Search Results

The Pediatric Plating Platform | Small-Mini is indicated for internal fracture fixation, osteotomies, mal-unions, and non-unions of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The Pediatric Plating Platform | Small-mini is intended for children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which unfused growth plates will not be compromised by fixation, and adults. If used in the femur, tibia, humerus, patella, or pelvis the Pediatric Plating Platform | Small-Mini can only be used for non-load bearing stabilization and reduction.

The Pediatric Plating Platform | Small-Mini consists of plates and screws in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Small-Mini also includes surgical instruments.

The Pediatric Plating Platform | Small-Mini offers a selection of implantable devices, consisting of straight and shaped plates, and screws specifically designed for the appendicular skeleton appropriate for the implant size. The plates are offered in a variety of shapes (Reconstruction Plate, Strength Plate, T-Plate, L-Plate, Y-Plate, Triangle Plate, Flare Triangle Plate, Distal Radius Plate, Peri-Implant Plate, Mesh Plate, Tubular Plate, Locking Compression Plate, and Hook Plate) and lengths to accommodate the anatomy for fixation of traumatic fractures or following planned osteotomies. The plate is fixed to the bone via the choice of polyaxially locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Small-Mini is available in 2.0, 2.4, 2.7 and 3.5 families providing a suitable range of screw and plate sizes.

The implants of the Pediatric Plating Platform | Small-Mini are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).

N/A

Ask a specific question about this device

The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

The Pediatric Plating Platform | Hip consists of plates, screws and connector bolts in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Hip also includes surgical instruments.

The Pediatric Plating Platform | Hip offers a selection of plates and screws specifically designed for deformity correction and trauma of the proximal femur. Plates are offered in a variety of angles and offsets to accommodate the anatomy following planned osteotomies or fixation of traumatic fractures. The plate is fixed to the bone via the choice of beam, locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Hip is available in infant, child and adolescent families providing a suitable range of screw and plate sizes.

The implants of the Pediatric Plating Platform | Hip are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).

The provided FDA 510(k) clearance letter for the Pediatric Plating Platform | Hip is for a physical medical device (bone plates and screws), not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD (which typically involves metrics like sensitivity, specificity, AUC, human reader studies, etc.) is not applicable to this submission.

The FDA clearance relies on traditional medical device testing and comparisons for physical implants, such as:

• Biocompatibility: Based on the prior use of the OrthoPediatric Corp's Locking Proximal Femur System which shares the same materials, manufacturing, and cleaning processes.
• MR Safety: Evaluated using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, determined to be MR Conditional.
• Mechanical Performance: Included Torsional Properties, Insertion and Removal Torque, Axial Pullout Strength (per ASTM F543), and Static Compression Bending and Fatigue Compression Bending (per ASTM F384). The results demonstrated substantially equivalent mechanical performance to the predicate device.

There is no mention of:

• AI algorithm performance metrics.
• Test sets, training sets, or data provenance for AI models.
• Ground truth established by experts for AI.*
• Multi-reader multi-case (MRMC) studies for AI assistance.
• Standalone AI performance.

In summary, a table of acceptance criteria and reported device performance, sample size, expert qualifications, and adjudication methods for AI/SaMD are not part of this 510(k) submission as it is for a physical orthopedic implant, not an AI software product.

Ask a specific question about this device

Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization and fixation of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained fracture due to trauma or disease. The patient population is pediatric and includes child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients.

Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' Pediatric Nailing Platform | Femur is for single use only.

Pediatric Nailing Platform | Tibia offers a selection of rigid intramedullary nails for internal stabilization of the tibia. When a tibia is broken into multiple pieces, via a traumatic fracture(s), disease, or planned osteotomy(ies), alignment and stabilization of the bone fragments is critical to ensuring successful healing. When inserted down the intramedullary canal and locked with screws both proximally and distally, a rigid metallic nail provides resistance to bending and axial loading of the bone. In cases where compression is desired to stimulate bone regeneration, a dynamization slot can be utilized. End caps may be implanted with the nail, to ease removal by protecting the proximal threads of the nail and prevent bony ingrowth, as well preventing incarceration of the nail. All implants are single use and are made of Ti-6Al-4V ELI. The Pediatric Nailing Platform | Tibia was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class II and Class I exempt instruments.

Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. Pediatric Nailing Platform | Femur also offers end caps which are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class II and Class I exempt instruments.

