Search Results
Found 1 results
510(k) Data Aggregation
(142 days)
The Ignite Orthopedics Revolution Radial Head is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
This is a 510(k) premarket notification for the Revolution Radial Head, a medical device for radial head replacement. The provided document is a clearance letter from the FDA, a 510(k) summary, and indications for use. It details the device's characteristics and its substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | Bending stress analysis demonstrated that the strength of the worst-case Revolution Radial Head is greater than the strength of the worst-case predicate device and is adequate for its intended use. |
| Endotoxin Level | Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of <20 EU/device. |
| Packaging Integrity | Packaging integrity testing met requirements per ASTM D4169 Distribution Cycle 13, Assurance Level 1. |
| Package Shelf Life | One-year accelerated aging was conducted according to ASTM F1980-16 to determine Package Shelf Life. (The document states it was conducted to determine shelf life, implying it met the criteria, though the specific result value for shelf life isn't explicitly given here, but rather the method used to establish it.) |
| Sterility Assurance Level | Sterilization validations were completed using the VDmax method specified in ISO 11137-1:2006/A1:2013, achieving a Sterility Assurance Level (SAL) of 10-6. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for each test set beyond mentioning "worst-case samples" for endotoxin testing. The testing described is non-clinical (mechanical, sterilization, packaging) and does not involve human data. Therefore, there's no information on data provenance related to human subjects or retrospective/prospective studies.
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. The tests performed are non-clinical and do not involve expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical device submission based on bench testing, not a clinical study requiring adjudication of results.
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
Not applicable. No clinical or comparative effectiveness study involving human readers or AI assistance was conducted for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests (mechanical strength, endotoxin, packaging, sterility) is based on established engineering principles, international standards (e.g., ASTM F1537, ASTM D4169, ASTM F1980-16, ISO 11137-1:2006/A1:2013), and validated laboratory methods. There is no expert consensus, pathology, or outcomes data used for these types of tests in this submission.
8. The sample size for the training set
Not applicable. This device is a mechanical implant and does not involve a training set as would be used in machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Ask a specific question about this device
Page 1 of 1