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The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow, or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric and small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The PediFlex™ Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, clamp screws and end caps for the application of aiding bone fracture repair and healing. All the implants are MR conditional. The system is implanted using Class II and Class I exempt surgical instruments.

The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium alloy (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm.

The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. The use of the interlocking clamps is optional. The interlocking clamps are manufactured from both 316L stainless steel and titanium alloy (Ti-6Al-4V) materials. The 316L stainless steel interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm, 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The titanium alloy (Ti-6Al-4V) interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al- 4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.

The PediFlex™ end caps are designed to affix to the exposed nail tip to help prevent soft tissue irritation. The use of the end cap is optional. They are not a structural element and impart no additional strength to the construct. The subject end caps are manufactured in titanium alloy (Ti-6Al-4V) and are available in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments. The material of the end cap must match the material of the nail used in the surgery.

The flexible nails, interlocking clamps, clamp screws and end caps in PediFlex™ Flexible Nail System are offered both sterile and non-sterile. All other Class II implants and instruments of the PediFlex™ Flexible Nail System are offered non-sterile to be sterilized by the end-user.

The provided FDA 510(k) clearance letter for the PediFlex™ Flexible Nail System primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a study proving that the device meets specific acceptance criteria in a clinical performance sense (like an AI/ML device would).

The information in the document highlights design verification and validation activities related to safety and functionality for a medical implant, but it does not outline acceptance criteria for a diagnostic or AI-driven system that would involve performance metrics like sensitivity, specificity, or human-in-the-loop improvements.

Therefore, for aspects related to "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes for test and training sets," "expert ground truth establishment," "adjudication," "MRMC studies," "standalone performance," and "ground truth types," the provided document does not contain the necessary information to answer those questions in the context of an AI/ML device or a comparative clinical study.

The document states:

• "The subject PediFlex™ Flexible Nail System and predicate device share identical intended use, patient population, principles of operation, and all fundamental technological characteristics."
• "There are some differences... However, those differences are supported by successful testing provided in this submission. Therefore, such differences do not raise new questions of safety and effectiveness."
• "Results of the performance testing demonstrate substantially equivalent performance of the subject device as compared to the predicate."

This indicates that the "acceptance criteria" were likely related to demonstrating that the changes (sterilization, packaging, shelf life, MR conditional labeling) did not negatively impact the established safety and effectiveness of the device, rather than establishing new performance benchmarks.

However, I can extract the information relevant to the types of studies and testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a 510(k) for a physical medical device (Flexible Nail System) demonstrating substantial equivalence to a predicate, the "acceptance criteria" are not reported as specific clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) like they would be for an AI/ML diagnostic. Instead, the performance data focuses on demonstrating that the manufacturing/design changes (sterilization, packaging, shelf life, MR compatibility) do not raise new questions of safety or effectiveness and that the device maintains its intended physical properties and functionality.

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

• Test Set Sample Size: Not applicable in the context of clinical performance data for an AI/ML algorithm. The studies mentioned are primarily bench testing and engineering analyses for device characteristics. Specific sample sizes for each standard (e.g., number of packages tested for sterility, number of nails tested for MR compatibility) are not detailed in this summary.
• Data Provenance: Not applicable for clinical data. The testing is laboratory and engineering-based (e.g., material testing, packaging integrity testing).

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

• Not applicable. Ground truth in this context refers to defined engineering and material properties, not expert clinical interpretations via a consensus process.

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

• Not applicable. This is not a clinical study involving human readers or interpretations needing 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:

• No. This is a submission for a physical medical implant, not an AI/ML diagnostic or assistive device.

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

• No. This is for a physical medical implant.

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

• For the physical device, the "ground truth" for the performance data is based on established engineering standards, material specifications, and regulatory guidelines. For example:
  • Sterility: Absence of microbial growth (based on AAMI/ISO standards).
  • Packaging integrity: No breaches or failures (based on ASTM/ISO standards).
  • Material properties: Adherence to specified mechanical properties for the material (implied by type of material, though specific data is not shown).
  • MR Conditional status: Demonstrating acceptable heating, artifact, and force under specific MR conditions defined by ASTM standards.

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.

In summary, the provided document details the verification and validation activities for a physical medical implant (PediFlex™ Flexible Nail System) to demonstrate its safety and effectiveness under a 510(k) pathway, primarily for design and manufacturing changes. It does not provide the kind of performance data (e.g., clinical accuracy, reader studies) that would be presented for an AI/ML-driven device.

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The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures and lower extremity fractures in pediatric or small stature patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The PediFlex™Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, and clamp screws for the application of aiding bone fracture repair and healing. The PediFlex™Flex™Flexible Nail System was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class I exempt instruments.

