(59 days)
The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.
This document is a 510(k) Premarket Notification from the FDA regarding the "PANTHER Cutter Stapler". It is a regulatory document and does not contain information about a study that proves the device meets specific acceptance criteria in the manner of an AI/algorithm-based medical device.
Instead, this document describes the device, its intended use, and states that no clinical or animal studies were included in the submission. The manufacturer relies on bench testing to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information in the format of an AI/algorithm study. However, I can provide the available information regarding the bench tests mentioned:
Acceptance Criteria and Device Performance (Bench Tests)
The document mentions that bench tests were conducted to confirm substantial equivalence to a predicate device, not to meet specific quantitative performance metrics against clinical ground truth. The acceptance criteria for these bench tests would typically be defined by engineering specifications and comparative performance to the predicate device. The document does not provide the specific numerical acceptance criteria or the reported performance values for each test.
| Acceptance Criteria Category (Implied by Test Name) | Reported Device Performance (No specific values provided in document) |
|---|---|
| Physical Specification | "perform as intended and are substantially equivalent" |
| Closed Staple Height Dimensions | "perform as intended and are substantially equivalent" |
| Pressure Resistance | "perform as intended and are substantially equivalent" |
| Maximum Tensile Strength | "perform as intended and are substantially equivalent" |
| Force Required to Fire Stapler | "perform as intended and are substantially equivalent" |
Since this is a submission for a surgical stapler and not an AI/algorithm device, the following points are not applicable or the information is not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/algorithm study. For the bench tests, the sample sizes are not provided in this regulatory summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench test results are typically measured against engineering specifications or compared directly to a predicate device's performance, not expert consensus as ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical study is included in this submission."
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not an AI/algorithm device.
- The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and the performance of the predicate device.
- The sample size for the training set: Not applicable, as no AI model is being trained.
- 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.