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The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion

The subject system (Pitkar Spinal Pedicle Screw) attaches to the spine through screw, rod, and crosslink components. Furthermore, the system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. All implants are manufactured from Ti-alloy per ASTM F136.

This submission is for a medical device (Pitkar Spinal Pedicle Screw System), not a software or AI device. Therefore, the requested information on acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable and is not present in the provided text.

The document describes the regulatory review and clearance of a Pitkar Spinal Pedicle Screw System, a physical medical device. The clearance is based on its substantial equivalence to existing legally marketed predicate devices.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical and material testing, not clinical trials or AI/software performance studies.

Here's a breakdown of what is available in the document regarding how the device meets its "acceptance criteria" (which in this case are related to safety and performance through substantial equivalence):

Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this physical device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM standards for mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance
There is no specific table of "acceptance criteria" with numerical performance metrics provided in the document for the device itself. Instead, the performance is demonstrated by:

2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a physical device, this would typically refer to the number of device samples tested in laboratory settings, not patient data sets. The provenance would be the testing facility.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable for this type of device submission. Ground truth here is established by engineering and materials science principles and adherence to standards.

4. Adjudication Method for the Test Set:
Not applicable for this type of device submission. Adjudication methods are typically for clinical data or expert reviews, not mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
Not applicable. This is a physical implant device, not a software algorithm.

7. Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:

• Mechanical Testing Results: Performance against established ASTM standards (ASTM F1717 for static compression bending, dynamic compression bending, and static torsion).
• Material Compatibility and Specifications: Conformance to ASTM F136 for Ti-alloy.
• Substantial Equivalence: Comparison of design features, intended use, indications for use, and function to existing cleared predicate devices.

8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no "training set" in the context of this physical device.

In summary, the provided document is a 510(k) clearance letter for a Class II spinal implant device. The "proof" it meets "acceptance criteria" lies in demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM mechanical testing standards.

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The Pitkar Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware.

1. Open and closed fracture fixation
2. Pseudoarthrosis or non-union of long bones
3. Limb lengthening by epiphyseal or metaphyseal distraction
4. Correction of bony or soft tissue deformities
5. Correction of segmental or nonsegmental bony or soft tissue defects
6. 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 Sixafix System. The Pitkar Sixafix System includes a web based software that is designed to assist the physician in performing precise deformity or fracture reduction and should always be used with hardware. The Sixafix System software receives inputs from measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity. To guide the surgeon, detailed information is provided in Software manual. The implantable components are manufactured from Stainless Steel per ASTM F138. The system will be provided in non-sterile configuration and will require steam sterilization prior to use.

This looks like a 510(k) premarket notification for a medical device called the "Pitkar Sixafix System," which is a metallic bone fixation appliance. The document describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria, specific device performance metrics (like sensitivity, specificity, accuracy), or any details about a clinical study involving human or even simulated test sets to prove the device meets acceptance criteria in the way you've outlined for an AI/software-based device.

This document focuses on:

• Device Description: A web-based software to assist physicians with deformity/fracture reduction, used with hardware (implants made of Stainless Steel and appliances from Aluminium).
• Indications for Use: Broad orthopedic applications for adults, children (3-12), and adolescents (12-21) where growth plates are fused or not crossed.
• Predicate Device: Smith & Nephew Inc. - Taylor Spatial Frame (K970748).
• Technological Characteristics: Similar design features, materials, and sterilization to the predicate device.
• Non-Clinical Tests:
  • Software Verification and Validation: Mentions FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This generally refers to testing the software's functionality, reliability, and security, not its diagnostic accuracy or clinical effectiveness in a statistical sense.
  • ASTM F1541-02: Standard Specification and Test Methods for External Skeletal Fixation Devices, covering mechanical tests like bending, axial load, and torsion. This assesses the physical hardware components, not the software's performance.
  • Biocompatibility: Stated to meet ISO 10993-1 due to using commonly available materials with a long history of clinical use.

Therefore, based only on the provided text, I cannot complete your requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or comparative effectiveness for an AI/software device's diagnostic or clinical performance.

