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The RONAVIS-FX is intended to be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system and for temporary bone stabilization (

The RONAVIS-FX is an external fixation device configured as a pin, which is inserted into the bone unicortically during orthopedic procedures. It consists of three components: a sleeve, an inner pin, and an anchor head. It is made of SUS316L and is provided non-sterilized. It should be sterilized by the user before use and is prohibited from being reused.

The provided document is an FDA 510(k) clearance letter for a medical device called RONAVIS-FX. This letter does not contain any information regarding clinical studies, acceptance criteria for an AI/algorithm, or the performance of such an AI/algorithm. It pertains to a physical medical device (an anchor pin) for bone fixation, not a digital health product or an AI-based diagnostic tool.

Therefore, I cannot fulfill the request for information regarding a study that proves the device meets acceptance criteria for an AI/algorithm, as the provided input does not describe such a device or study.

The document discusses:

• Device Type: Smooth or Threaded Metallic Bone Fixation Fastener (an anchor pin).
• Indications for Use: Applied to the skeletal system for pulling force (traction) and temporary bone stabilization (

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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 Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Impact PEEK Union Nail System." This letter details the administrative aspects of the clearance, including the device name, manufacturer, regulatory classification, and the FDA's determination of substantial equivalence to predicate devices.

However, it does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for software-based or AI/ML-driven medical devices.

The document specifically states:

• "No FDA performance standards have been established for the Impact PEEK Union Nail System."
• The non-clinical testing performed includes "Static and Dynamic Bending, Axial Pullout (ASTM F1264-16, ASTM F543-17)" and "Shear Testing (ASTM D2344)." These are mechanical and material property tests common for orthopedic implants, not studies designed to assess the performance of a software algorithm or AI model in an clinical setting.
• The "Equivalence to Predicate Devices" section emphasizes "similar design and similar dimensions," manufacturing material (HA Enhanced PEEK), "same intended use," and "similar technological characteristics," all referring to the physical implant rather than computational performance.

Therefore, I cannot extract the requested information from this document because it pertains to a physical orthopedic implant, not an AI/ML or software-driven medical device. The questions you've asked (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance) are highly relevant to the validation of AI/ML medical devices but are not applicable to the type of device described in this 510(k) clearance letter.

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Kirschner Wires are used for;
· As guide pins for insertion of other implants
· Bone reconstructions
· Fixation of bone fractures and osteotomies
· Implanted through the skin for traction applied to the skeletal system

Biomet Inc manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Biomet Kirschner Wires (K-wires) are rigid yet malleable wires with penetrating tips such that they may be inserted through tissue and into bone to alow for traction of bone fragments as desired or for alignment quides for other bone fixation implants. These wires are available in multiple diameters, same length and unthreaded (smooth) versions.
Biomet Kirschner Wires are single use and provided in both sterile configurations. Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.

The provided text describes a 510(k) premarket notification for Biomet Kirschner Wires (K-Wires). It states that the device is substantially equivalent to a predicate device based on its indications for use, technological characteristics, and conformance to specific standards.

However, the document does not contain the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data provenance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as these aspects are typically relevant for AI/ML-driven medical devices or diagnostic tools. The Biomet Kirschner Wires are described as "rigid yet malleable wires with penetrating tips," implying they are a physical medical device, not a software-based or AI-enabled device.

Therefore, many of the requested categories are not applicable to the information provided in the given text.

Here's a breakdown of the available information based on your request:

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 for Test Set: Not specified. Testing for conformance to ASTM standards typically involves a defined sample size as per the specific standard, but this detail is not present in the document.
• Data Provenance: Not applicable in the context of device conformance to ASTM physical/mechanical standards.

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

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Conformance to ASTM standards is typically evaluated by technical testing against predefined specifications.

4. Adjudication method for the test set

• Not applicable. Conformance to ASTM standards involves objective measurement and comparison against specified limits, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• Not applicable. This is a physical bone fixation device, not a diagnostic imaging or AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Ground Truth Type: Conformance to established industry standards (ASTM F138-19 for mechanical properties and ASTM F366-17 for dimensional properties). These standards themselves define the "ground truth" or acceptable parameters for such devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and materials science.