The provided FDA 510(k) clearance letter for the OrthoPediatrics Pediatric Nailing Platform (Tibia and Femur) addresses a "Special 510(k)" submission. A Special 510(k) is typically used for changes to a manufacturer's own legally marketed device where the modification does not affect the device's indications for use or its fundamental scientific technology.

Based on the document, the key changes are related to sterilization, shelf life, and packaging. The performance data section explicitly states:

"The sterility, shelf life as well as the packaging of the subject sterile devices were supported by the sterilization validation and the packaging validation which includes aging and simulated transport."

And:

"An engineering analysis has been conducted that there is no impact of sterilization or aging on the products' performance and functionality."

This context is crucial because the "study that proves the device meets the acceptance criteria" in this case is not a clinical study involving human patients, but rather non-clinical performance testing focused on the impact of these manufacturing changes.

Therefore, the requested information about AI model performance, multi-reader multi-case studies, expert consensus for ground truth, and training set details are not applicable to this specific 510(k) submission. This is not a software-driven diagnostic device; it is a physical, implantable medical device.

Here's how to interpret the request in the context of this document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify exact sample sizes for the "sterilization validation," "packaging validation," or "engineering analysis." These are typically conducted according to recognized standards (e.g., ISO, ASTM) which dictate appropriate sample sizes for testing (e.g., for sterility, a certain number of units must pass tests; for aging, a specific number of packages are subjected to accelerated aging).
• Data Provenance: The data provenance is internal to OrthoPediatrics Corp., generated through their quality system and R&D processes as part of the 510(k) submission. It would be prospective for the specific tests conducted for this submission (e.g., packaging validation on new sterile packaging). The biocompatibility assessment references data from preceding predicate devices. The country of origin of the data is not specified beyond the company being based in Warsaw, Indiana, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. Ground truth for non-clinical performance (like sterility, shelf life, packaging integrity) is established through validated testing methodologies and engineering analyses, not by expert human interpretation of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required (e.g., clinical endpoint assessment, image reading). Here, acceptance is based on quantitative/qualitative results from engineering and validation tests meeting pre-defined specifications.

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 submission is for a physical, implantable medical device, not an AI/software-as-a-medical-device (SaMD).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this special 510(k) is the successful demonstration of:

• Sterility: Absence of viable microorganisms as per validated sterilization methods.
• Shelf Life: Maintenance of device integrity and function after accelerated and/or real-time aging.
• Packaging Integrity: Package seals and materials remain intact and protective after challenging conditions.
• Biocompatibility: Established safety profile from predicate devices and assessment of new packaging materials/processes.
• Mechanical Performance: Confirmation via engineering analysis that the changes do not degrade the device's original mechanical properties.

8. The sample size for the training set
Not applicable. This is not a machine learning/AI device.

9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.

Ask a specific question about this device

The Pediarity™ system is intended for use in the home setting and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-notion conditions.

The Pediarity™ system is not a monitoring device and does not provide physiological alarms during use.

Measurements are sent to a web server for remote review by a physician.

The Pediarity™ system is a non-invasive, innovative, and advanced solution that allows to measure wirelessly several physiological parameters (SpO2, Pulse Rate) of infants and children up to 12 years old in non-motion conditions.

The Pediarity™ system is composed of:

• a) Gabi™ Band, a non-invasive, wearable, wireless measuring device positioned around the patient's upper arm.
• b) Gabi™ Monitor, made of:
  • Gabi Monitor App: a mobile application dedicated to caregivers, allowing to o start and stop a recording of physiological parameters measured by the Gabi Band, displays measuring information and transfers collected data to the Gabi Cloud via Wi-Fi.
  • Gabi Monitor Tablet: a tablet provided to the caregiver inside the solution o package, on which the Gabi Monitor App is pre-installed.
• c) A Gabi™ Cloud, an online service that stores and manages the collected data and shares them with Gabi Analytics.
• d) Gabi™ Analytics, a web interface allowing the Healthcare Professionals (HCP) to access and review remotely the physiological parameters of the patient.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:

1. Table of acceptance criteria and reported device performance:

Note: The document explicitly states the SpO2 accuracy requirement of less than or equal to 3.5%. The pulse rate accuracy of 3 bpm is stated as "Same" as the predicate, implying it meets the same standard.

