(177 days)
Indicated for:
- Nasal soft-tissue and cartilage reconstruction
The Ethicon Inc. PDS Flexible Plates are indicated for:
– Nasal soft-tissue and cartilage reconstruction
PDS Flexible Plate are made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerisation of the monomer p-dioxanone. PDS Flexible Plate are dyed with D+C violet # 2 (Color index Number 60725). PDS Flexible Plate are available in various film thicknesses, some of which are also perforated. PDS Flexible Plate can be trimmed to suit the anatomical conditions. The PDS Flexible Plate is a sterile, single use device.
This 510(k) premarket notification describes a medical device, the PDS Flexible Plate, which is a synthetic absorbable polymer indicated for nasal soft-tissue and cartilage reconstruction. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found for novel AI/ML-driven diagnostics.
Therefore, many of the requested sections regarding AI/ML study design, reader studies, and detailed performance metrics are not applicable to this 510(k) submission. This document primarily reports on bench-top and preclinical evaluations to support substantial equivalence.
Here's the information that can be extracted and a clear statement of what is not applicable:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for this 510(k) submission are not explicitly stated in terms of quantitative performance metrics for a diagnostic or AI device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means the device must show comparable characteristics in relevant areas and raise no new issues of safety or effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Similar Intended Use | "The PDS Flexible Plate has the same intended use... as its predicate devices." (Page 2) |
| Similar Indications for Use | "...and similar indications for use... as its predicate devices." (Page 2) |
| Similar Technological Characteristics | "PDS Flexible Plate underwent an extensive performance testing program to support that the PDS Flexible Plate fulfill the device requirements as defined in user specifications, function as intended, and are substantially equivalent to the predicate devices." (Page 2) |
| Similar Principles of Operation | "...and principles of operation as its predicate devices." (Page 2) |
| No New Issues of Safety or Effectiveness | "The technological differences between the PDS Flexible Plate and the predicate devices raise no new issues of safety or effectiveness." (Page 2) |
| Comparable Physical Properties (Thickness, Tensile, Flexibility) | "Bench top testing compared the device to predicate devices in thickness, tensile properties and flexibility and was shown to have comparable characteristics." (Page 2) |
| Achieve Intended Use (Preclinical Evaluation) | "Preclinical evaluations with the device and its predicates demonstrate the device's ability to achieve the intended use and support substantial equivalence." (Page 2) |
The following sections are NOT APPLICABLE as this is a 510(k) submission for a non-AI/ML implantable medical device, not a diagnostic or AI-powered system.
- Sample size used for the test set and the data provenance: Not applicable. Performance testing was "bench top" and "preclinical evaluations" and not based on a test set of patient data as for an AI/ML diagnostic.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML diagnostic test set is not relevant for this device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML diagnostic. For this device, "ground truth" relates to the physical and biological performance in preclinical models or bench tests demonstrating its ability to function as intended and comparably to predicates.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model for this device.
- How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information:
- Device Name: PDS Flexible Plate
- Intended Use: Nasal soft-tissue and cartilage reconstruction.
- Study Type: Bench top testing and preclinical evaluations to support substantial equivalence.
- Primary Objective of Study: To demonstrate that the PDS Flexible Plate fulfills device requirements, functions as intended, and is substantially equivalent to predicate devices (Orthosorb Pin, PDS Suture, MACROPORE ENT Reconstruction Film, LactoSorb Sheets, Silmax Sheeting).
- Key Findings: The device demonstrated comparable characteristics to predicate devices in thickness, tensile properties, and flexibility. Preclinical evaluations showed the device's ability to achieve intended use.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.