(100 days)
Disposable Linear Stapler: The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues. Disposable Linear Cutter: The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Disposable Linear Stapler: The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in a variety of sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness. The model number defines the staple line. For example, the 30 mm instruments create a 30-mm staple line, the 45 mm instruments create a 45-mm staple line, the 60 mm instruments create a 60-mm staple line and the 90 mm instruments create a 90-mm staple line. Disposable Linear Cutter: The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
This document describes the 510(k) premarket notification for the "Disposable Linear Stapler" and "Disposable Linear Cutter" manufactured by Changzhou Kangdi Medical Stapler Co. Ltd. This submission is a modification to a previously cleared device. Therefore, the study presented focuses on demonstrating that the modifications do not alter the established safety and effectiveness of the device compared to its predicate.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implies that the acceptance criteria are met if the modified device demonstrates equivalent performance to the predicate device, particularly regarding the force required for staple delivery and removal, as well as biocompatibility and sterility attributes. Specific quantitative acceptance criteria are not explicitly stated in the provided text. Instead, the testing aimed to show "consistency" and "no appreciable differences" or successful passing of standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Energy to deliver staples consistent with predicate device | "Bench testing was performed to demonstrate the energy to deliver staples... was consistent with the predicate device." |
| Energy to remove staples consistent with predicate device | "Bench testing was performed to demonstrate... to remove staples was consistent with the predicate device." |
| No appreciable differences in energy for staple insertion/extraction due to modifications | "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." |
| Biocompatibility in accordance with ISO 10993 standards | "Biocompatibility testing was performed to ensure the stapler and cutters were constructed of material which passes the ISO 10993 benchmarks. The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11." |
| No effect on sterility process, materials, or packaging | "The modifications to the devices have not affected the sterility process, materials or packaging. For verifications, packaging and sterility verfications were completed." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench testing" and "Biocompatibility testing" but does not specify the sample sizes used for these tests. The data provenance is not explicitly stated in terms of country of origin, but the submitting company is "Changzhou Kangdi Medical Stapler Co., Ltd" based in China, suggesting the testing likely occurred there. The studies are prospective in the sense that they were conducted specifically for this submission to demonstrate substantial equivalence of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The studies are bench tests and biocompatibility tests, which typically do not involve human expert adjudication of performance in the way a clinical study or image analysis study would.
4. Adjudication Method for the Test Set:
This information is not applicable to the type of bench and biocompatibility testing described. No human expert adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The studies described are bench tests and biocompatibility tests, not clinical studies involving human readers or patient cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a medical stapler/cutter, not an AI algorithm. The performance evaluation is based on mechanical and material properties, not an algorithm's output.
7. The Type of Ground Truth Used:
The ground truth for the bench testing appears to be based on objective measurements of physical properties, such as the force required for staple delivery and removal. For biocompatibility, the ground truth is established by compliance with the internationally recognized ISO 10993 standards. These are objective, measurable criteria rather than expert consensus on a subjective outcome.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of this device's evaluation, as it is a mechanical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable for the reasons stated above.
§ 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.