(190 days)
The Mitek PDS/PGA Staple is an absorbable implant used in the fixation of scaffolding (for example periosteal autograft, collagen membranes or synthetic scaffolding) to articular cartilage lesions of the knee.
The Mitek PDS/PGA Staple is a sterile, implantable device intended for single patient use only. The PDS/PGA Staple consists of an injection molded polydioxanone (PDS) U-shaped strap and two injection molded polyglycolic acid (PGA) cones. The PDS U-shaped strap is insert-molded around the two injection molded PGA cones, resulting in a single, mechanically joined, PDS/PGA Staple construct. The PDS/PGA Staple is manufactured from two absorbable polymers that are well-known and well-characterized and have been used in a multitude of commercially available medical devices.
The provided text is a 510(k) summary for the Mitek PDS/PGA Staple. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria or detail a specific study with performance metrics in the way one might expect for an AI/ML device.
This document focuses on demonstrating substantial equivalence to existing, legally marketed devices. The "safety and performance" section refers to studies, but these are to show equivalence, not to meet specific, quantifiable performance targets set as acceptance criteria for a novel device.
Therefore, many of the requested categories cannot be directly answered from the provided text because it's a submission for a medical device that established substantial equivalence through in vitro and in vivo animal studies, and biocompatibility data, rather than a comparative effectiveness study with human readers or AI algorithms.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: Demonstration of substantial equivalence to predicate devices (6-0 Coated VICRYL Absorbable Suture, PDS II Suture, Mitek "H" Fix Meniscal Fastener) based on safety and performance. | Performance Studies (as evidence for equivalence): |
- Biocompatibility data
- In vitro strength retention assessment
- Simulated use evaluation
- In vivo animal studies |
| Safety Profile | Data provided supports safety and performance. |
| Performance Profile | Data provided supports safety and performance to be substantially equivalent to currently marketed devices. |
| Materials | Manufactured from two absorbable polymers (PDS and PGA) that are well-known and well-characterized. |
| Operating Principle | Similar to predicate devices. |
| Intended Use | Fixation of scaffolding to articular cartilage lesions of the knee, similar to predicate devices. |
| Manufacturing Processes | Similar to predicate devices. |
| Sterilization Processes | Similar to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "in vitro strength retention assessment," "simulated use evaluation," and "in vivo animal studies," but does not provide specific sample sizes for these.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation. The performance is assessed through laboratory and animal studies, not human expert evaluations for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a medical device of this type. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple reviewers.
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
- No. This is not an AI/ML device, and an MRMC study is not relevant to its type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be derived from the specific metrics measured in the biocompatibility data, in vitro strength retention assessment, simulated use evaluation, and in vivo animal studies. For example, in vitro strength retention might be measured against a predefined mechanical standard, and in vivo animal studies would assess biological response and tissue integration. These are objective measurements rather than expert consensus on interpretative data.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.