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510(k) Data Aggregation
(117 days)
The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.
The EXTREMITY MEDICAL Screw and Washer System is a medical device intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The device received 510(k) clearance (K101700) from the FDA on October 12, 2010.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Similar design, materials, and equivalent mechanical properties to predicate devices. Pull-out strength, torque, and bending performance at least as good as predicate devices. | "Mechanical Testing and calculations have been completed supporting substantial equivalence to the predicate devices listed. The implants in the EXTREMITY MEDICAL Screw and Washer system have a similar design; are made of similar materials, have the same indications for use, and have equivalent mechanical properties. Bench testing, including pull-out strength, torque, and bending, was performed and compared to the predicate devices. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices." |
| Clinical Simulation | Verification of surgical technique in cadavers. | "Clinical simulations in cadavers were performed to verify the surgical technique. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices." |
| Safety and Effectiveness | Constitutes a safe and effective medical device, meeting all declared requirements of its intended use, with no adverse health effects or safety risks. | "The EXTREMITY MEDICAL Screw and Washer System, subject of this submission, as supported by both mechanical testing and clinical simulation, constitutes a safe and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended." |
| Substantial Equivalence | Demonstrates substantial equivalence to predicate devices. | "The EXTREMITY MEDICAL Screw and Washer System performed as well as the predicate devices." (Conclusion); "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." (FDA Letter) |
Study Proving Acceptance Criteria:
The device's acceptance criteria were primarily met through non-clinical bench testing and clinical simulations in cadavers, demonstrating substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for the bench testing (e.g., number of screws/washers tested for pull-out strength, torque, bending). For clinical simulations, it mentions "cadavers," implying a biological sample, but the specific number is not provided.
- Data Provenance: The data provenance is retrospective, as it involves testing performed on the device and comparator devices rather than on human patients in a prospective clinical trial. The country of origin of the data is not explicitly stated but is implied to be within the scope of the submitting company's operations, likely the USA given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The study primarily relies on objective mechanical testing and cadaveric simulations, not expert interpretation of results to establish ground truth in the way it would be for diagnostic imaging.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. "Adjudication method" typically refers to how disagreements are resolved among multiple human reviewers when establishing a ground truth, often in the context of diagnostic studies. The studies performed here (mechanical bench testing, cadaveric simulations) do not involve such a process.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human performance is compared with and without AI assistance. This device is a surgical implant system, not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical implant; it does not have an "algorithm-only" mode. The device's performance is inherently linked to its physical properties and how it's used in a surgical context by a human.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Bench Test Standards: Mechanical properties (pull-out strength, torque, bending) were measured against established engineering standards or direct comparison to the performance of legally marketed predicate devices. The "truth" is that the new device's performance met or exceeded the predicate device's performance.
- Cadaveric Verification: The "truth" in clinical simulation was the successful verification of the surgical technique in cadavers, confirming the device's usability and appropriate mechanical behavior within a biological model.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical implant, not an AI/ML algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As explained above, there is no training set for this type of medical device.
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