(58 days)
The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-to-bone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during ligament or tendon repair and reconstruction procedures such as Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Patellofemoral Ligament (MPFL), and Posterolateral Corner (PLC).
Stryker Endoscopy is introducing a new device configuration as a line extension to the ProCinch product family, the Stryker ProCinch No Button Adjustable Loop Implant (ProCinch NB), for use in orthopedic applications.
All ProCinch Adjustable Loop device configurations are cortical suspension fixation implants that consist of an adjustable nonabsorbable UHMWPE/polyester suture loop. The ProCinch RT and ProCinch ST configurations have three non-implanted polyester sutures that are intended to facilitate insertion of the implant and flipping of the button. The ProCinch RT and ProCinch ST configurations are provided preassembled to a titanium button. The ProCinch NB configuration contains one non-implanted polyester suture that is intended to facilitate insertion of the implant. The ProCinch NB configuration is provided without a titanium button; it is intended to be used with a separate compatible button to achieve fixation. The user will assemble a compatible button to the ProCinch NB suture loop after passing the suture loop implant through the bone tunnel. All configurations are provided sterile and are labeled for single use.
The provided text describes a 510(k) premarket notification for a medical device called the Stryker ProCinch Adjustable Loop Device. The submission aims to introduce a new configuration (ProCinch No Button) and expand the indications for use.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cyclic Extension | Met all acceptance criteria established by the predicate device. |
| Ultimate Tensile Strength (UTS) | Met all acceptance criteria established by the predicate device. |
| Material-mediated Pyrogenicity | Passing results below the required limits. |
| Bacterial Endotoxins | Passing results below the required limits. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies mentioned are non-clinical benchtop tests, not human-based evaluations requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable given the nature of the non-clinical benchtop testing. There was no "test set" in the context of human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies were non-clinical benchtop tests.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device described is a physical medical implant (an adjustable suture loop) and not a software algorithm.
7. The Type of Ground Truth Used
For the non-clinical benchtop testing, the "ground truth" was established by the acceptance criteria set by the predicate device and relevant industry standards for mechanical and biocompatibility testing. This is not "expert consensus," "pathology," or "outcomes data" in the traditional sense for diagnostic or prognostic devices.
8. The Sample Size for the Training Set
This information is not provided and is generally not relevant for this type of medical device submission. The device is a physical implant, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for this physical medical device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.