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

• Not applicable. Since there is no training set for an algorithm, the method for establishing its ground truth is irrelevant. The "ground truth" for the device's characteristics is inherently defined by the ASTM standards it aims to meet.

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The OSSIO® Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, ostectomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® devices are made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alphahydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The provided text is a 510(k) summary for the OSSIO® Pin Product Family, OSSIOfiber® Compression Screw, and OSSIOfiber® Trimmable Fixation Nail. This document primarily focuses on demonstrating substantial equivalence to predicate devices for expanding the indications for use to include children and adolescents.

Therefore, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the format typically associated with AI/ML-based device performance evaluations. The information provided is for a traditional medical device (fixation pins, screws, and nails) where the performance is assessed through non-clinical data (toxicological risk assessment, chemical characterization, and mechanical performance testing) comparing it to predicate devices.

Based on the provided text, I cannot complete the requested table or answer the questions related to AI/ML device performance studies because the document pertains to a traditional medical device and not an AI/ML diagnostic or therapeutic device.

Here's an analysis of why the requested information is absent:

• No AI/ML Component: The devices described are physical implants (pins, screws, nails) made of degradable materials. There is no mention of any software, AI, or machine learning component.
• Performance Evaluation Method: The substantial equivalence argument is based on:
  • Identical/Similar Intended Use: Expanding the age range for existing indications.
  • Material Composition: Degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers.
  • Design Characteristics: Similar to predicate devices.
  • Manufacturing and Sterilization Methods.
  • Principles of Operation.
  • Non-Clinical Data: Toxicological risk assessment, chemical characterization, and mechanical performance testing (where new worst-case scenarios were not identified).
• Lack of Study Design for AI/ML: There are no details about test sets, data provenance, ground truth establishment by experts, adjudication methods, or MRMC studies because these are not relevant to the type of device being cleared.

In summary, the provided document describes a traditional medical device clearance, not an AI/ML-enabled device. Therefore, the information required to fill out the table and answer the questions regarding acceptance criteria and performance study details for an AI/ML device is not present.

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The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.

The provided text is a 510(k) summary for the Hammerdesis™ Interphalangeal Fusion System, a medical device. This document focuses on demonstrating the substantial equivalence of the device to existing predicate devices, primarily through mechanical performance testing.

It does not contain information about an AI/ML-driven device or diagnostic study. Therefore, I cannot provide a response addressing acceptance criteria and study details related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document describes the device, its indications for use, technological characteristics, and performance data related to its mechanical properties. The performance data section states:

"The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459)."

This indicates that the acceptance criteria for this device are based on its mechanical equivalence or superiority to the specified predicate device in these specific tests, rather than diagnostic accuracy metrics.

To answer your request, the provided document would need to be about a diagnostic AI/ML device, which it is not.

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OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instrumentations.

This document does not describe acceptance criteria or a study proving that the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for a medical device called the OSSIOfiber® Cannulated Trimmable Fixation Nail.

The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K203465), rather than proving performance against specific acceptance criteria through new clinical or non-clinical studies.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document explicitly states: "Non-clinical performance testing was not performed as the subject device does not represent a new mechanical performance worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail cleared family." This means the submission did not include new studies to generate performance data for this particular longer nail length against new acceptance criteria.
• Focus on Substantial Equivalence: The entire submission hinges on the claim that the new device (a longer version of an existing nail) has "the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K203465)." Because of this, new performance studies were deemed unnecessary by the manufacturer and accepted by the FDA for this specific 510(k) submission.
• No AI Component: The device described is a physical medical implant (a bone fixation nail), not an AI/ML-driven diagnostic or therapeutic device. Therefore, concepts like acceptance criteria for AI performance, training/test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not relevant to this submission.

In summary, the provided text does not contain the information required to answer your prompt because the 510(k) submission for this device did not involve new performance studies with acceptance criteria, as it was based on demonstrating substantial equivalence to a predicate device.

