(252 days)
Intended for use in the approximation of soft tissue and prosthetic materials.
The ThruPort Knotting Instrument is used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot and is indicated for use in the approximation of soft tissue and prosthetic materials.
Edwards Lifesciences' ThruPort OptiClip Knotting System is a sterile, nonpyrogenic, single-use surgical instrument made of metal and polymeric materials. lt consists of the ThruPort OptiClip Knotting Instrument and the ThruPort OptiClip Knot Loader.
This document describes the regulatory approval for the Edwards ThruPort OptiClip Knotting System. It is a not a clinical study report and therefore does not contain information about acceptance criteria or device performance as would be expected for a clinical study.
However, it does describe the functional and safety testing performed, and that all results met acceptance criteria. It also details the MR safety information testing.
Here's an analysis of the provided text based on your request, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
This information is not provided in a table format, nor are specific quantitative acceptance criteria or reported performance values given. The document states: "The functional data indicate that the device performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were completed and all results met acceptance criteria." This implies that acceptance criteria were defined and met, but the specific details are not disclosed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes "Functional bench testing (design verification)" and "Non-clinical testing" for MR Conditional assessment. It does not mention a "test set" in the context of human subjects or clinical data. All testing appears to be laboratory-based verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The testing performed is functional and safety testing, not diagnostic performance evaluation requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically associated with clinical studies involving human observers or image interpretation, which is not the nature of the testing described.
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 information is not applicable/provided. This device is a surgical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a medical instrument and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the functional and safety testing, the "ground truth" would be the engineering specifications, established medical device standards (e.g., ISO 10993-1:2009 for biocompatibility), and internal design requirements. For MR safety, the ground truth is based on established physics principles and testing methodologies for MR compatibility. There is no biological or diagnostic "ground truth" in the clinical sense mentioned in the document.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
Summary of available information related to acceptance criteria and study (non-clinical):
The document describes several non-clinical tests (functional bench testing, MR evaluation testing, biocompatibility, sterility, shelf life, packaging, design validation) performed to demonstrate that the device is substantially equivalent to a predicate device and meets safety and effectiveness requirements.
- Acceptance Criteria Overview: The document broadly states that "all results met acceptance criteria" for the functional tests. For MR safety, specific conditions for MR Conditional use are provided (static magnetic field, spatial gradient, SAR, temperature rise, and image artifact size), which serve as the acceptance criteria for claiming MR Conditional status.
- Study Type: Non-clinical (laboratory/bench) testing for design verification and validation.
- MR Evaluation Testing:
- Acceptance Criteria (as stated in the document):
- Static magnetic field must be 1.5 Tesla and 3.0 Tesla only.
- Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m) or less.
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode).
- Maximum temperature rise of less than 1.5 ℃ after 15 minutes of continuous scanning.
- Image artifact caused by the nitinol knot extends approximately 1 mm from the knot with a spin echo pulse sequence in a 3.0 T MRI system, and 5 mm with a gradient echo pulse sequence in a 3.0 T MRI system.
- Reported Device Performance (as stated in the document): The device (specifically the nitinol knot) meets these conditions and is therefore classified as "MR Conditional." The image artifact characteristics are also reported.
- Sample Size for Test Set: Not explicitly stated, but typical for non-clinical MR testing, it would involve a specific number of device samples.
- Data Provenance: Non-clinical (laboratory testing).
- Ground Truth: Engineering specifications and established MR safety testing standards.
- Acceptance Criteria (as stated in the document):
In conclusion, this document primarily serves as a regulatory clearance letter and a 510(k) summary, detailing the types of tests performed to achieve substantial equivalence. It does not provide the granular details of acceptance criteria and performance data typically found in a clinical study report for diagnostic devices.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.