(147 days)
For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.
For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.
Reusable surgical stapler with a single use reload
The provided text describes a 510(k) summary for the ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study with specific performance metrics against those criteria for the ReliaMax device itself.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
There is no explicit table of acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity) against which the ReliaMax™ device's performance is reported. Instead, the document states: "The results of this testing demonstrates that the ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device."
The performance evaluations conducted are listed as:
| Performance Evaluation | Reported Device Performance |
|---|---|
| Firing and Retraction Force | Results demonstrate substantial equivalence to the predicate device. |
| Clamping and Unclamping Force | Results demonstrate substantial equivalence to the predicate device. |
| Staple Formation Verification | Results demonstrate substantial equivalence to the predicate device. |
| Hemostasis | Results demonstrate substantial equivalence to the predicate device. |
| Burst Strength | Results demonstrate substantial equivalence to the predicate device. |
| Lung Air Leak | Results demonstrate substantial equivalence to the predicate device. |
| Lifecycle Reliability Test | Results demonstrate substantial equivalence to the predicate device. |
Note: The document does not provide the specific numerical results of these tests for either the ReliaMax™ device or the predicate device, nor does it define explicit "acceptance criteria" they were compared against, beyond the general goal of demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in vitro and in vivo performance evaluations" were conducted. However, no specific sample sizes for these test sets are provided, nor is the data provenance (e.g., country of origin, retrospective/prospective nature) detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the provided text describes a medical device study (stapler for surgical procedures) which typically relies on objective physical or biological measurements rather than expert consensus on image interpretation or similar diagnostic tasks. Ground truth for a surgical stapler would involve measuring physical properties and biological outcomes in tested tissues/animals.
4. Adjudication Method
This information is not applicable for the type of device study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable as this is a surgical stapling device, not an imaging or diagnostic device requiring human reader interpretation. No human-in-the-loop performance is described.
6. Standalone Performance Study
Yes, a standalone performance study was done for the ReliaMax™ device. The "Performance Data" section explicitly states: "In vitro and in vivo performance evaluations were conducted to demonstrate that ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are safe and effective and that they perform as intended." This indicates algorithmic (device-only) performance testing. However, the exact methodology and detailed results for these evaluations are not provided beyond the general summary.
7. Type of Ground Truth Used
The ground truth for the "in vitro and in vivo performance evaluations" would have likely been based on objective measurements of physical and biological properties. For example:
- Staple Formation Verification: Visual inspection or microscopic analysis of staple formation.
- Hemostasis: Measurement of blood leakage.
- Burst Strength: Measurement of pressure at which the stapled anastomosis fails.
- Lung Air Leak: Measurement of air leakage from stapled lung tissue.
- Forces and Reliability: Physical measurements using load cells and endurance testing.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of this device study. Surgical staplers are typically evaluated through engineering tests and non-clinical (e.g., animal, cadaver) studies, not through AI/machine learning models that require training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as no training set for an AI/ML model is mentioned.
§ 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.