The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6A1-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium allov (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm. The tip of the flexible nails is available in two designs, the round tip and the advanced round tip. Both tip designs are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V) in various diameters and lengths. The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. Using the interlocking Clamps is optional in the surgery. The interlocking clamps are manufactured from both 316L stainless steel and titanium allov (Ti-6Al-4V) materials. The 316L stainless steel interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm. 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, and 35 mm in length. The titanium alloy (Ti-6A1-4V) interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6AI-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al-4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.

The system is implanted using Class I exempt instruments. The Class II instruments in the system include hex drivers which are for installing the clamp screws and the hex easy out which is to remove the clamp screws if the hex strips. The instruments in the system are Class I exempt.

The implants in the PediFlex™ Flexible Nail System are for single use only and will be provided non-sterile. The instruments in the PediFlex™ Flexible Nail System are reusable, except for the Hex Easy Out instrument which is single use. Instruments are also provided non-sterile. The devices must be sterilized by the end user before use.

The prompt provides a 510(k) summary for the PediFlex Flexible Nail System. However, this is a medical device for orthopedic fixation and does not involve AI or algorithms that would have a "test set," "training set," "ground truth," or "human readers." The document focuses on performance data related to mechanical testing, MR compatibility, and biocompatibility, as per regulatory standards for such devices.

Therefore, I cannot provide the requested information because the context of the device and the provided document do not align with the questions about AI performance, sample sizes for AI training/testing, or expert-established ground truth for AI algorithms.

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The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

Line extension includes 1.5 and 4.5 mm diameters in 300mm and 450 mm lengths, respectively, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed. Note: the two diameters shown in bold are line extensions to our (Titanium) PediFlex system cleared though K081097, which is currently available in 2.0, 2.5, 3.0, 3.5, and 4.0mm diameters. The device is the same as flexible pins and ender nails that have been used to fix fractures in long bones for years in an intramedullary fashion. When these types of nails are used, they will be used in opposing pairs. The nail will be bent to provide three-point fixation. The ideal fixation points will be at the insertion site, the fracture site, and some point beyond the fracture site. Materials: The devices are manufactured from Ti-6Al-4V which meets the ASTM-F136 standard, and 316L stainless steel which meets the ASTM-F138 standard. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

The provided text describes a medical device, the OrthoPediatrics PediFlex™ Flexible Nail System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) premarket notification approval letter from the FDA. In 510(k) submissions, manufacturers demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing similar design, materials, and intended use, and may include performance testing to ensure the new device performs as safely and effectively as the predicate. However, detailed acceptance criteria and a specific study report proving the device meets those criteria are not present in the provided text.

Based on the information provided, here's what can be extracted:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not mentioned. This type of information is typically associated with studies involving expert review of data, which is not described here.

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

• Not mentioned.

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 MRMC comparative effectiveness study is mentioned. This device is a physical 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 a physical medical device (intramedullary nail), not an algorithm or software.

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

• Not applicable in the context of this document. For physical devices demonstrating substantial equivalence, "ground truth" often relates to adherence to material standards, functional testing, and clinical outcomes of predicate devices, which are not detailed here. The submission relies on established safety and effectiveness of similar devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

Summary of what the document does provide:

• Device Name: OrthoPediatrics PediFlex™ Flexible Nail System
• Manufacturer: OrthoPediatrics, Corp.
• Device Type: Intramedullary Elastic Nail (line extension including 1.5mm and 4.5mm diameters in 300mm and 450mm lengths).
• Materials: Ti-6Al-4V (ASTM-F136) and 316L stainless steel (ASTM-F138).
• Function: Provides immediate stability and temporary fixation for long bone fractures.
• Indications for Use: Fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility is required, including upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients (designed not to disturb growth plates in pediatric patients).
• Basis for Substantial Equivalence: Similarities in design, materials, and indications to several predicate devices (listed in the text).
• FDA Approval: Cleared with 510(k) Number K082375 on October 17, 2008.

The document essentially states that the new PediFlex line extension is substantially equivalent to existing, legally marketed devices, implying that its performance is acceptable based on the history and regulatory clearance of those predicates. It does not elaborate on new performance studies with specific acceptance criteria beyond material and general functional descriptions.

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The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed.
Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

The provided text does not contain information regarding acceptance criteria or the study that proves the device meets specific acceptance criteria in the context of a performance study like an AI/ML device.

This document describes a 510(k) premarket notification for a medical device called the OrthoPediatrics PediFlex™ Flexible Nail System, which is an intramedullary elastic nail. The focus of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria for a new clinical efficacy or diagnostic accuracy claim.

The "Basis for Substantial Equivalence" section explicitly states: "OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications."

Therefore, I cannot provide the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert qualifications, or details about MRMC studies or standalone algorithm performance. These types of studies are typically associated with devices that have a new clinical function or AI/ML components requiring validation against specific performance metrics, which is not the case for this 510(k) submission.

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