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510(k) Data Aggregation
(68 days)
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.
The EXTREMITY MEDICAL Screw System
The provided text describes a 510(k) submission for the EXTREMITY MEDICAL Screw System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a diagnostic AI/ML device would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set, ground truth) are not applicable to this type of device and submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Comparable pull-out strength and torque to predicate devices. | Bench testing (pull-out strength and torque) was performed and compared to predicate devices. |
| Surgical Technique Verification: Demonstrated suitability through clinical simulation. | Clinical simulations in cadavers were performed to verify the surgical technique. |
| Material Equivalence: Made of similar materials to predicate devices. | Stated: "are made of similar materials" to predicate devices. |
| Design Equivalence: Similar design to predicate devices. | Stated: "have a similar design" to predicate devices. |
| Indications for Use Equivalence: Same indications as predicate devices. | Stated: "have the same indications for use" as predicate devices. |
| Overall Substantial Equivalence: To predicate devices. | "The EXTREMITY MEDICAL Screw System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The "tests" here are bench tests and cadaveric simulations, not clinical trials with human subjects.
- Data Provenance: Not applicable in the context of clinical data provenance. The bench testing and cadaveric simulations would have been performed in a lab setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not a diagnostic tool that requires ground truth establishment by experts in the same way an AI/ML device would. The "ground truth" for mechanical properties would be derived from engineering standards and measurements, and for surgical technique from established surgical practices.
4. Adjudication method for the test set
Not applicable. There was no "test set" in the sense of patient data requiring expert adjudication.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (screw system), not an algorithm.
7. The type of ground truth used
For Bench Testing (pull-out strength and torque): The "ground truth" would be the measured physical properties of the predicate devices based on established engineering test methods and standards.
For Clinical Simulations in Cadavers: The "ground truth" would be the expert assessment of the surgical technique's feasibility and success in relation to the intended use, likely by orthopedic surgeons.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(117 days)
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
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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(141 days)
EXTREMITY MEDICAL SCREW SYSTEM
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.
The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws.
This 510(k) summary describes a medical device, the EXTREMITY MEDICAL Screw System, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of typical AI/software performance evaluation. The document focuses on the regulatory clearance for a physical medical implant.
However, based on the structure of your request and the provided document, I can deduce information related to regulatory acceptance and the studies performed (or not performed) for this physical medical device.
Here's an interpretation framed to address your questions as much as possible, re-interpreting "acceptance criteria" and "study" in the context of a 510(k) submission for a physical implant:
1. A table of acceptance criteria and the reported device performance
For a physical medical device seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is primarily done through showing similar indications for use, design, materials, and equivalent mechanical properties.
| Acceptance Criteria Category (for 510(k) Equivalence) | Reported Device Performance/Comparison (EXTREMITY MEDICAL Screw System) |
|---|---|
| Indications for Use | Identical to predicate devices: "fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsal-phalangeal and metacarpal-phalangeal joints." |
| Device Design | Similar design to predicate devices (two metallic components: Metacarpal (distal) screw and a Lag Screw (proximal), designed to rigidly lock at an angle). |
| Material Composition | Similar materials to predicate devices. (Exact materials not explicitly detailed in summary, but implied to be standard for bone fixation fasteners, likely titanium or stainless steel alloys). |
| Mechanical Properties | Equivalent mechanical properties to predicate devices, verified through bench testing (pull-out strength and torque). |
| Surgical Technique | Verified in clinical simulations (cadavers). |
| Clinical Performance/Safety | No clinical testing performed; substantial equivalence based on nonclinical data. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of image data or an AI algorithm’s test set. For the bench testing, specific sample sizes for pull-out strength and torque tests are not provided in this summary. For clinical simulations in cadavers, the summary does not specify the number of cadavers used.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective data as it relates to clinical or imaging datasets, since no clinical or imaging studies were performed for device performance evaluation. The "data" here refers to bench test results which are typically generated in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. This summary describes a physical implant which establishes "ground truth" through direct measurement (e.g., of mechanical properties) rather than expert interpretation of data. The adjudication of substantial equivalence is done by FDA reviewers based on the engineering and design comparisons provided by the manufacturer.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses of datasets, which is not relevant for the bench testing and cadaveric simulations described for this physical device.
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
- MRMC Study: No. This type of study (MRMC, AI assistance) is completely irrelevant to the submission for this physical medical screw system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the mechanical properties, the "ground truth" would be established by direct physical measurement using calibrated lab equipment for metrics like pull-out strength and torque, and by comparing these values to those of the predicate devices. For surgical technique verification, the "ground truth" would be the successful and safe application of the device in cadaveric models as assessed by trained surgeons.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical implant.
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