The "software" component appears to be a tool for calculating adjustments for a physical fixator based on physician measurements, rather than an AI/ML algorithm performing analysis or diagnosis from medical images or data. The "Software Verification and Validation" mentioned would likely pertain to ensuring these calculations are correct and the software functions as intended, not a statistical evaluation of diagnostic accuracy or clinical impact against a ground truth.

If this were an AI/ML device, the FDA would typically require a much more detailed clinical or performance study section with specific metrics and methodologies. This document is typical of a hardware device with a software component that aids in calculation/planning, rather than a diagnostic AI.

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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

1. For Adult Assembly: Population to be adult males and females for given indications
2. For Pediatric Assembly: Population to be between age of 5 to 10 for given indications
3. 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

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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Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

The purpose of this submission is to request clearance for the new Pitkar Locked Plating System. The Pitkar Locked Plating System implants are designed to address fractures of the humerus, radius, ulna, femur, tibia, fibula, and clavicle. The system is comprised of plates, screws and instruments to facilitate the installation of the implants. The plates and screws are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

This document is a 510(k) summary for the Pitkar Locked Plating System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for an AI/algorithm-based device.

Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves an AI/algorithm-based device meets the acceptance criteria. The document describes a metallic bone fixation appliance, which is a physical medical device, not a software or AI product.

The relevant sections of the document discuss:

• Device Description: Plates, screws, and instruments manufactured from Titanium Alloy for fixation of fractures.
• Performance Data (Nonclinical): This refers to mechanical testing of the physical implants, such as bend tests for plates and torsional/pull-out tests for screws, against ASTM standards. It also mentions biocompatibility.
• Comparison to Predicate Devices: The rationale for substantial equivalence is based on similarities in design, materials, and sterilization to existing marketed devices.

There is no mention of:

• AI or algorithms
• Test sets, training sets, or data provenance
• Experts establishing ground truth for image analysis
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone algorithm performance
• Effect size of human readers with/without AI assistance

In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and study proving an AI/algorithm-based device meets those criteria.

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The Pitkar External Fixation System is indicated for both adults and pediatric patients for:

1. Open and closed fracture fixation
2. Pseudoarthrosis or non-union of long bones
3. Limb lengthening by epiphyseal or metaphyseal distraction
4. Correction of bony or soft tissue deformities
5. Correction of segmental or nonsegmental bony or soft tissue defects
6. 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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The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants < 10 kg who require breathing support due to conditions associated with prematurity or other conditions where CPAP is required or desired and is prescribed by a physician.

Not Found

I'm sorry, but relevant information is not available in the provided context for the given request.

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DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; All cements can also be used as temporary filling materials

Provi Cem Esthetic consist of three different cements: DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; All cements can also be used as temporary filling materials

This document, specifically the "Summary of Safety and Effectiveness" for Provi Cem Esthetic, is a 510(k) premarket notification. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Instead, this document focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device). In the context of 510(k) submissions, the manufacturer, S&C Polymer Silicon- und Composite Spezialitaeten GmbH, is asserting that their new device (Provi Cem Esthetic) is as safe and effective as the predicate device (Tempbond Clear, K982590) without the need for new clinical studies to prove performance against specific acceptance criteria.

The information provided confirms the following:

• Device Name: Provi Cem Esthetic (consisting of DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F, and DC Provi Cem Implant)
• Intended Use:
  • DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Cementing temporary restorations (crowns, bridges, inlays, onlays) and trial cementing permanent restorations.
  • DC Provi Cem Implant: Cementing semi-permanent implants.
  • All cements can also be used as temporary filling materials.
• Predicate Device: Tempbond Clear, K982590.
• Reason for Submission: Demonstrating substantial equivalence to a legally marketed device.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, or study results because this document does not contain that information. The 510(k) pathway often relies on comparison to existing devices rather than new performance studies against pre-defined acceptance criteria, especially for Class II devices like dental cements.

