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The Rhea Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.

The Rhea Cup is a reusable menstrual cup placed in the vagina to collect blood and cervical debris that is extruded from the uterus via the cervix during menstruation. The Rhea Cup will be made in two model sizes to allow for the variability of the female vagina and menstrual flow due to normal differences between women as well as the effects of childbirth. Model 1 holds approximately 25ml of fluid and is for women who have never given birth vaginally. Model 2 holds approximately 30ml of fluid and is for women who have given birth vaginally.

The Rhea Cup is made of a flexible silicone elastomer which allows for easy insertion and a comfortable fit in the body. This material is durable and allows the cup to be used during many menstrual cycles. The Rhea Cup is comprised of a body, which acts as a receptacle for fluid and a ribbed tail attached at the base of the body, providing support when removing the cup from the vagina.

The Rhea Cup is made of a silicone elastomer, which has been cleared by the FDA for use in the BelleCup (K092985) predicate device.

This 510(k) submission for the Rhea Cup does not contain the specific information required to complete your request for acceptance criteria and a study that proves the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The provided document is a 510(k) summary and a clearance letter. It focuses on demonstrating substantial equivalence to predicate devices based on material, intended use, and general characteristics. It does not include a table of acceptance criteria for specific performance metrics (e.g., leakage rates, comfort levels, fluid capacity in a real-world setting) nor does it report the Rhea Cup's performance against such criteria from a clinical or non-clinical study.
• No Description of a Performance Study: The document mentions that "No applicable mandatory performance standards or special controls exist for this device," which further indicates that a specific performance study against pre-defined acceptance criteria was likely not a requirement for this 510(k) clearance. Clinical data is often not required for devices cleared through the 510(k) pathway if substantial equivalence can be shown through other means (e.g., material safety data, comparison of characteristics).
• Focus on Substantial Equivalence: The entire submission hinges on comparing the Rhea Cup to predicate devices (Tassaway, BelleCup, Lunette) and arguing that it is "substantially equivalent" in materials, technological characteristics, and intended use. This is the primary "proof" for 510(k) clearance, rather than a direct performance study of the new device against acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

The document fundamentally states that due to substantial equivalence with already cleared devices, no specific performance criteria or studies were needed beyond material compatibility. The "study" proving the device met "acceptance criteria" (which aren't explicitly stated for this new device in the context of performance) was the comparison to predicate devices, demonstrating equivalence.

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The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.

Apex's Solace Post-Operative Pain Relief Infusion System is a single use infusion device, which incorporates an elastomeric bladder with a permanently attached fixed flow rate administration set designed to deliver medication at a constant flow rate. The medication enters the body via a catheter, which is inserted near a surgical wound site then positioned under the skin. The pump attaches to the catheter at the distal end of the administration set. The catheter consists of four design options (same as predicate devices).

The provided text is a 510(k) Premarket Notification for the Solace Post-Operative Pain Relief Infusion System, an elastomeric infusion pump. This type of regulatory submission focuses on demonstrating substantial equivalence to already marketed devices, rather than conducting new clinical trials with acceptance criteria and studies demonstrating device performance against those criteria.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document details the device description, intended use, and technological characteristics, comparing them to predicate devices like the Baxter Infusor and I-Flow Pump to establish substantial equivalence. The key performance metric mentioned is flow accuracy:

• The Solace pump utilizes flow restrictive tubing to achieve +/-15% flow accuracy over the infusion system.
• The I-Flow pump utilizes a glass capillary and/or flow restrictive tubing to achieve +/- 15% flow accuracy over the infusion system.
• The Baxter pump utilizes a glass capillary to achieve +/- 10% flow accuracy over the infusion system.

However, this is a description of the design goal and a comparison point, not a report of a specific study demonstrating that the device meets an acceptance criterion through empirical testing described in this document. The 510(k) process typically relies on bench testing and comparisons to predicate devices for such performance claims, but the detailed study results are not present here.

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