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SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.

SteriTrak™ is a sterile, temporarily implantable Kirschner wire (K-wire). SteriTrak™ is intended to be implanted into the bone for the purposes of providing an anchor for skeletal traction. SteriTrak™ is intended to be inserted while the patient is in the Emergency Room, prior to admittance to the Operating Room for surgery. When the patient is transferred to the Operating Room for surgery, skeletal traction is released and SteriTrak™ is removed.

The SteriTrak™ surgical grade 316L stainless steel pin is implantable up to 30 days. SteriTrak™ is provided with a guiding handle intended to be used as a pin stabilizing holder for the orthopedic surgeon.

The provided text is a 510(k) summary for the SteriTrakTM device, a skeletal traction pin. It focuses on establishing substantial equivalence to predicate devices based on intended use, design, technological characteristics, and non-clinical performance testing. However, it does not contain information about acceptance criteria or a study that utilizes AI/ML for medical image analysis, which is the premise of your request.

Specifically, the document does not provide the following information from your prompt:

• A table of acceptance criteria and reported device performance (in the context of AI/ML).
• Sample size used for the test set or data provenance for an AI/ML study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with AI assistance.
• Details about standalone (algorithm only) performance.
• The type of ground truth used (expert consensus, pathology, outcomes data) for an AI/ML model.
• Sample size for the training set of an AI/ML model.
• How the ground truth for the training set was established for an AI/ML model.

The document describes non-clinical performance testing such as:

• Biocompatibility assessment to ISO 10993-1
• Usability testing to IEC 62366-1
• Pin torque transfer to ASTM F-138-19 and ISO 5832-1
• Label legibility testing to ISO 14630:2012

These tests are standard for a medical device cleared via the 510(k) pathway, demonstrating mechanical, biological, and user interface safety and efficacy, but they are not related to AI/ML performance evaluation.

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The Arthrex DynaNite® PIP (Hammertoe) Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Arthrex DynaNite PIP (Hammertoe) Implant is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant has a threaded end and a barbed end. The implant will be offered in 12mm, 14mm and 16 mm lengths, each available in straight and bent configurations. The implant is provided on a handled inserter and is sold as sterile, single-use.

This document is a 510(k) premarket notification for the Arthrex DynaNite® PIP (Hammertoe) Implant. It is a Class II medical device for bone fixation. Here's a breakdown of the requested information:

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 each specific test (Barb Pull-out, Thread Pull-out, etc.). It only mentions that "testing was conducted to demonstrate that the Arthrex DynaNite PIP (Hammertoe) Implant performed statistically equivalent to the predicate device cleared under K960385."

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be data generated in support of this 510(k) submission, likely from laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The device performance tests described (mechanical and biological) are laboratory-based, objective measurements, not subjective evaluations requiring expert interpretation of a "ground truth" like in a diagnostic AI study.

4. Adjudication Method for the Test Set

This information is not applicable. As explained above, the tests are objective laboratory measurements, not assessments that require adjudication.

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

No. This document describes the performance of a physical medical implant through mechanical and biological testing. It is not an AI/software device that would typically undergo an MRMC comparative effectiveness study to assess human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This document concerns a physical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance tests are the objective measurements obtained from laboratory testing, which are then compared to the performance of the predicate device (K960385). For the Bacterial Endotoxins Test, the "ground truth" is adherence to established biological safety standards and regulations (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14).

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is a physical medical device and not an AI or machine learning model.

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

This information is not applicable, as there is no training set for a physical implant.

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The dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The dynaMX™ Intramedullary Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges. The implant is fully cannulated with threads on the distal side and two barbs on the proximal side. The implant is offered in multiple combinations of diameter and length to accommodate various anatomies. The dynaMX™ Intramedullary Implant is made of biocompatible Nitinol. The barbs of the implant are designed to exhibit superelastic properties at room and body temperature. As manufactured, one end of the implant has a screw thread, and the other end a pair of barbs. The screw thread is inserted into a drilled hole in the middle phalange. The barbed end is implanted into a broached canal in the proximal phalange. While inserting the barbed end of the implant, the barbs deflect inward to allow the implant to pass through the broached canal. Once inside the canal, the barbs superelastically return to their flared outward configuration to securely hold the implant in the bone. The dynaMX™ Intramedullary Implant is sold as part of a single use disposable kit. The kit includes an implant, pre-loaded onto a delivery device, a drill bit, a broach and a quide wire.

