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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 TOEGRIP® is intended for toes for general use in skeletally mature individuals undergoing surgery limited to interdigital fusion.

The TOEGRIP® device is intended to be permanently implanted without any other additional device as an intramedullary bone fastener device for toes or fingers.

The TOEGRIP® device is indicated for small bone reconstruction limited to interdigital fusion of toes in the following cases, listed in random order:

• . Rigid PIP joints deformities
• . Rigid hammertoes deformities
• . Claw toes deformities (PIP and DIP joints)
• Revision hammertoes surgeries .
• . Shortening osteotomies of the proximal phalanx

The TOEGRIP® device consists of a monobloc implant with three flexible prongs inserted intramedullary into each part of phalanx The prongs are linked by a T-shaped beam. The fixation concept is based on a press-fit contact due to its tapered shape and the sharp macrostructures once impacted.
The TOEGRIP® device is intended for single use only, and is available in a range of 5 sizes with 3 possible degrees: 0°, 10° or 20°.
The TOEGRIP® device is manufactured with material according to the ISO-10993, ZENIVA® PEEK.
The feature design of the TOEGRIP® is substantially equivalent to the design features of other devices previously cleared for market.

The Synchro-Medical Toe Grip Device underwent nonclinical testing to demonstrate its substantial equivalence to predicate devices.

1. Acceptance Criteria and Device Performance:

The document states that the Synchro-Medical Toe Grip Device met the acceptance criteria for the tests performed. However, the specific quantitative acceptance criteria or the reported device performance metrics are not detailed in the provided text.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document does not explicitly state the sample size used for the nonclinical tests (Static Four-point Bending Test and Dynamic Four-point Bending Test).
• Data Provenance: The tests were nonclinical (bench testing) and therefore do not have data provenance related to country of origin or retrospective/prospective human data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The study involved nonclinical mechanical testing, not human expert assessment for ground truth.

4. Adjudication Method for Test Set:

Not applicable. The study involved nonclinical mechanical testing, not human expert assessment requiring adjudication.

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

No. The document explicitly states, "No clinical tests were performed." Therefore, an MRMC comparative effectiveness study was not conducted.

6. Standalone Performance Study:

Yes, a standalone study (nonclinical mechanical tests) was performed for the algorithm/device. The device's performance was evaluated through:

• Static Four-point Bending Test
• Dynamic Four-point Bending Test

7. Type of Ground Truth Used:

The "ground truth" for these nonclinical tests would be the established engineering standards and specifications for bone fixation devices, against which the device's mechanical properties (e.g., bending strength, fatigue resistance) were measured.

8. Sample Size for Training Set:

Not applicable. This device is a physical implant, not a software algorithm that requires a training set in the context of machine learning.

9. How Ground Truth for Training Set was Established:

Not applicable. This device is a physical implant, not a software algorithm that requires ground truth for a training set.

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The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

The provided text describes a 510(k) premarket notification for a medical device called HammerLock® 2. This document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing, rather than clinical study data involving AI or human interpretation. Therefore, many of the requested elements for AI/imaging studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

For the remaining points, please note that this is a 510(k) summary for a mechanical medical device (implant) and not an AI or imaging diagnostic device. Therefore, many of the questions are not applicable to this document.

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: Not explicitly stated as a numerical sample size of "devices" in the same way a clinical trial would report patients. For mechanical testing, samples of the device (HammerLock® 2) and the predicate (K131640 HammerLock®) were used for each test. The ASTM standards (F382-99 for bending, F2129-08 for corrosion) would specify the minimum number of samples required for robust testing, but these numbers are not detailed in the summary.
   • Data Provenance: The data is generated from laboratory bench testing conducted in accordance with ASTM standards. The summary does not specify the country of origin of the lab or if it was prospective/retrospective; however, bench testing is inherently prospective in its execution (i.e., new tests are run for the new device).

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 Applicable. This document describes mechanical testing of an orthopedic implant, not an diagnostic imaging device that requires interpretation by medical experts to establish ground truth.

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

   • Not Applicable. As above, this pertains to expert review of diagnostic results, which is not relevant to this device's testing. Mechanical testing results are objective measurements (e.g., stiffness values, corrosion rates), not subject to expert adjudication in this context.

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. No MRMC study was performed as this is a device for surgical implantation, not an AI or imaging diagnostic tool that assists human readers.

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

   • Not Applicable. This is a mechanical implant, not an algorithm.

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

   • For Mechanical Testing: The "ground truth" is defined by the objective performance parameters (stiffness, strength, corrosion resistance) as measured against established ASTM standards and compared to a legally marketed predicate device. The "ground truth" for the predicate's performance is its previously characterized mechanical properties.
   • For Substantial Equivalence: The ultimate "ground truth" being demonstrated is that the HammerLock® 2 is as safe and effective as its predicate.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

   • Not Applicable. See point 8.

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The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force. This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.

The provided text describes a 510(k) premarket notification for a medical device called HammerLock. This is a regulatory submission for a medical device seeking clearance to market, demonstrating substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving device performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel AI software would.

Instead, the "study" mentioned here is primarily bench testing to demonstrate that the upgraded device maintains the same mechanical and material properties as its predicate.

Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, or ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI performance evaluations, which are not detailed here.

Here's a breakdown based on the information provided:

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance:

Study Details

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: Not specified for the bench tests. Typically, these involve a small number of representative samples for mechanical and material testing.
• Data Provenance: Not applicable. The "data" here refers to physical properties measured in a laboratory setting, not patient data.

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 Applicable. Bench testing does not involve human experts establishing ground truth in the clinical sense. The "ground truth" is defined by the objective physical properties and standards (ASTM F382-99, ASTM F2129-08).

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

• Not Applicable. Adjudication methods are relevant for subjective human assessments, not direct physical measurements in bench testing.

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 physical medical implant, not an AI or imaging device involving human readers or AI assistance.

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

• No. This is a physical medical implant, not an algorithm.

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

• For mechanical and corrosion resistance: Objective physical measurements against established ASTM standards and comparison to predicate devices' measured properties.

8. The sample size for the training set:

• Not Applicable. This device did not involve a "training set" in the context of machine learning or clinical trials. Bench testing does not have a training phase; it's a direct evaluation of manufactured samples.

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

• Not Applicable. As there is no training set mentioned, this question is not relevant.

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