2. Sample size used for the test set and the data provenance:

• Sample Size (Clinical Study): 12 healthy adult male and female volunteers.
• Data Provenance: The clinical studies were conducted in the United States. They appear to be prospective, as hypoxia was induced to different and stable levels of oxyhemoglobin saturation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, for the SpO2 accuracy clinical study, ground truth was established by:

• Blood gas analysis using an ABL-90 multi-wavelength oximeter. This is a highly accurate method for determining oxyhemoglobin saturation and is considered the gold standard for ground truth in SpO2 accuracy studies. The operation and interpretation of this equipment would typically be performed by trained medical professionals (e.g., laboratory technicians, physicians) who are experts in blood gas analysis, but their specific number and qualifications are not provided.

4. Adjudication method for the test set:

Not applicable. The ground truth for SpO2 accuracy was established through direct measurement by a reference device (ABL-90 multi-wavelength oximeter) rather than expert consensus requiring 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 conducted. This type of study (MRMC for AI assistance) is not relevant to this device, which is a standalone oximeter measuring physiological parameters.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone clinical study was performed to demonstrate the SpO2 accuracy of the Pediarity™ system. The device itself performs the measurement and calculation of SpO2 and Pulse Rate.

7. The type of ground truth used:

For the SpO2 accuracy clinical study, the ground truth was blood gas analysis performed using an ABL-90 multi-wavelength oximeter.

8. The sample size for the training set:

The document does not specify the sample size for any training set. It describes a clinical study for performance validation (testing) and refers to software verification and validation, but not a specific training set size for an AI/ML algorithm (though it does mention "the signals obtained by the photodetector are then processed," which could imply an algorithm).

9. How the ground truth for the training set was established:

The document does not provide information on a training set or how its ground truth was established.

Ask a specific question about this device

The Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained frauma or disease. The patient population is pediatric, including child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients.

The Pediatric Nailing Platform | Tibia offers a selection of rigid intramedullary nails for internal stabilization of the tibia. When a tibia is broken into multiple pieces, via a traumatic fracture(s), disease, or planned osteotomy(ies), alignment and stabilization of the bone fragments is critical to ensuring successful healing. When inserted down the intramedullary canal and locked with screws both proximally and distally, a rigid metallic nail provides resistance to bending and axial loading of the bone. In cases where compression is desired to stimulate bone regeneration, a dynamization slot can be utilized. End caps may be implanted with the nail, to ease removal by protecting the proximal threads of the nail and prevent bony ingrowth, as well preventing incarceration of the nail. All implants are single use and are made of Ti-6A1-4V ELI. The system is implanted using Class II and Class I exempt instruments. All implants and instruments in the system are provided non-sterile.

This FDA 510(k) summary does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML-driven devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and standard performance testing.

Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth for an AI/ML device is not applicable or cannot be extracted from this document.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or reported device performance in the context of an AI/ML study. It refers to:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

None of the above information can be extracted from the provided document. The document describes a traditional medical device (intramedullary nail) rather than an AI/ML-driven device. The performance data mentioned refers to biocompatibility, MR safety, and mechanical testing against recognized standards (ASTM F1264 and ASTM F543) to demonstrate the physical properties and safety of the implant, not to the performance of an algorithm or its impact on human readers.

Ask a specific question about this device

Pediatric Nailing Platform | Femur is used for pediatric and small stature as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The OrthoPediatrics Pediatric Nailing Platform | Femur is for single use only.

Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails are provided as child nails and adolescent nails. The child nails are available in diameters of 7, 8 and 9 mm with a length of 200 to 420 mm depending on the diameter. The adolescent nails are available in diameters of 9, 10, 11, 12 mm with a length of 280 to 500 mm depending on the diameter. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. The screws are available in 3.8, 4.0, 4.5 and 5.0 mm in diameter and 15-120 mm in length depending on the diameter. The end caps are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The Pediatric Nailing Platform | Femur system is implanted using class I exempt instruments.

The subject implants under this submission in the Pediatric Nailing Platform | Femur are for single use only and will be provided non-sterile. The class II and class I exempt instruments can be single use or reusable and they are also provided non-sterile. All class II instruments have been cleared under K172583. The devices must be sterilized by the end user before use.

The provided text is a 510(k) summary for a medical device (Pediatric Nailing Platform | Femur) submitted to the FDA. It does not contain any information about acceptance criteria, device performance in a clinical study, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document describes a traditional 510(k) submission for an intramedullary fixation rod, which is a physical implant, not a software or AI/ML device. The "Performance Data" section refers to verification testing (e.g., Torsional Performance & Driving Torque, Axial Pullout, Bending Strength, Full Construct) conducted to demonstrate that new physical components (longer adolescent nails, longer screws, new end caps) meet design input requirements and are substantially equivalent to a previously cleared predicate device. It also mentions an evaluation for use in an MR Environment.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for AI/ML testing, expert ground truth establishment, or MRMC studies because this type of information is not relevant to the review of a physical implant device like the one described here.