The provided document is a 510(k) premarket notification for a medical device called the "dynaMX™ Intramedullary Implant." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not contain detailed acceptance criteria and study results in the same way a clinical trial report would.

However, based on the information provided, I can infer what constitutes the "acceptance criteria" through the bench and cadaver testing listed and how the device aims to meet these through comparison with predicate devices.

Here's an analysis based on your request, structured as much as possible with the available information:

Key Takeaway: The document outlines a substantial equivalence claim based on laboratory studies (bench and cadaver tests) rather than human clinical trials involving complex statistical criteria for AI performance. Therefore, many of your specific questions related to AI-specific metrics, human reader studies, and large-scale data provenance are not applicable to this type of device and submission.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the dynaMX™ Intramedullary Implant are demonstrated through a series of laboratory studies (bench tests and cadaver tests) designed to verify the suitability of the device for its intended use, establish substantial equivalence with predicate devices, and confirm reproducibility of packaging. The successful completion of these tests, showing comparable performance to predicate devices, serves as the primary evidence for meeting acceptance criteria for this Class II medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for the bench and cadaver tests. It generally states a "series of laboratory studies." For cadaver tests, typically a limited number of cadaveric specimens would be used.

The data provenance is laboratory-based (bench tests) and cadaveric. There is no information regarding country of origin, but it is assumed the tests were conducted within the facilities of Arthrex, Inc. (or MX Orthopedics, Corp.) or their designated testing laboratories. These are effectively retrospective in the sense that they are conducted on inert materials or cadaveric tissue in a controlled lab setting, not in live patients.

3. Number of Experts Used to Establish the Ground Truth For The Test Set and Qualifications of Those Experts

This information is not applicable as the device is an implantable mechanical device, not an AI or diagnostic device that relies on expert ground truth for interpretation of output. The "ground truth" for this device's performance would be the physical properties and mechanical behavior observed in the specified laboratory tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication typically refers to expert consensus in interpreting diagnostic results or clinical outcomes. The performance of this device is assessed directly through engineering measurements and established material science principles in laboratory settings.

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

This information is not applicable. This device is a surgical implant, not a diagnostic or AI-powered system, and therefore, human reader studies with AI assistance are irrelevant to its evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical implant; there is no algorithm involved in its direct function for standalone performance evaluation in this context.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily engineering specifications, material science properties, and established biomechanical performance standards for bone fixation devices. This is demonstrated through direct physical measurements and observations during bench and cadaver tests. The comparison to predicate devices also establishes a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."

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

This information is not applicable. There is no "training set" for this type of device.

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The GraMedica opti-Toe Device is indicated for reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The GraMedica opti-Toe components are to be cemented in place and assembled for reconstruction of the toe. Patients should protect their weight-bearing only until soft tissue healing has occurred.

The GraMedica opti-Toe is comprised of two mated components (proximal and middle phalangeal) which join together to form a single intramedullary fixation unit. The implants are offered in two sizes, small and large, and the middle phalangeal component is offered with and without a 10 degree angulation.

The document provided is a 510(k) premarket notification from the FDA for a medical device called "opti-Toe". This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML devices is not present in this regulatory filing.

However, I can extract the non-clinical performance testing information that was conducted to support the substantial equivalence claim for the opti-Toe device.

Here's a summary of the non-clinical performance testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a numerical or categorical format for the non-clinical tests. Instead, the testing was performed to demonstrate the device's functional integrity and similarity to predicate devices. The "reported device performance" is the successful completion of these tests.

