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510(k) Data Aggregation
(90 days)
THEYFIT
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 34 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
The provided text describes the 510(k) summary for the TheyFit Male Condom, detailing its performance data and substantial equivalence to a predicate device. Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (leveraged predicate data) | Device identical to predicate in material composition and manufacturing; predicate device's biocompatibility testing leveraged. |
| Airburst | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Water Leak | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Dimensional Analysis | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Clinical Performance (Total Clinical Failure Rate) |
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(429 days)
THEYFIT
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 22 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
This is a summary of the acceptance criteria and study information for the TheyFit Male Condom, based on the provided 510(k) summary (K122219).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Material composition and manufacturing process identical to predicate device. | TheyFit Condoms are identical with regard to material composition and manufacturing process as the predicate device. Biocompatibility testing completed on the predicate device was leveraged. |
| Airburst | ASTM D3492-08 and ISO 4074:2002 | Acceptance criteria met |
| Water Leak | ASTM D3492-08 and ISO 4074:2002 | Acceptance criteria met |
| Freedom from Holes | ASTM D3492-08 and ISO 4074:2002 | Acceptance criteria met |
| Dimensional Analysis | ASTM D3492-08 and ISO 4074:2002 | Acceptance criteria met |
| Clinical Performance (Breakage, Slippage, Acceptability) | Not explicitly stated in terms of numerical criteria within the summary, but implied to be sufficient for demonstrating safety and effectiveness compared to predicate. | Clinical performance data was provided for sizes O77-Z22 via a published clinical study (Reece M, Herbenick D, Sanders SA et al, Breakage, slippage and acceptability outcomes of a condom fitted to penile dimensions. Sex Transm Infect 2008; 84(2):143-149.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary leverages a published clinical study for clinical performance data.
- Sample Size: Not specified in the 510(k) summary. The summary refers to the publication "Reece M, Herbenick D, Sanders SA et al, Breakage, slippage and acceptability outcomes of a condom fitted to penile dimensions. Sex Transm Infect 2008; 84(2):143-149." To find the exact sample size, the full published study would need to be consulted.
- Data Provenance: The 510(k) summary does not explicitly state the country of origin. The study is cited in "Sex Transm Infect 2008; 84(2):143-149," which is a journal published by the British Medical Journal (BMJ) group, but this doesn't confirm the study's geographic location. It is also not specified whether the study was retrospective or prospective, though clinical performance studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The clinical study for condoms involves user performance and outcomes (breakage, slippage, and acceptability), not interpretation by experts.
4. Adjudication Method for the Test Set
This information is not applicable, as ground truth was not established via expert consensus requiring adjudication. Clinical outcomes were directly observed and reported by users in the clinical study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where multiple readers interpret cases. The clinical study cited here focuses on user-reported outcomes of condom performance. There is no mention of comparing human readers' performance with and without AI assistance, as this is not an AI-enabled device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a medical device (condom), not a software algorithm or AI. The clinical performance study assessed the device's function in real-world use.
7. The Type of Ground Truth Used
For the clinical performance, the "ground truth" was based on user-reported outcomes regarding breakage, slippage, and acceptability during actual use. This aligns with standard clinical evaluation for such devices.
For the other performance data (Airburst, Water Leak, Freedom from Holes, Dimensional Analysis), the "ground truth" was established by meeting specified engineering and safety standards (ASTM D3492-08 and ISO 4074:2002).
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical device (condom) and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this device.
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