(79 days)
The purpose of the device is to hold, with sutures, the soft tissue against the bone for a prescribed healing period. This device is to be used for soft tissue attachment in the shoulder, ankle, foot, wrist, hand, elbow, knee and pelvis. This present submission is being made to introduce an additional indication for use in soft tissue reconstruction following total hip arthroplasty.
The Howmedica Mainstay™ Soft Tissue Anchor is a titanium alloy self-drilling, selftapping cancellous screw threaded device for the attachment of soft tissue to bone. The device is available in three sizes and has a proximal thru-hole for the attachment of the desired suture material.
This 510(k) summary for the Howmedica Mainstay™ Soft Tissue Anchor Device does not contain the level of detail required to answer all the questions comprehensively. It focuses on demonstrating substantial equivalence to a predicate device for an additional indication for use, rather than detailing a specific clinical study with acceptance criteria, expert ground truth, or AI performance metrics.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states: "Results of this testing indicated that the initial fixation strength of the Mainstay™ Soft Tissue Anchor did not differ significantly from that of the Mitek SuperAnchor when used in the same anatomic site."
This implies the acceptance criterion was likely non-inferiority in initial fixation strength compared to the predicate device (Mitek SuperAnchor).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Initial fixation strength non-inferior to Mitek SuperAnchor | "did not differ significantly from that of the Mitek SuperAnchor when used in the same anatomic site." |
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 the sample size used for the test set (number of anchors tested, number of anatomical sites, etc.). It also does not mention the data provenance (country of origin or whether it was retrospective/prospective). The testing appears to be primarily mechanical/bench testing based on the "Guidance for Testing - April 20, 1996" which is generally for device performance rather than clinical data.
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 information is not provided. Given the nature of the device (implantable anchor) and the type of testing suggested by "fixation strength," it's highly unlikely that "experts" in the sense of clinical reviewers established ground truth for a test set. This would typically involve mechanical engineers, biomechanical testing facilities, and potentially surgeons for anatomical relevance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable or not mentioned. Adjudication methods are typically used for clinical data interpretation or image review, which is not described here.
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 mechanical implant, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for demonstrating substantial equivalence for this device appears to be based on biomechanical testing data measuring material properties and device performance (specifically "initial fixation strength") according to established FDA guidance for bone anchor devices. The predicate device (Mitek SuperAnchor) served as the comparator for this "ground truth."
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm requiring a training set. If the question refers to design verification/validation testing during development, that information is not provided.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of medical device.
§ 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.