(218 days)
Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.
The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. The tantalum beads are used as radio opaque markers that are implanted in bone or soft tissue. The tantalum beads are used to measure changes in position of prostheses and anatomical structures with the aid of x-ray images. The tantalum beads are implanted with a manual instrument. The tantalum beads are provided in a cartridge (set of 16 beads, "The tantalum Bead Set") that is inserted into the manual instrument. The instrument inserts one Tantalum bead via manual activation by the surgeon. The Tantalum Bead Set is provided in the sterile condition; sterility is achieved by means of gamma radiation with a sterility assurance of 10 to the power of -6 SAL.
This document describes a 510(k) submission for the "The Tantalum Bead Set," a set of 1mm spherical tantalum markers used as radio-opaque markers. The key change from the predicate device is the sterilization method: the subject device is supplied sterile via gamma irradiation, whereas the predicate was non-sterile and required steam sterilization prior to use.
Since this submission is a Special 510(k) for a change in manufacturing process (sterilization method), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the new sterilization process and updated cartridge material do not negatively impact the device's safety and effectiveness and that the newly sterilized device performs as well as the predicate device. Therefore, the information provided relates to testing done to establish substantial equivalence rather than traditional AI performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance/Conclusion |
|---|---|
| Functional Testing (Debris/Abrasion) | Showed no evidence of debris or abrasion during the functioning of the instrument (which implants the beads). |
| Sterility Validation per ISO 11137-1 and -2:2006 (Gamma Irradiation) | Achieved a Sterility Assurance Level (SAL) of 10⁻⁶. This confirms the new sterilization method is effective. |
| Package Integrity and Shelf-Life Testing (ISTA 2A:2008, ASTM F1980, F2096, F1140) | Established a 5-year shelf-life for the sterilized and packaged Tantalum Bead Set. This ensures the device maintains sterility and integrity over its intended storage period. |
| Substantial Equivalence to Predicate Device | The results indicate that supplying the Tantalum Bead Set as sterile via gamma irradiation is as safe and effective, and will perform as well as the predicate device (which was supplied non-sterile and steam sterilized prior to use). The 1mm tantalum markers are "identical in every respect" between the predicate and subject devices. The cartridge material change from PEEK to PPSU (Radel) for the subject device was noted, but as the cartridge does not contact patient tissues or fluids, this change was considered acceptable given the functional testing results. |
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 specify exact sample sizes for each test. For "Functional testing of the Tantalum Bead Set," it implies that the testing was performed on the device itself. For "Sterility validation" and "Package integrity and shelf-life testing," these are standard medical device validation tests that involve a sufficient number of samples according to the referenced ISO and ASTM standards, but specific numbers are not given here.
- Data Provenance: The manufacturing company, Halifax Biomedical, Inc., is located in Mabou, Nova Scotia, CANADA. Therefore, the testing and data would originate from or be overseen by this Canadian manufacturer. The nature of these tests (functional, sterility, packaging) indicates laboratory-based studies rather than clinical data from human patients.
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)
This is not applicable as the submission is for a physical medical device and changes to its manufacturing/sterilization, not an AI or imaging diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is established via validated laboratory testing methods and engineering principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used for clinical studies involving multiple readers for diagnostic accuracy, which is not the nature of this submission. The tests performed are laboratory validations against established standards.
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. This device is a physical marker, not an AI or imaging system. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed is based on:
- Functional performance: Observational assessment during device operation to detect debris or abrasion.
- Sterility: Quantitative measurement against ISO 11137-1 and -2:2006 to achieve a 10⁻⁶ SAL.
- Packaging and Shelf-life: Measurement and testing against ISTA 2A:2008 and ASTM standards (F1980, F2096, F1140) to confirm package integrity over time.
These are objective, standard-based laboratory validations, not ground truth derived from expert medical interpretation or clinical outcomes.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth to establish for this type of device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.