(15 days)
The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures
- Fracture management in the foot or hand
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- Treatment of inferior tibio fibular diastasis
- Hindfoot arthrodesis
The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Weil osteotomy
- Fusion of the first metatarsophalangeal joint and interphalangeal joint
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Calcaneus/ cuboid arthrodesis
- Talar/ navicular arthrodesis
The DARCO® Headless Compression Screw is manufactured from Titanium Alloy conforming to ASTM F136. The screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.
This document, K080850, is a 510(k) summary for the DARCO® Headless Compression Screw. This type of submission is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
Crucially, this document does not describe a clinical study with acceptance criteria and device performance results in the way you might expect for a diagnostic or AI-based device.
Instead, the "study" demonstrating the device meets acceptance criteria in a 510(k) for a medical implant like a screw typically involves demonstrating substantial equivalence to a predicate device. This is achieved through:
- Design features comparison: Showing the new device has similar design principles to the predicate.
- Material information: Confirming the materials used are common, biocompatible, and have established properties (e.g., Titanium Alloy conforming to ASTM F136).
- Analysis data: This usually refers to non-clinical, benchtop testing to evaluate mechanical properties (e.g., strength, compression, fatigue) against established standards or in comparison to the predicate device. These tests aim to ensure the device performs its intended function safely and effectively within expected physiological loads.
Therefore, many of your requested items for AI/diagnostic studies are not directly applicable to this type of submission. I will answer what is inferable from the document and explicitly state when information is not present.
1. Table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria and reported device performance in the context of a clinical study or performance metrics for a diagnostic algorithm. For a 510(k) for a surgical implant, the "acceptance criteria" are typically met by demonstrating that the device is substantially equivalent to a predicate device through:
- Material conformity: The device uses Titanium Alloy conforming to ASTM F136. This is a common and accepted material for medical implants, implicitly meeting acceptance for biocompatibility and mechanical properties as per the standard.
- Design similarities: The design features are stated to be "substantially equivalent" to a previously cleared predicate device.
- Performance via analysis data: "Analysis data" is mentioned as supporting safety and effectiveness. This would refer to non-clinical tests (e.g., mechanical testing, biocompatibility testing) that demonstrate the device performs as intended and meets relevant engineering and safety standards, comparable to the predicate. Specific numerical criteria or results are not provided in this summary.
| Acceptance Criteria (Inferred for Mechanical Implant) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Material meets recognized standards for medical implants (e.g., ASTM F136 for Titanium Alloy). | Manufactured from Titanium Alloy conforming to ASTM F136. |
| Design features are comparable to a legally marketed predicate device and support the stated indications for use. | Design features are "substantially equivalent to previously cleared predicate device." |
| Mechanical performance (e.g., strength, compression, fatigue) is sufficient for intended use and comparable to predicate, as demonstrated by non-clinical analysis. | Safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data." (Specific numerical results from these analyses are not provided in this summary, but would have been part of the full 510(k) submission and compared against internal or standard acceptance limits. The FDA's clearance indicates these were met.) |
Regarding the Absence of Information for AI/Diagnostic Study Elements:
The following items are not applicable or findable in this 510(k) summary because it is for a physical medical implant (a screw), not a diagnostic device or an AI-based system. Therefore, details about test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not relevant to this submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable: This is a physical implant, not a diagnostic or AI device that utilizes a test set of data. The "testing" involved non-clinical mechanical and material analyses.
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: No clinical test set with ground truth established by experts is mentioned for this device. Ground truth, in a sense, would be conformance to engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set requiring adjudication is mentioned.
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 surgical screw, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a surgical implant; there is no algorithm or standalone performance in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional sense: For this device, "ground truth" for demonstrating safety and effectiveness involves compliance with material standards (ASTM F136), mechanical testing results (which would typically be compared to established benchmarks or predicate device performance), and successful demonstration of substantial equivalence to a predicate device.
8. The sample size for the training set
- Not Applicable: There is no "training set" for a physical medical implant.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
§ 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.