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Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:

• Osteotomies or arthrodesis of fractures management in the foot or hand
• Fixation of small bone fragments, in long bones or small bones fractures

The Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:

• Osteotomies or arthrodesis of fractures management in the foot or hand
• Fixation of small bone fragments, in long bones or small bones fractures- Fixation of small bone fragments, in long bones or small bones fractures

Steri-Caps are comprised of a pin ball intended to be placed on the end of a wire or pin protruding from bone, secured with a setscrew, and used to protect the user and wire.

The pin balls are offered in diameters of 8.95mm and 12.13mm, and designed to accommodate K-wires or pins less than 1.65mm in diameter. The set screws are offered in lengths of 3.30mm. The longer of the set screws is referred to as the Long Set Screw. Each set screw is threaded with an M4 x 0.7 outer thread, and has a 2.50mm diameter hexagonal cannulation for use with the 2.5mm driver. The 2.5mm driver is used to set the set screw once the pin or wire has been placed through the pin ball. Each pin ball and set screw is offerent materials, namely 6A4V ELI Titanium per ASTM F136, 304 SST, or 17-4 SST, Heat Treat to condition H900. The component is then treated with an ES (Electro-Spec) Surface Treatment, intended to add hardness, scratch resistance, hydrophobicity, and wear resistance. The ES Surface Treatment is a 4-to-15-micron thick, electroplated alloy that can be plated on numerous types of surfaces providing better scratch-resistance, corrosion, and tarnish properties than conventional surfaces can provide due to its hardness and hydrophobic properties. A satin finish is provided on all components.

All components and the instrument are offered non-sterilization before use

The provided text is a 510(k) summary for a medical device called "Electro-Spec Steri-Caps." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The document explicitly states:

• "No non-clinical testing was performed."
• "No clinical testing was performed."

This implicitly means there was no study conducted in the typical sense to establish performance against acceptance criteria for this specific 510(k) submission. The device is being cleared based on substantial equivalence to existing devices, relying on the safety and effectiveness established for the predicate devices.

However, I can extract the available information and highlight what is missing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The above "Acceptance Criteria" are implied by the device's function and comparison to predicate devices, and the "Reported Device Performance" is derived from the device description and material claims. There are no specific numerical acceptance criteria or test results presented in this summary, as no non-clinical or clinical testing was performed for this 510(k) submission. The FDA cleared it based on substantial equivalence.

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

• Sample Size: Not applicable, as no dedicated test set or study was performed for this 510(k) submission.
• Data Provenance: Not applicable.

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

• Not applicable, as no dedicated test set or study requiring expert ground truth establishment was performed.

4. Adjudication method for the test set

• Not applicable.

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 device is a mechanical component, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable.

8. The sample size for the training set

• Not applicable, as no algorithm or AI was developed or studied.

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

• Not applicable.

Summary of what the document does provide regarding device evaluation:

The 510(k) submission for Electro-Spec Steri-Caps relies on substantial equivalence to legally marketed predicate devices (K203698 and K192768).

The comparison focuses on:

• Indications for Use: Stated to be the same as the primary predicate device (K203698).
• Technological Characteristics: The subject device has the same intended use and characteristics such as inserting a pin/K-wire through the device with a locking mechanism. Any differences (shape, materials) are stated not to "result in new questions of safety or effectiveness." Specifically, the materials of the subject device are asserted to meet the requirements of ISO 10993-1.

The crucial information about formal acceptance criteria and the study proving adherence to them is absent because the regulatory pathway chosen (510(k) substantial equivalence) for this type of device (a metallic bone fixation fastener component) typically does not require new non-clinical or clinical studies if substantial equivalence to a predicate can be demonstrated through design, material, and intended use comparisons.

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The Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for inplants or implantation through the skin so that traction may be applied to the skeletal system.

The Tyber Medical Pin and Wire System is designed for hand, foot, and small bone fragment repairs or fusions. Uses include fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. It is manufactured from stainless steel, and Titanium Alloy. They are available in a variety of lengths, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile, single use. Non-sterile devices are intended to be sterilized at the point of use. The pins and wires are made from stainless steel (316L per ASTM F-138) and titanium alloy (Ti-Al-4V ELI per ASTM F136).

