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510(k) Data Aggregation
(163 days)
Intended Use:
The Simparo Anchor Line Fixation System, when used for fixation of bone or soft-tissue-to-bone, is intended as an anchor fixation system, a distributing suture tension over areas of ligament or tendon repair.
Indications for Use:
Specifically, the Simparo Anchor Line Fixation System is indicated for carpometacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis.
The Simparo Anchor Line Fixation System is a dual anchor construct used to provide stabilization of the thumb and index metacarpals for treatment of carpometacarpal (CMC) arthritis. The Anchor Line Fixation System consists of an index anchor (5mm) and a thumb anchor (5mm) connected by a single strand of #2 Teleflex Force Fiber nonabsorbable braided suture. This construct provides a suspension sling as a supportive device to maintain the thumb and index metacarpals in proper alignment during capsular healing, hematoma and scar tissue formation following a trapeziectomy (removal of the trapezium) for the treatment of thumb CMC osteoarthritis. The Anchor Line Fixation System is manufactured from titanium alloys, stainless steel and PEEK.
The Simparo Anchor Line Fixation System is a medical device intended for carpometacarpal (CMC) joint arthroplasty. The provided text outlines the device's technical specifications, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study designs (including sample sizes for test or training sets, ground truth establishment, or expert qualifications), or MRMC comparative effectiveness study results as requested by the prompt. The information is primarily focused on regulatory submission for 510(k) clearance.
Therefore, many of the requested fields cannot be populated based on the provided text.
Here's an attempt to extract relevant information and note what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Test: | |
| LAL endotoxin level ≤ 20 EU/device | "All samples passed the endotoxin testing." (Specific results not given, but imply ≤ 20 EU/device) |
| Mechanical Testing: | |
| Details not provided | "Mechanical testing and engineering analyses were conducted to demonstrate the Simparo Anchor Line Fixation System and to demonstrate substantial equivalence to the predicate components." (Specific criteria, metrics, and outcomes are not detailed.) |
| Substantial Equivalence: | |
| No new questions of safety and effectiveness | "Any differences do not raise new questions of safety and effectiveness" |
| At least as safe and effective as predicate devices | "The proposed subject device is at least as safe and effective as the legally marketed predicate device." |
2. Sample sized 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 in the provided text for mechanical or endotoxin testing. The endotoxin test mentions "all samples," but the number is not quantified.
- Data Provenance: Not specified.
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)
- Not applicable as this is not a diagnostic AI device requiring expert ground truth for image or data interpretation. The evaluation is based on mechanical and biological performance against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. The testing described (bacterial endotoxin, mechanical) does not involve adjudication by multiple individuals in this manner.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical fixation system, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance testing for the Simparo Anchor Line Fixation System focuses on its mechanical and biological characteristics as a standalone device (e.g., strength, biocompatibility, endotoxin levels). There is no "algorithm" or human-in-the-loop component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the Bacterial Endotoxin Test, the ground truth is established by the accepted limit of endotoxins according to standards (≤ 20 EU / device).
- For Mechanical Testing, the "ground truth" would be engineering specifications and performance benchmarks derived from the predicate devices and relevant industry standards.
- For Substantial Equivalence, the "ground truth" is regulatory comparison against legally marketed predicate devices and assessment against general safety and effectiveness principles.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/machine learning system that requires a training set.
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