To answer your prompt, I would need a document related to the FDA clearance of an AI/ML-based medical device.

Ask a specific question about this device

The Pediatric Nasogastric Feeding Tubes - Single ENFit Port are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Ports are intended for hydration, feeding and administration of oral medications for pediatric patients who require enteral feeding. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12.

The provided text is a 510(k) summary for the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of an AI-powered diagnostic device.

Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI diagnostic device is not present in the provided text. The document details performance testing for a physical medical device (nasogastric feeding tubes), not an AI algorithm.

Specifically:

• There is no AI device described.
• There are no acceptance criteria for AI performance (e.g., accuracy, sensitivity, specificity).
• There is no mention of a test set, training set, ground truth acquisition involving experts, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section (pages 9-10) describes non-clinical tests performed on the physical feeding tubes, such as biocompatibility, pressure leak testing, tensile testing, and connector performance tests against various ISO standards. It explicitly states, "Clinical tests were not required to demonstrate performance... Product functionality has been adequately assessed by non-clinical tests." and "Animal tests were not required... Product functionality has been adequately assessed by non-animal tests."

Ask a specific question about this device

The OrthoPediatrics Pediatric Nailing Platform|Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; prophylactionalling of impending pathologic fractures; nonunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The OrthoPediatrics Pediatric Nailing Platform|Femur is for single use only.

The proposed OrthoPediatrics Pediatric Nailing Platform|Femur seeks to add sterile packaged nails for distribution. All subject components have previously been cleared as non-sterile implants. All other components of the OrthoPediatrics Pediatric Nailing Platform|Femur will remain non-sterile to be sterilized by end-user.

The OrthoPediatrics Pediatric Nailing Platform|Femur nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design which with an advanced surgical technique. The smaller diameter of the nail allows it to be inserted in patients with a narrow medullary canal and allows for easier insertion without the need for excessive reaming.

The proposed nails are manufactured from stainless steel conforming to ASTM F138 and are available in child and adolescent configurations:

• The child nails are available in 7mm, 8mm, and 9mm diameters.
• The adolescent nails are available in 9mm, 10mm, 11mm, and 12mm diameters.
• These nails range in length from 20cm to 42cm, depending on the naildiameter.
• Surgeon preference dictates the appropriate nail size required to stabilize the fracture and allow for appropriate healing.

This document is a 510(k) premarket notification for a medical device called the "OrthoPediatrics Pediatric Nailing Platform|Femur". It is a submission to the FDA (Food and Drug Administration) for clearance to market the device.

The document discusses the device's indications for use, its technical characteristics, and compares it to a legally marketed predicate device (K172583 OrthoPediatrics' PediNail Intramedullary Nailing System).

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device or diagnostic.

The core of this submission is about demonstrating "substantial equivalence" to a predicate device, specifically regarding the addition of sterile packaged nails. It focuses on mechanical properties of the material after sterilization, not on software performance, diagnostic accuracy, or human-AI interaction.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) from the provided text because it describes a hardware medical device clearance, not an AI/algorithm-based diagnostic or treatment planning system that would typically have the kinds of performance studies you are asking about.

Ask a specific question about this device

The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction.

The Pediatric Device for Induction of Anesthesia (PeDIA) is a single-use, disposable, mask-free anesthetic delivery system and method used for children 3 years and older. The balloon is a standard, legally marketed reservoir bag that is modified by the addition of a whistle at the opposite end of the connector (which is a closed end on standard balloons). This balloon is used in place of the initial application of anesthesia gasses. Once the child is sedated the product is removed and replaced with a standard pediatric mask for the duration of anesthesia.

When analyzing the provided text for acceptance criteria and a study proving device performance, it's important to note that this FDA 510(k) clearance document is for a Class I medical device (a reservoir bag with a modification), not typically a device that requires extensive clinical studies with human participants to demonstrate performance or to assess diagnostic accuracy in the way that, for example, an AI-powered diagnostic imaging device would.

