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510(k) Data Aggregation
(149 days)
Pitkar External Fixation System - Rail Mechanism
Pitkar External Fixation System- Rail Mechanism consist of Rail Fixation System and ALFA Fixator System. Their components are intended to be used on adult or pediatric patients as required.
A. Rail fixation System
1.Fracture fixation
2.For correcting diaphyseal deformities. metaphyseal deformities with or without shortenings
3.Correction of bony or soft tissue deformities
4.Limb Lengthening
5.For treating non-union and mal-union
6.Bone transport application
B. ALFA Fixator System
1.Open and closed fracture fixation
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction:
3.Pseudoarthrosis of long bones;
4.Limb lengthening;
5.Infected fractures or non-unions; and
6.Correction of long bone deformities.
Note: For Rail Fixation System and ALFA Fixator System
- For Adult Assembly: Population to be adult males and females for given indications
- For Pediatric Assembly: Population to be between age of 5 to 10 for given indications
- It is recommended to avoid operating on children under the age of five, in case of pediatric application
Pitkar External Fixation System- Rail Mechanism. The subject application has two devices covered that fall under Rail fixation category. Both the systems have Adult & Pediatric apparatus. Both the systems have different Rail design & clamps design. They are designated as: 1. Rail Fixation System 2. Alfa Fixator System Thus, there will be two subject devices for approval under this heading as both these systems have same application, device description, Indications, material composition etc.
This document describes the 510(k) premarket notification for the "Pitkar External Fixation System - Rail Mechanism." This device is intended for orthopedic procedures such as fracture fixation, deformity correction, and limb lengthening.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Device Performance (Reported Results) |
|---|---|
| Axial Load Test (ASTM F1541-02) | Demonstrated against applicable standard ASTM F1541-02 |
| Torsion Test (ASTM F1541-02) | Demonstrated against applicable standard ASTM F1541-02 |
| Fatigue Test (ASTM F1541-02) | Demonstrated against applicable standard ASTM F1541-02 |
| Cantilever Bending Test (ASTM F1541-02) | Demonstrated against applicable standard ASTM F1541-02 |
| 4-Point Bending Test (ASTM F1541-02) | Demonstrated against applicable standard ASTM F1541-02 |
| Biocompatibility (ISO 10993-1) | Meets ISO 10993-1 standard requirements; no further testing required. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test. It mentions that the device performance was "demonstrated against applicable standards ASTM F1541-02" for mechanical tests and "meets the ISO 10993-1 standard requirements" for biocompatibility.
The data provenance is retrospective, as the justification for biocompatibility relies on the device being comprised of "the same material and have the same manufacturing, body contact, and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants." The mechanical tests are also non-clinical and performed under controlled laboratory conditions rather than on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the described tests are non-clinical engineering and materials tests, not studies involving expert medical interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable as the described tests are non-clinical engineering and materials tests, not studies requiring adjudication of various expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (external fixation system), and the performance evaluation is based on non-clinical mechanical and biocompatibility testing, not on human interpretation of images or data.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done. This submission is for a physical medical device, not an algorithm or AI software. All tests conducted were on the physical components of the device.
7. Type of Ground Truth Used
The ground truth used for the performance evaluation consists of established engineering standards and material science principles.
- For mechanical tests (Axial Load, Torsion, Fatigue, Cantilever Bending, 4-Point Bending), the ground truth is adherence to the specifications and performance requirements outlined in ASTM F1541-02.
- For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1 and the demonstrated safe use of similar materials in predicate devices.
8. Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set. The device's performance is not learned from data but inherent in its design, materials, and manufacturing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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(230 days)
Pitkar External Fixation System
The Pitkar External Fixation System is indicated for both adults and pediatric patients for:
- Open and closed fracture fixation
- Pseudoarthrosis or non-union of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformities
- Correction of segmental or nonsegmental bony or soft tissue defects
- Post-Traumatic joint contracture which has resulted in loss of range of motion
The purpose of this submission is to request clearance for the new Pitkar External Fixation System. The implantable components are manufactured from Stainless Steel per ASTM F899. The system will be provided in non-sterile configuration and will require to be steam sterilized by the user prior to use.
The provided text is a 510(k) summary for the Pitkar External Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing. However, it does not include information about acceptance criteria or a study proving that a device meets those criteria, especially in the context of an AI/ML-based device.
Instead, this document focuses on demonstrating substantial equivalence through non-clinical performance and similarity to predicate devices, which is a common regulatory pathway for medical devices that are not AI/ML-based.
Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, the performance of such a device, sample sizes, ground truth establishment, or human reader effectiveness from this document. The document explicitly states "Clinical Tests: o N/A," indicating no human clinical trials were conducted for this submission.
If you have a document pertaining to an AI/ML device with details of its validation study, I would be happy to analyze it for the requested information.
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