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510(k) Data Aggregation
(102 days)
The Disposable Circular Stapler has application throughout the alimentary tract for end-to-side and side-to-side anastomoses.
The Disposable Circular Staplers, can anastomose organs by firing into the tissues of alimentary canal two staggered (interior and exterior) rings of titanium staples and cutting off inside tissue with the circular blades simultaneously. The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. The instrument is activated by squeezing the handles firmly as far as they will go. Immediately after staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.
The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler), which focuses on establishing substantial equivalence to a predicate device based on technical characteristics and performance testing. This document does not describe a study involving an AI/human reader in the loop, or the use of expert consensus/pathology for establishing ground truth as would be relevant for an AI/ML device. Therefore, much of the requested information cannot be extracted from this document.
However, based on the provided text, here's what can be extracted regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance
The document mentions several performance tests were conducted. While specific acceptance criteria values are not explicitly stated, the implication is that the device met the criteria for each test to claim substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual appearance (Acceptable) | Passed (implied, as stated no change in basic design) |
| Dimensions (Within specifications) | Passed (implied) |
| Sharpness (Adequate) | Passed (implied) |
| Operational Performance (Functional) | Passed (implied) |
| Cutting Performance (Effective) | Passed (implied) |
| Staple formation and closed staple height (Correct) | Passed (implied) |
| Pressure resistance (Adequate) | Passed (implied) |
| Corrosion resistance (Acceptable) | Passed (implied) |
| Packaging performance (Adequate) | Passed (implied) |
| Hardness (Within specifications) | Passed (implied) |
| Firing Force (Within specifications) | Passed (implied) |
| Energy Testing (Within specifications) | "Testing of the staples during insertion and extraction showed that there are no appreciable differences in the energy needed to insert or extract the staples." |
| Sterility (Sterile) | Passed (implied, "sterility verfication was completed per USP standards") |
| Biocompatibility (Biocompatible) | "Biocompatibility testing was performed to ensure the stapler was constructed of material which passes the Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11." |
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified in the document. The document only states that "the same testing submitted for the predicate was repeated."
- Data provenance: The testing was conducted by Changzhou Kangdi Medical Stapler Co., Ltd. The document does not specify the country of origin of the data beyond the company's location in China. The testing appears to be for the device itself rather than patient data, and thus is an in vitro/benchtop study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical stapler, and the "ground truth" for its performance is established through engineering and sterility testing, not expert interpretation of medical images or data.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements (e.g., dimensions, hardness, force, pressure resistance) or pass/fail criteria (e.g., visual inspection, sterility). There is no "adjudication" in the sense of resolving differences between expert opinions.
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 document describes a medical stapler, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes a medical stapler, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through:
- Engineering specifications and standards: For dimensions, sharpness, operational/cutting performance, staple formation, hardness, firing force, energy testing.
- Material standards: For implantable staple material (Standard for Unalloyed Titanium for Surgical Implant Applications).
- Biological evaluation standards: For biocompatibility (Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11).
- Packaging and sterility standards: USP standards for sterility and packaging verification.
- Corrosion resistance tests.
8. The sample size for the training set
Not applicable. This document describes a medical stapler, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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