(74 days)
The Hemaway Seat is for the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only.
The Hemaway Seat is an injection molded polypropylene copolymer plastic seat attached to a toilet seat that discretely locks into the contoured lid when not in use. The product is adjustable and is available in round and elongated versions. The product is assembled and attaches to the toilet in the same manner as a regular toilet seat.
This document is a 510(k) summary for the Hemaway Seat. It focuses on establishing substantial equivalence to predicate devices, rather than presenting a study demonstrating new acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.
Here's a breakdown of what can be extracted and what is not provided based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as per a new clinical performance study. The device is being cleared based on substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it shares similar characteristics and intended use with the predicates.
- Reported Device Performance: No quantitative performance data is provided from a study in this submission. The performance is implied to be similar to the predicate devices for temporary relief of hemorrhoid pain and pressure.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Hemaway Seat) |
|---|---|---|
| Used in a sitting position | Yes (similar to predicates) | Yes |
| Provides temporary relief from the pressure and pain of hemorrhoids | Yes (similar to predicates Hemorest) | Yes |
| Noninvasive | Yes (similar to predicates) | Yes |
| Contains a “crown” as a component of the device | Not necessarily (different from Hemorest, similar to Derby) | No |
| Can be used in conjunction with other treatments | Yes (similar to predicates) | Yes |
| Made of polypropylene plastic | Yes (similar to Derby, different from Hemorest) | Yes |
| Integrated into toilet seat | Yes (similar to Derby, different from Hemorest) | Yes |
| Portable | No (different from Hemorest, similar to Derby) | No |
| Has direct contact with the body while sitting | Yes (similar to Derby, different from Hemorest) | Yes |
| Available in 2 sizes | Yes (different from Hemorest, similar to Derby) | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not describe a performance study with a test set. It's a 510(k) premarket notification based on substantial equivalence.
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. No ground truth establishment is described for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process 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
- Not Applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No ground truth for a performance study is mentioned. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm or a clinical trial for a new device is described.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment for it is mentioned.
Summary of what is provided:
This submission is a 510(k) for the Hemaway Seat, a device intended for the temporary relief from the pain and pressure of hemorrhoids. The manufacturer (Hemaway LLC) is seeking clearance by demonstrating substantial equivalence to two predicate devices:
The document provides a comparison chart highlighting similarities and differences in features such as intended use, physical characteristics (material, portability, integration into toilet seat), and method of use. The core argument for acceptance is that the Hemaway Seat shares the same intended use (temporary relief of hemorrhoid pain and pressure) and comparable physical characteristics with the predicates, despite some design variations (e.g., plastic vs. foam, integrated vs. portable, presence/absence of a "crown" feature). The FDA concurred with this assessment on December 7, 2007, determining the device was substantially equivalent.
N/A