(125 days)
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is a triegersqueeze mechanical device with a curved cannula, pre-loaded with 20 absorbable straps. The ETHICON SECURESTRAP™ Fixation Device straps are made of a blend of polydioxanone dyed with D&C Violet No. 2 and a L(-)-Lactide/glycolide copolymer. The inserted length of the strap is 6.7 mm.
The provided text describes a 510(k) summary for the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device. It outlines the device's characteristics, intended use, and a performance testing program to demonstrate its safety and effectiveness compared to a predicate device.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table format. Instead, it describes a testing program designed to show that the new device "meets the device requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 standards | Biocompatibility testing was conducted in accordance with the tests recommended in the ISO 10993-1 standard. (Implied: Device met these standards). |
| Physical/Performance Measurements: Function as intended | Bench top physical/performance measurements including mesh fixation force and mesh compatibility testing in an animal tissue model were conducted. (Implied: Device performed as intended, demonstrating satisfactory mesh fixation force and compatibility, and meeting user specifications). The device uses the same fundamental scientific technology and principles of operation. |
| Substantial Equivalence: To predicate device | Performance data (from biocompatibility and physical/performance measurements) "demonstrates that the device is as safe and as effective as the predicate device for the intended use." Minor delivery system differences raised no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the "bench top physical/performance measurements" or the "animal tissue model." It mentions "Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard," which typically involves specific sample sizes per test, but these are not detailed here.
- Sample Size (Test Set): Not explicitly stated.
- Data Provenance: Not explicitly stated. The testing includes "bench top" (laboratory) and "animal tissue model" experiments, indicating controlled experimental settings rather than human clinical data. It is prospective in nature as these tests were performed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable (N/A) to this study. The tests described are laboratory-based (benchtop and animal model) and assess physical and material properties, as well as functional performance (e.g., mesh fixation force). They do not involve expert interpretation for 'ground truth' in the way a diagnostic AI study would (e.g., radiologists reviewing images). The "ground truth" here is objective measurement against defined specifications or comparison to the predicate device's performance.
4. Adjudication Method for the Test Set
This is not applicable (N/A). Adjudication methods are typically employed in studies where human reviewers or interpreters make judgments (e.g., clinical trials, AI diagnostic studies) and discrepancies need to be resolved. The studies mentioned (biocompatibility, benchtop, animal tissue model) are objective measurements and comparisons, not subjective interpretations requiring adjudication.
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
This is not applicable (N/A). The device is a physical fixation device for surgical procedures (hernia repairs). It is not an AI diagnostic or assistive tool, so an MRMC study comparing human reader performance with or without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable (N/A). As stated in point 5, the device is a physical surgical tool and does not involve AI or an algorithm that would operate in a standalone manner.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance data in this context refers to:
- Pre-defined material and functional specifications: For biocompatibility (ISO 10993-1 standards) and physical performance (e.g., mesh fixation force).
- Performance of the predicate device: The new device's performance is compared against the known, established performance of the ETHICON SECURESTRAP™ 5 mm Absorbable Strap Fixation Device (K093845) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable (N/A). This product is a medical device, not an AI or machine learning model that requires a "training set." The product's design and manufacturing processes are likely informed by prior engineering principles, material science, and iterative design, but not a data-driven "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (N/A), as there is no "training set" for this type of device.
§ 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.