(204 days)
The LAKI device is intended to be used for fixation of bone fractures of long bones in fingers. The LAKI device is a semi-invasive device intended to be attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
This 510(k) consists on the submission of an evolution of an external fixation device. The LAKI Hand Fixation System provides opportunity to patients to develop solid bone re-growth in cases of fractures, pseudo-arthrosis, and limb lengthening by use of modular elements, rods, and nuts. The LAKI utilizes a threaded rod bound to two semi modular elements with nuts which allows the former to be locked in the most suitable position for each specific case. Kirschner wires are also used for stabilization. All invasive components of the LAKI Hand Fixation System are made of 316L stainless steel. External locking connector components are all made of Ti6AL4V titanium alloy.
The provided text is a 510(k) summary for the LAKI Hand Fixation System. It describes the device, its indications for use, and claims substantial equivalence to a predicate device (LIMA SEM Modular External Stabilizer, K880282). Crucially, the document states under "V. Performance Data": "Please see 510(k) submission for the SEM Modular External Stabilizer, K880282."
This means that a separate document (K880282) would contain the performance data, acceptance criteria, and details of any studies proving the device meets those criteria. The current document (K082679) does not include this information directly.
Therefore, I cannot provide the requested table and study details based solely on the provided text. The document explicitly defers to the predicate device's 510(k) for performance data.
Based on the provided text for K082679, I can only state the following:
1. A table of acceptance criteria and the reported device performance:
- Not available in the provided text. The document directs to K880282 for performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in the provided text. The document directs to K880282 for performance 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):
- Not available in the provided text. The document directs to K880282 for performance data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in the provided text. The document directs to K880282 for performance data.
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 is a hardware medical device (fixation system), not an AI-assisted diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available in the provided text. The document directs to K880282 for performance data.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a hardware medical device, not a machine learning algorithm.
To answer your request comprehensively, one would need to access and review the 510(k) submission for the LIMA SEM Modular External Stabilizer (K880282).
§ 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.