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510(k) Data Aggregation
(84 days)
The Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.
The Extremity Medical IP Fusion System is designed to allow arthrodesis of the interphalangeal joints of the hand. The system has two intra-operative configurations: a cannulated or non-cannulated lag screw, and an intramedullary Post for engaging the lag screw. The Post consists of a threaded cylinder with an eyelet through the head at to accommodate the lag screw. The axis of the eyelet and the lag screw couple at an oblique angle, which forms a reference angle for the intended fusion. The system includes common instrumentation for application of surgical bone screws within the human body, such as drills, guide wires, countersinks, reamers, drill and guide wire guides, and a screwdriver.
The provided text describes the EXTREMITY MEDICAL IP Fusion System, a device intended for arthrodesis of the interphalangeal joints of the hand. However, it does not explicitly state acceptance criteria in the form of quantitative performance metrics, nor does it detail a study that "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, materials, indications for use, and mechanical properties. The "study" mentioned primarily consists of non-clinical bench testing and clinical simulations in cadavers.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for device performance. The "reported device performance" is described qualitatively as being "substantially equivalent" to predicate devices, based on the testing performed.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Pull-out strength | Performed and compared to predicate devices; found to have equivalent mechanical properties. |
| Torque | Performed and compared to predicate devices; found to have equivalent mechanical properties. |
| Static bending | Performed and compared to predicate devices; found to have equivalent mechanical properties. |
| Dynamic bending | Performed and compared to predicate devices; found to have equivalent mechanical properties. |
| Surgical Technique Verification: | Performed in cadavers to verify the surgical technique. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing: Not specified.
- Sample Size for Cadaver Simulations: Not specified.
- Data Provenance: The testing was conducted by Extremity Medical. The document does not specify country of origin for the data or whether the data was retrospective or prospective, though bench testing and cadaver simulations are by nature prospective for the purpose of device evaluation.
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. The "ground truth" for mechanical testing would be engineering standards and for cadaver simulations, it would be the successful application of the surgical technique. No external experts for "ground truth" establishment are mentioned.
4. Adjudication Method for the Test Set
- An adjudication method is not described, as the testing involves direct measurement and observation rather than expert consensus on complex interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical implant, not a diagnostic or AI-assisted interpretation tool. The document explicitly states: "No clinical testing was performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The EXTREMITY MEDICAL IP Fusion System is a medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For bench testing: Engineering specifications and comparison against predicate device performance serve as the "ground truth" for mechanical properties.
- For cadaver simulations: Successful demonstration of the surgical technique and proper device placement within anatomical structures serves as the "ground truth."
8. The Sample Size for the Training Set
- This concept is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
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