(325 days)
Artelon® CMC Spacer Arthro intended to be implanted into first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.
ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea. ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device. ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.
The provided text is a 510(k) summary for the ARTELON CMC Spacer Arthro. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence to a previously cleared device.
Therefore, many of the requested details about acceptance criteria and study design for measuring device performance cannot be extracted from this document because such a study was not performed or reported in this summary.
Here's a breakdown of the information that can be extracted or inferred based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of specific performance metrics for clinical outcome (e.g., success rate, pain reduction, range of motion improvement). | "The new product met the same release specifications as the previously cleared device." |
| "Performance bench testing was utilized needed to demonstrate Substantial Equivalence." | |
| Demonstrated substantial equivalence to a predicate device (ARTELON CMC Spacer, K040070) based on dimensions, materials, basic design, and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical "test set" in the context of a performance study (e.g., measuring disease detection accuracy) was conducted for this 510(k) submission. Performance was assessed via bench testing and comparison to a predicate device.
- Data Provenance: Not applicable for a clinical performance study. The submission describes bench testing which would typically be conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No ground truth establishment by experts for a clinical performance study was reported.
4. Adjudication Method for the Test Set
- Not applicable. No clinical performance study requiring adjudication was reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance evaluation or comparison with AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- No, a standalone (algorithm only) performance study of this nature was not done. The device is a physical implant, not an algorithm. Performance was assessed through engineering bench tests and comparison to a predicate device.
7. Type of Ground Truth Used
- For demonstrating equivalence: The "ground truth" was the performance and characteristics of the predicate device (ARTELON CMC Spacer, K040070), along with compliance to recognized standards (ISO 10993, ISO 14971, etc.) through bench testing.
- For clinical outcomes: Not applicable, as detailed clinical outcomes data from a specific study for this device's 510(k) submission are not provided.
8. Sample Size for the Training Set
- Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is a physical implant, not an AI/ML algorithm.
Summary of the 510(k) Approach:
The 510(k) submission for the ARTELON CMC Spacer Arthro focused on demonstrating substantial equivalence to a previously cleared device (ARTELON CMC Spacer, K040070). This involved:
- Bench Testing: Ensuring the new device met the same "release specifications" as the predicate device and complied with relevant ISO and AAMI standards for biocompatibility, sterilization, packaging, and risk management.
- Comparison of Features: Highlighting the similarity in dimensions, materials, basic design, and intended use between the new device and the predicate.
This type of submission typically does not include de novo clinical studies with specific performance metrics like sensitivity or specificity, or studies involving human readers or AI algorithms for diagnostic purposes. The "acceptance criteria" here are primarily around meeting engineering specifications and demonstrating equivalency to a device already deemed safe and effective by the FDA.
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.