This FDA 510(k) summary provides limited information regarding formal acceptance criteria or a detailed study proving the device meets specific performance criteria. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a standalone performance study with predefined acceptance criteria.

However, based on the provided text, here's an analysis of what can be inferred and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantitative performance metrics are listed in the document. The submission is based on substantial equivalence, implying that the device's performance is considered acceptable if it is comparable to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. No "test set" in the context of an AI/algorithm performance study is mentioned as no clinical or performance study was conducted.
• Data Provenance: Not applicable. No data or test sets were used for a performance study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No ground truth establishment by experts is mentioned as no performance study was conducted requiring such a process.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned as no performance study was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was preformed."

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The document explicitly states: "No clinical testing was preformed." The device described is a physical medical device (Pin and Wire System), not an algorithm or AI.

7. Type of Ground Truth Used:

Not applicable. As no performance study was conducted, no ground truth was established for the purpose of validating the device's performance in a study setting. The "ground truth" in this context is the performance and safety profile of the predicate devices against which the new device is compared for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set and corresponding ground truth.

Summary of the Study (or lack thereof) to Prove Acceptance Criteria:

The provided document describes a 510(k) Premarket Notification for the Tyber Medical Pin and Wire System. The "study" proving the device meets "acceptance criteria" is based on the principle of Substantial Equivalence (SE) to legally marketed predicate devices (K083490 - BioPro K-Wire and K100736 - SMT Schilling Metalltechnik GmbH).

The core of the submission's argument is:

• Indications for Use: The new device has similar indications for use as the predicate devices.
• Technological Characteristics: The new device shares similar design, material (stainless steel, titanium alloy), chemical composition, and principle of operation with the predicate devices.
• Manufacturing and Sterilization: The new device is manufactured and intended to be sterilized using the same materials and processes as the predicate devices (though the devices are provided non-sterile for point-of-use sterilization).

Based on these similarities, the FDA has determined that the Tyber Medical Pin and Wire System is substantially equivalent to the predicate devices. This determination implies that the new device is considered "safe and effective" without the need for new clinical or non-clinical performance studies, as no new or different questions regarding safety and effectiveness were raised compared to the predicate devices.

Key takeaway: This document is not about a performance study of an AI/algorithm. It's a regulatory submission for a physical medical device, demonstrating substantial equivalence to pre-existing, legally marketed devices. Therefore, many of the requested categories (like sample sizes, expert qualifications, and ground truth for AI performance) are not applicable to this type of submission.

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The HTS is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the HTS can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

This document is a 510(k) summary for the Hammertoe Truss System (HTS). It indicates that the purpose of the submission is to update the HTS implant offering to include two smaller sizes. The document outlines the device description, indications for use, and a comparison to predicate devices, focusing on the mechanical properties and MRI compatibility.

Here's an analysis based on your request, keeping in mind that the document mainly focuses on mechanical performance and equivalence to a predicate device, rather than a clinical study with patients or human readers.

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

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

This submission describes engineering performance testing and simulation analysis, not a clinical study on a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" in a clinical context are not applicable. The testing was done on physical device prototypes or through computer-simulated models.

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)

This is not applicable as the submission reports on mechanical and MRI compatibility testing of a physical device, not a diagnostic or AI-driven system requiring expert review of medical images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in clinical trials or diagnostic accuracy studies.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the safety and effectiveness of a physical implantable device based on mechanical and MRI compatibility testing, demonstrating substantial equivalence to a predicate device. It does not involve AI or human readers.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (implant).

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

The "ground truth" for this type of submission is based on engineering standards and established test methods (e.g., ASTM standards) for evaluating the mechanical properties and MRI compatibility of medical implants. The "truth" is whether the device physically performs in accordance with these validated standards and demonstrates similar characteristics to the predicate device.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set. The "training" for such devices involves design, manufacturing, and extensive bench testing.

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

This is not applicable for the reasons mentioned in point 8.

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