The "performance data" discussed here focuses on engineering, biocompatibility, and regulatory compliance rather than diagnostic performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, and training data will not be present in this document, as they are not applicable to the type of device and regulatory pathway involved.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct table of acceptance criteria with corresponding performance numbers in the way one might expect for a diagnostic AI device. Instead, it describes general compliance and testing outcomes.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in terms of clinical study sample size. The tests appear to be laboratory and bench testing on the device prototypes/samples. No patient "test set" in the diagnostic sense is mentioned.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" refers to engineering test results and biocompatibility assays.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device does not generate diagnostic outputs requiring expert interpretation for ground truth. The "ground truth" here is compliance with engineering standards and safety/biocompatibility profiles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There are no diagnostic interpretations to adjudicate.

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. This is not an AI/diagnostic device, and no MRMC study was performed or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. Not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is adherence to established international standards (ISO 5362, ISO 5356-1) and FDA guidance for biocompatibility (ISO 10993-1), along with internal design specifications. There is no clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable.

Ask a specific question about this device

The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements.

PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients.

The pressure injectable EOCVC Oligon catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media, and central venous pressure monitoring.

The suture loop and box clamp are intended to be used to facilitate the suturing the catheter at the site of insertion.

The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of perculancous entry of the catheter.

The Edwards Oximetry Central Venous Catheter is a non-balloon catheter that provides the means for infusion of solutions, measuring pressure, and taking blood samples through the distal lumen (terminates at the catheter tip), the proximal lumen (terminates 7 cm proximal to the tip), and the medial lumen (terminates 5 cm proximal to the tip). Edwards Oximetry Central Venous Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The PediaSat oximetry catheters are non-balloon catheters that provide the means for infusion of solutions, measuring pressure, and taking blood samples. These catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The EOCVC Oligon catheter is a non-balloon catheter that provides the means for infusion of solutions measuring pressure injecting contrast media, and taking blood samples through the distal lumen (terminates 7 cm proximate to the tip), and the medial lumen (terminates 5 cm proximal to the tip). The EOCVC Oligon catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences monitor and compatible bedside module. All catheters are manufactured with a polyurethane-based Oligon polymer (containing silver, platinum, and carbon black) which has antimicrobial properties.

Oxygen saturation is monitored by fiberoptic reflectance spectrophotometry. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood.

The PediaSat Oximetry Catheter is a 3 lumen catheter available with a diameter of 4.5 French (F) and 8 cm in length. The EOCVC Oximetry Catheters are 3 lumen catheters available with a diameter of 8.5F and in lengths of 16 and 20 cm. EOCVC and PediaSat catheters are manufactured from polyurethane.

A suture loop and a specially molded box clamp are provided with each EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter to facilitate suturing of the catheter at the site of insertion. The suture loop and box clamp can be placed anywhere along the catheter body at the discretion of the clinician.

The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.

The EOCVC (Oligon and non-Oligon) and PediaSat Kits consist of accessories previously cleared for marketing as well as accessories that are the subject of this submission.

This submission is for clearance of proposed modifications to the accessories (suture loop, box clamp and dilator) for use with the previously cleared EOCVC Oligon (K160645), PreSep (now EOCVC), and PediaSat (K053609) Oximetry Catheter Kits. Additional accessories are listed on table below.

The provided text is a 510(k) summary for the Edwards Oximetry Central Venous Catheter (EOCVC), Edwards Oligon Oximetry Central Venous Catheter, and PediaSat Oximetry Catheters. The submission aims for clearance of proposed modifications to accessories (suture loop, box clamp, and dilator) for use with previously cleared catheters. The study described focuses on demonstrating the substantial equivalence of these modified accessories to predicate device accessories.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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 sample sizes used for the functional and performance testing of the accessories. It only mentions that "Testing was conducted." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These studies are typically conducted in a laboratory setting by the manufacturer.

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 document. The testing described appears to be primarily bench testing and performance verification against engineering specifications, rather than clinical studies requiring expert ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective evaluations (e.g., image interpretation). The tests described are objective engineering and performance verification tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device on human reader performance, usually in diagnostic imaging. The submission focuses on the substantial equivalence of modified catheter accessories through bench and performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical catheter and its accessories, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests would primarily be engineering specifications and established performance benchmarks derived from the predicate devices and industry standards. For example, "tensile strength" would be compared against a defined maximum or minimum force, and "dimensional verifications" against specified measurements.

8. The Sample Size for the Training Set

Not applicable. The described study is not a machine learning study requiring a training set. It involves physical product testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device