(30 days)
The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.
The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.
This document is a 510(k) summary for a Special 510(k) submission, focusing on a modification to an already cleared medical device, the Bioretec ActivaPin™ Product Group. As such, the purpose of this submission is to demonstrate substantial equivalence to previously cleared devices, rather than to present a de novo study with acceptance criteria and a detailed study report for new device performance.
Therefore, many of the requested items (e.g., specific acceptance criteria, detailed study results proving the device meets those criteria, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document. The submission relies on the prior clearance of the predicate devices for performance, safety, and effectiveness.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This is a Special 510(k) for a modification (adding a new trade name and a minor design change) to an already cleared device. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate devices, not to a new performance study against specific metrics. The document states: "The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. ... The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness."
2. Sample size used for the test set and the data provenance
Not applicable. No new clinical or performance test set data is presented for this Special 510(k) in the provided summary. The substantial equivalence argument relies on the existing clearances and the minimal nature of the modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is discussed in this Special 510(k) summary.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is discussed.
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 bioabsorbable fixation pin, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical fixation pin, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new ground truth is established for this Special 510(k) submission. The safety and effectiveness are supported by the substantial equivalence to predicate devices, which would have had their performance and safety established through prior studies (not detailed in this document). The device itself (a bioabsorbable pin) is evaluated based on its mechanical properties, biocompatibility, and degradation characteristics, often through bench testing and sometimes animal or clinical studies for initial clearance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.