Search Results
Found 5 results
510(k) Data Aggregation
(83 days)
WALTER ABENDSCHEIN, M.D.
The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows :
- Congenital coxa vara.
- Congenital dislocation of the hip
- Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
- Coxa plana ( Legg-Calve-Perthes disease )
The VHS™ Pediatric Hip Screw System is a compression fixation system used for the treatment of femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws. Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
The provided text is a summary of a 510(k) premarket notification for the VHS™ Pediatric Hip Screw System. This document focuses on establishing substantial equivalence to existing devices, which is a regulatory pathway for medical devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or technical validation study would for an AI/ML device.
The 510(k) process for this type of medical device generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, and that any differences do not raise new questions of safety or effectiveness. Performance data would typically involve mechanical testing to ensure material strength and functional integrity, but these specific details are not provided in this summary.
Therefore, I cannot fulfill your request for information related to acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, or AI/ML specific evaluations (such as MRMC studies, standalone performance, or ground truth establishment for training data). This document is not the appropriate source for such information.
Ask a specific question about this device
(128 days)
WALTER ABENDSCHEIN, M.D.
Ask a specific question about this device
(101 days)
WALTER ABENDSCHEIN, M.D.
Ask a specific question about this device
(72 days)
WALTER ABENDSCHEIN, M.D.
The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.
The VHS™ Supracondylar Plate System is a compression fixation system used for the treatment of distal femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
The provided text describes a 510(k) premarket notification for the VHS™ Supracondylar Plate System, a device used for treating distal femoral fractures. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone AI performance evaluations.
Therefore, many of the requested categories are not applicable to a 510(k) submission for a medical device that isn't an AI/ML product. The document focuses on demonstrating that the new device has "no significant differences" to existing predicate devices in terms of design, function, material, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed results from a test set.
Here's an attempt to address the points based on the provided text, indicating "Not Applicable" where the information is not present or relevant to a 510(k) for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a mechanical implant (supracondylar plate system) and not an AI/ML diagnostic device, there are no specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) for the device's performance in the way an AI algorithm would be evaluated. The "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially the finding of substantial equivalence.
| Acceptance Criteria (for 510(k) Approval) | Reported Device Performance (as determined by FDA) |
|---|---|
| Device is substantially equivalent to legally marketed predicate devices in design, function, material, and intended use, with no significant differences that would adversely affect use. | The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or to reclassified devices. The FDA found "no significant differences... which would adversely affect the use of the product." |
2. Sample size used for the test set and the data provenance: Not Applicable.
This is not an AI/ML diagnostic device. The substantial equivalence determination is based on a comparison of device characteristics to predicate devices, not on a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable.
No test set requiring expert ground truth was used for this type of submission.
4. Adjudication method for the test set: Not Applicable.
No test set or adjudication process for ground truth was involved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not Applicable.
This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not Applicable.
This is not an algorithm.
7. The type of ground truth used: Not Applicable.
For a 510(k) for a medical device like this, the "ground truth" for substantial equivalence is regulatory comparison to existing devices and standards, rather than clinical outcomes or pathology data from a new study.
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.
Ask a specific question about this device
(315 days)
WALTER ABENDSCHEIN, M.D.
The Vari-Angle Hip Screw is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.
The Vari-Angle Hip Screw System is a compression hip fixation system used for the treatment of femoral neck fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
The provided text is a 510(k) summary for the Vari-Angle Hip Screw System, a medical device used for treating femoral neck fractures. This type of submission to the FDA focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a detailed clinical study with acceptance criteria and performance data in the way one would for a novel algorithm or diagnostic device.
Therefore, the specific information requested in the prompt (acceptance criteria, detailed study design, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not present in this document. The 510(k) process for this device type primarily relies on demonstrating material and design similarity to already approved devices.
Here's a breakdown of why the requested information isn't available in this document:
- Acceptance Criteria & Device Performance Table: This document does not describe specific numerical performance metrics or acceptance criteria for the Vari-Angle Hip Screw System. Instead, it asserts "no significant differences" in technological characteristics compared to predicate devices.
- Sample Size (Test Set) & Data Provenance: There is no mention of a test set, clinical data, or sample sizes for performance evaluation.
- Number of Experts & Qualifications: Not applicable, as no expert-adjudicated ground truth study is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: This is not a diagnostic device involving human readers or AI. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant and not mentioned.
- Standalone Performance: This is a physical implant, not an algorithm. "Standalone performance" in the context of an algorithm's output does not apply here. The device's function is mechanical and biologically integrated.
- Type of Ground Truth Used: Not applicable, as detailed performance measurement against a ground truth is not the basis of this 510(k) submission.
- Sample Size for Training Set: Not applicable. There is no algorithm or "training set" in the context of this mechanical device.
- How Ground Truth for Training Set was Established: Not applicable.
Instead, the document focuses on:
- Substantial Equivalence: The core of this 510(k) is to prove that the Vari-Angle Hip Screw System is "substantially equivalent" to legally marketed predicate devices (e.g., Free-Lock Compression Hip Fixation System, AMBI Hip Screw System). This means comparing design, function, material, and intended use.
- Predicate Devices: A list of predicate devices is provided.
- Materials: Stated as 316 LVM stainless steel per ASTM standards.
- Function: To provide immediate stability and temporary fixation during healing of femoral neck fractures.
- Intended Use: Specifically listed for various types of femoral fractures and osteotomies.
Conclusion:
The provided 510(k) summary for the Vari-Angle Hip Screw System does not contain information related to acceptance criteria, detailed study designs, sample sizes, expert ground truth, or AI-related performance metrics as requested. This is because it's a submission for a mechanical implant based on substantial equivalence, not a diagnostic device or algorithm requiring such detailed performance study data.
Ask a specific question about this device
Page 1 of 1