(66 days)
The HammerToe Compression System is indicated for use in the stabilization and inter-digital reconstruction of the phalanges of the foot, appropriate for the size of the device.
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerToe Compression System.
The HammerToe Compression System includes two intramedullary bone screws and a strut, which is provided pre-assembled with the proximal screw. Implantable K-wires are also provided in the system. The implants are provided in multiple diameters and lengths to accommodate variations in patient anatomy.
The provided text describes a medical device, the "HammerToe Compression System," and its 510(k) clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical study report.
Instead, the document details physical performance testing of the device to assure substantial equivalence to a predicate device. This type of testing evaluates the mechanical properties of the device itself rather than its performance in detecting or diagnosing a condition, which is what the prompt implies with terms like "accuracy metrics" and "ground truth."
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, reported device performance (in terms of accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or MRMC studies, as this information is not present in the provided text.
Based on the information available, I can only provide the following:
1. A table of acceptance criteria and the reported device performance
The document describes performance testing but does not explicitly state acceptance criteria or provide numerical performance against them for evaluation like sensitivity, specificity, or accuracy. It mentions tests for:
- Static and dynamic bending
- Pullout force
- Insertion/removal torque
- Torque to failure
The conclusion states: "Performance testing demonstrates the substantial equivalence of the HammerToe Compression System to the HammerTube® System." This implies successful completion of these mechanical tests against established benchmarks or comparative performance to the predicate device, but the specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance
The document does not mention the sample size for a "test set" in the context of diagnostic performance. It refers to "representative HammerToe Compression System components" for physical performance testing, implying a hardware test, not a data-driven clinical test. No data provenance (country of origin, retrospective/prospective) is applicable here as it's not a clinical study of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not present in the document. The "ground truth" for this device's evaluation is primarily its mechanical integrity and performance, not a diagnostic outcome requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present.
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
This information is not applicable and not present. The device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical performance testing described, the "ground truth" would be established engineering standards, material specifications, and comparative performance against the predicate device. These are inherent physical properties and test outcomes, not clinical ground truth derived from patients or experts.
8. The sample size for the training set
This information is not applicable and not present. There is no training set mentioned, as this is not a machine learning device.
9. How the ground truth for the training set was established
This information is not applicable and not present.
Summary of what the document does provide regarding device evaluation:
The document describes engineering tests performed on the HammerToe Compression System to demonstrate its "substantial equivalence" to a predicate device (HammerTube® System K171715). These tests focus on the mechanical properties and physical integrity of the implantable components. The intent is to show that the device performs as intended and does not raise new questions of safety and effectiveness compared to the already cleared predicate.
The material of the screws and strut is Titanium Alloy, and K-Wires are Stainless Steel. The system is designed for stabilization and inter-digital reconstruction of the phalanges of the foot.
§ 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.