(28 days)
The BONE-LOK® MVP Cortical-Cancellous Compression Device is indicated for use in the general management of fractures and reconstructive surgery.
The BONE-LOK® MVP Cortical-Cancellous Compression Device is a double-helix screw with a compression-locking collar. It is available as 3.5mm or 4.5mm diameter device with a compression looking ochan 1978 - The BONE-LOK® MVP Cortical-Cancellous Compression Device is intended for single use only. Devices provided "STERILE" are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BONE-LOK® MVP Cortical-Cancellous Compression Device, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet requirements of ASTM F-138 (stainless steel) or ASTM F-136 (titanium). | Materials meet ASTM F-138 (stainless steel) or ASTM F-136 (titanium). |
| Functional Performance | Satisfy functional performance requirements when used as indicated. | Performance test results indicate the device is safe and satisfies functional performance requirements. |
| Substantial Equivalence | Demonstrates substantial equivalence to the predicate device. | Test results demonstrate substantial equivalence to the predicate device. |
Explanation of "Acceptance Criteria" in this Context:
It's important to note that the provided 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a detailed list of specific numerical acceptance criteria for clinical or performance outcomes. The acceptance criteria here are implicitly:
- The materials used are biocompatible and commonly accepted for orthopedic devices.
- The mechanical performance is comparable to the predicate device.
- The device is safe for its intended use.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set with human or animal subjects, nor does it mention sample sizes for such a set. The document refers to "Performance test results" which are likely referring to mechanical or bench testing.
- Sample Size for Test Set: Not mentioned, likely not applicable in the context of human/animal outcome data for this type of submission.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As there's no mention of a clinical test set requiring human interpretation or ground truth establishment in the traditional sense (e.g., for diagnostic accuracy), this section is not applicable.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable, as there's no mention of a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study (often seen in diagnostic imaging for AI) is not relevant for a bone fixation device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical bone fixation screw, not a software algorithm or AI tool. Therefore, a "standalone algorithm performance" study is not relevant. The "performance data" mentioned refers to mechanical testing.
7. Type of Ground Truth Used
Based on the document, the "ground truth" for the device's performance is established through:
- Compliance with Material Standards: Meeting ASTM F-138 (stainless steel) or ASTM F-136 (titanium) for biocompatibility. These are established industry standards for medical-grade materials.
- Mechanical Performance Bench Testing: The statement "Performance test results indicate that the device is safe and satisfies functional performance requirements" implies benchtop mechanical testing (e.g., strength, compression, fatigue) against established engineering specifications or comparison to the predicate device's known performance.
- Substantial Equivalence to Predicate Device: The ultimate "truth" for 510(k) clearance is demonstrating that the modified device is as safe and effective as a legally marketed predicate device.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI model or software algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.