clinical "ground truth" (like pathology or clinical outcomes data from a new trial) was presented in this 510(k) summary as the current submission relies on the predicate's prior clearance and the inherent nature of the technology.

8. The sample size for the training set:

• Not applicable. This device description does not involve a "training set" in the context of machine learning, AI, or diagnostic algorithm development. Its function is based on accelerometers providing biofeedback, not on a trained AI model.

9. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" for an AI model mentioned in the document.

Ask a specific question about this device