(47 days)
The EEA™ Hemorrhoid Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The EEA™ Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.
The EEA™ Hemorrhoid stapler is designed for use as a stapling instrument for control of hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST™ staples. The EEA™ Hemorrhoid Stapler is offered in a 33mm diameter and with 3.5mm and 4.8mm staple sizes.
The accompanying accessories are comprised of a purse-string suture Anoscope, a Port, and a Dilator.
The provided text describes a 510(k) summary for the EEA™ Hemorrhoid Stapler and accessories, which focuses on device description, intended use, and substantial equivalence to predicate devices. It does not present acceptance criteria or detailed study results in the way typically found for diagnostic AI/ML devices. Therefore, I cannot construct a table of acceptance criteria vs. reported device performance, nor can I answer many of the specific questions regarding clinical study design, ground truth, or human-in-the-loop performance.
However, based on the information provided, I can infer some general aspects and state what is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | "safe and effective and perform as intended" (general statement) |
| Effectiveness | "safe and effective and perform as intended" (general statement) |
| Intended Use | The device performs surgical treatment of hemorrhoidal disease and creates end-to-end and end-to-side anastomosis in the lower alimentary tract. This aligns with statements. |
| Technological Characteristics | Substantially equivalent to predicate devices regarding stapling technologies. |
| Materials | All components are comprised of materials in accordance with ISO Standard 10993-1. |
| Sterility/Biocompatibility | (Implied by ISO 10993-1 compliance) |
Missing Information: Specific quantitative acceptance criteria (e.g., success rates, complication rates, staple line integrity metrics) are not provided in this document.
2. Sample size used for the test set and the data provenance:
- The document states "In-vitro, in-vivo and ex-vivo performance evaluations were completed".
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 typically relevant for a surgical stapler's performance evaluation and is not provided. The "ground truth" for a stapler would be its mechanical performance and clinical outcome, not expert interpretation of an image or signal.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not provided for this type of device.
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 study is not mentioned as this is a surgical device, not a diagnostic AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document mentions "In-vitro, in-vivo and ex-vivo performance evaluations." For such a device, ground truth would likely involve:
- In-vitro: Mechanical testing (e.g., staple formation, burst pressure of staple lines, force to fire, integrity checks).
- Ex-vivo: Application on animal tissue or cadaveric human tissue to assess staple formation, tissue compression, and seal integrity.
- In-vivo: Animal studies or possibly human clinical data (though not detailed here) to assess short-term safety and effectiveness, healing, and complication rates.
- Specific "ground truth" methods like pathology or expert consensus typically apply to diagnostic or AI devices, which this is not.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.