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System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner, DC Canal Seal SE, and DC Root XR.
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation.
DC Canal Seal SE is a simple to use selfetching dual cure sealer for conditioning of root canals and for sealing of side tubuli.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.

System for cleansing, sealing and filling of root canals consisting of 3 products: Canal Cleaner, DC Canal Seal SE, and DC Root XR.
Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes.
DC Canal Seal SE is a selfetching dual cure sealer.
DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.

The provided text is a 510(k) clearance letter from the FDA for a dental device called "Root Canal XR". This letter grants clearance based on substantial equivalence to a predicate device. It addresses regulatory compliance rather than presenting clinical study results with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set information cannot be extracted from this document.

This document primarily:

• States the device name and regulation number.
• Confirms substantial equivalence to a predicate device.
• Outlines general regulatory requirements for the manufacturer.
• Specifies the "Indications for Use" for the three products comprising the Root Canal XR system (Canal Cleaner, DC Canal Seal SE, and DC Root XR).

There is no mention of performance metrics, clinical studies, or criteria for device acceptance in terms of efficacy or safety data in this clearance letter.

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PhoGlass Cem is intended to be used as an insoluble cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.

PhoGlass Cem is a dental glass ionomer cement intended to be used as an cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.

The provided document is a 510(k) premarket notification for a dental cement called PhoGlass Cem. This type of notification focuses on demonstrating substantial equivalence to a predicate device rather than on presenting extensive clinical study data and performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

Instead, the document primarily establishes:

• Device Name: PhoGlass Cem
• Intended Use: Cementing crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands, and as a base or liner.
• Predicate Device: Fuji I (GC Corporation)
• Substantial Equivalence Claim: PhoGlass Cem functions similarly and has the same intended use as the predicate device.

Without the specific clinical or performance study data, I cannot populate the requested table and answer the detailed questions.

Here is an explanation of why the requested information is absent from this specific type of document:

• 510(k) Premarket Notification: This regulatory pathway is used for medical devices that are substantially equivalent to a legally marketed predicate device. The primary focus is on demonstrating this equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through bench testing and comparison to the predicate, rather than through new, large-scale clinical trials that would generate the detailed performance metrics requested.
• Type of Device: A dental cement is a material, and its performance is typically evaluated through physical and chemical properties (e.g., compressive strength, film thickness, solubility) rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
• Content of the Document: The provided text is the "Summary of Safety and Effectiveness" and the FDA's clearance letter. Neither of these sections would typically include the detailed study methodology or comprehensive performance results that you've asked for, especially for a device of this nature undergoing a 510(k) clearance.

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System for the restoration of cavities, also suitable for , core-build-up- and sealing applications. Conditioning of dentin and enamel and protecting of restored areas.

PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class | III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups.

PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings.

PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root surface protection, for fissure protection and for interroediate restorations of lesions.

PhoGlass Prime is intended to be used as a conditioner for dentin and enamel to enhance the bond between the cements and the tooth structure.

PhoGlass Protect is intended for protecting PhoGlass restorations from exposure to moisture.

PhoGlass is a system consisting of a Glass lonomer restorative dental material suitable for restorative, core build-up-, and sealing-purposes. In addition it contains a dentinel engmel conditioner and a liquid suitable for protective coatings of the restorations

The provided text K082115 is a 510(k) premarket notification for a dental material and does not contain the information requested in the prompt regarding acceptance criteria, study details, and performance metrics.

The document primarily focuses on:

• Identification of the device: PhoGlass (Fill, Core, Seal, Prime, Protect)
• Classification: Dental Cement (21CFR § 872.3275)
• Intended Use: Restoration of cavities, core build-up, sealing, conditioning, and protective coatings.
• Substantial Equivalence Claim: To legally marketed predicate devices (Fuji IX GP Extra, Fuji VII, GC Dentin Conditioner, GC Fuji Varnish).
• Regulatory information: FDA's substantial equivalence determination, regulation numbers, contact information.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study to prove meeting those criteria based on the provided text. The prompt asks for information that is typically found in a clinical study report or a detailed pre-clinical testing summary, none of which is present in the given 510(k) summary.

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