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510(k) Data Aggregation
(273 days)
GLOVE PORT
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.
The GLOVE PORT is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.
The document describes a 510(k) premarket notification for the "Glove Port" device, which is an endoscopy surgery instrument. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the bench testing performed to demonstrate functionality and mechanical safety. The reported device performance is that these tests showed the device is "as safe, as effective and performs in a substantially equivalent manner to the predicate device."
| Acceptance Criteria (Implied from Bench Tests) | Reported Device Performance |
|---|---|
| Comparative leak rate (without instruments) | Substantially equivalent to predicate devices |
| Comparative leak rate (with instruments) | Substantially equivalent to predicate devices |
| Comparative leak rate (after vigorous manipulation of instruments) | Substantially equivalent to predicate devices |
| Insufflation flow rate | Substantially equivalent to predicate devices |
| Insertion-withdrawal forces of instruments | Substantially equivalent to predicate devices |
| Determination of minimum size of skin incision | Substantially equivalent to predicate devices |
| Evaluation of device fixation | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Bench testing is performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the bench tests. The tests appear to be physical or mechanical assessments rather than clinical evaluations requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for the bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The "Glove Port" is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be the established functional and safety specifications for such devices, determined by engineering, regulatory, and mechanical principles. The comparison is made against the performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. The "Glove Port" is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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