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

• Cadaveric Simulated Use Study: The document does not specify the number of cadavers used.
• Assembly/Disassembly Force, Static/Dynamic Bending: The document does not specify the number of devices or iterations tested for these mechanical evaluations.
• Data Provenance: The testing was non-clinical (laboratory and cadaveric) and conducted for regulatory submission purposes. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical trial with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. For non-clinical tests like mechanical and cadaveric studies, "ground truth" as it relates to expert consensus on clinical findings is not established. The "ground truth" for these tests would be the measured physical properties and observations of functionality.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically for clinical trials or expert label review, not for non-clinical mechanical or cadaveric testing.

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

No. An MRMC study is a type of clinical study generally used for diagnostic devices involving human readers evaluating medical images. This document describes a K-wire equivalent fixation device and its non-clinical testing, so an MRMC study was not conducted or applicable.

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

Not applicable. This device is a physical medical implant (a toe fixation device), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical tests:

• Cadaveric Simulated Use Study: "Ground truth" was the observed functionality and ease of use in a cadaveric model.
• Mechanical Testing (Assembly/Disassembly Force, Static/Dynamic Bending): "Ground truth" was the objective measurements of force and bending properties according to established engineering standards or internal protocols, likely compared against predicate device performance or relevant industry standards for similar devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI/ML device, this question is not relevant.

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The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

The provided text describes the 510(k) summary for the Apex Kirschner Wires and Steinmann Pins. It does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in performance testing sections for AI/ML-driven devices. Instead, it focuses on substantial equivalence to predicate devices based on design and materials.

However, I can extract the relevant information that is present and explain where the requested details are absent.

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

   This information is not provided in the document. The submission is a 510(k) for orthopedic fixation devices (Kirschner Wires and Steinmann Pins), which typically rely on material properties, mechanical strength, and biocompatibility rather than "performance" in the sense of an algorithm's output metrics like sensitivity or specificity.
   The document states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This implies that the 'acceptance criteria' are implicitly met if these characteristics are equivalent to legally marketed predicate devices, which are presumed safe and effective.

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

   This information is not applicable/provided for this type of device submission. There is no 'test set' in the context of an algorithm or diagnostic device. The evaluation is based on engineering specifications and comparison to predicate devices, not data from a clinical trial or dataset.

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 information is not applicable/provided. There is no ground truth established by experts for a test set, as this is a medical device (orthopedic pins) and not a diagnostic or AI-based product.

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

   This information is not applicable/provided. No adjudication method for a test set is mentioned because there is no such 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

   This information is not applicable/provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission concerns orthopedic hardware, not an AI system.

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

   This information is not applicable/provided. This device is a physical medical implant, not an algorithm.

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

   This information is not applicable/provided. Ground truth, as defined for algorithm performance, is not relevant here. The "truth" for this device lies in its material properties, manufacturing quality, and successful physical fixation as per its intended use, established through engineering standards and comparison to predicate devices.

8. The sample size for the training set

   This information is not applicable/provided. There is no 'training set' for this physical medical device.

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

   This information is not applicable/provided. There is no ground truth or training set for this device.

Summary of available information regarding the "study" proving device meets "acceptance criteria":

Based on the provided document, the "study" demonstrating the device meets "acceptance criteria" is a substantive equivalence comparison with legally marketed predicate devices.

• Study Design: A comparison of physical dimensions, materials, and technological characteristics of the Apex Kirschner Wires and Steinmann Pins to identified predicate devices:

  • Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215)
  • DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385)
  • OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555)
  • Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912)

• Acceptance Criteria (Implied): The device is considered to meet acceptance criteria if its physical dimensions, materials, and technological characteristics are "similar" or equivalent to the identified predicate devices, thereby establishing substantial equivalence in terms of safety and effectiveness for its intended use.

• Reported Device Performance: The document explicitly states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This statement serves as the 'reported performance' for the 510(k) process, indicating that the device design and materials are comparable to existing, approved devices.

• Data Provenance/Sample Size: Not applicable in the context of an AI/ML study. The 'data' consists of the specifications and characteristics of the Apex device and the predicate devices.

The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets regulatory requirements based on the comparative assessment.

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