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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 Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.

The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements. and extracutaneous bridge elements, which provide fixation of the skull relative to the torso to immobilize the cervical spine when used with a frame or surgical table adaptor.

The transcutaneous bone anchorage elements are titanium threaded skull pins. of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor.

Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.

This document describes a medical device, the Anjon Bremer Halo System, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device. Therefore, the questions related to acceptance criteria, study details for AI/ML performance, sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes are not applicable to the content provided.

The document focuses on:

• Device Description: The Anjon Bremer Halo System is composed of transcutaneous bone anchorage elements (titanium threaded skull pins) and extracutaneous bridge elements (crown or ring) for cervical spine immobilization and therapeutic traction.
• Indications for Use: To provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
• Predicate Devices: The device acts as its own predicate (K171863) and is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin (K915800) and the Bremer Halo System Titanium Skull Pin (K993099).
• Non-Clinical Testing: This section outlines the engineering and biocompatibility tests performed on the Anjon Bremer Halo System to ensure its safety and performance. This includes:
  • Testing of Skull Pins to failure under load (ASTM F1541).
  • Biocompatibility assessment (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity testing per ISO 10993).
  • Testing of the Halo for deformation under load (ASTM F1831).
  • Product and sterile barrier stability testing per ISO 11607-2, including post-gamma irradiation and accelerated aging.
  • Sterilization validation using the VDmax25 method (ISO 11137).
• Conclusion: Based on the non-clinical testing and comparison to predicate devices, the Anjon Bremer Halo System is concluded to be substantially equivalent.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text pertains to a traditional mechanical medical device.

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The DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of:

DYNAMIC MODE:

1. complex fracture-dislocations or fracture-subluxations, and pilon fractures of the interphalangeal (IP) joint;
2. Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;
3. Dupuytren's contracture

STATIC MODE:

1. Fractures of the phalanges and
2. interphalangeal (IP) joint arthrodesis.

The DigiFix TM External Fixation System Sterile Kit includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided sterile and are intended for single use only.

This submission describes a medical device, the "DigiFix Sterile Kit," which is a smooth or threaded metallic bone fixation fastener for external fixation. It is not an AI/ML device, hence the request for acceptance criteria and study details related to AI/ML performance is not applicable. The provided text refers to a traditional medical device and its clearance based on substantial equivalence to a predicate device.

Therefore, I cannot provide the information requested for AI/ML device performance. The document does not contain information about:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample size used for a test set or data provenance for an AI/ML model.
• Number of experts or their qualifications for establishing ground truth for an AI/ML model.
• Adjudication method for an AI/ML model's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for an AI/ML model.
• Standalone performance of an AI/ML algorithm.
• Type of ground truth used for an AI/ML model.
• Sample size for a training set or how ground truth was established for an AI/ML model.

The provided information focuses on the device's indications for use, its components, and the validation of its sterility and cleaning processes, which are standard for orthopedic fixation devices. The conclusion states that the device is substantially equivalent to predicate devices based on test results (sterilization and cleaning) and comparison, not on AI/ML performance metrics.

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The PIP Fix is indicated for the treatment of unstable dorsal fracture dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the PIP Fix alone is sufficient to obtain and maintain concentric reduction of the fracture dislocation during bone and soft tissue healing.

The PIP Fix is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture dislocation of the proximal interphalangeal (PIP) joint. This device is capable of exerting both palmar translation and distal length restoration forces on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the PIP Fix is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues.

The PIP Fix is installed by a surgeon in a healthcare facility / hospital environment. Included with the gamma irradiated, sterile PIP Fix is a Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. A Dorsal Bone Pin is inserted vertically into the middle phalanx. The device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating forces that hold the joint concentrically reduced. The device enables the surgeon to determine the distribution of the direction of the forces between palmar translation and distal length restoration. This is accomplished by rotating the Elastic Band posts about an arc concentric with the PIP joint axis such that the force vector resolution may be purely in a palmar translation direction or a combination of palmar translation and length restoration. An Angle Lock Screw locks the device in the chosen position to maintain the force distribution. A Tension Adjust Screw on the PIP Fix allows the surgeon to adjust the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to maintain joint alignment.

The PIP Fix is manufactured using metal and Ultem plastic. The Bone Pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only. The device is typically worn for 6 to 8 weeks depending on the rate of healing and the surgeon's assessment of the same. During this time, the Bone Pins are the only portion of the device contacting or penetrating the skin in a non-transient manner.

The provided text is a 510(k) summary for the PIP Fix device. It outlines the device's indications for use, its comparison to a predicate device, and performance data. However, it does not include a table of acceptance criteria and reported device performance with numerical values, nor does it describe a study that explicitly tested the device against such criteria in the way typically found for AI/ML device submissions.

The information provided focuses on demonstrating substantial equivalence to a predicate device for a mechanical external fixation device, not an AI/ML algorithm. Therefore, many of the requested items related to AI/ML specific studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or not present in this document.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present given the nature of the document:

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

This information is not provided in the document in the format of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding numerical performance results. The document instead discusses computational analyses comparing force generation and stress on components with a predicate device.

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

Not applicable/Not provided. This document describes a physical medical device (external fixator) and its mechanical properties, not a software algorithm that would typically have a "test set" in the context of AI/ML. The "performance data" refers to computational analysis of force and stress.

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/Not provided. This information is relevant for AI/ML diagnostic or prognostic devices where expert consensus is used to establish a "ground truth" for evaluating algorithm performance. This document does not describe such a study.

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

Not applicable/Not provided. Similar to point 3, this is relevant for expert ground truth establishment in AI/ML 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. This document does not mention an MRMC study or any study involving human readers with or without AI assistance. The device is a physical external fixator operated by a surgeon.

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

Not applicable. The device is a mechanical external fixator; there is no standalone algorithm performance to evaluate.

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

Not applicable. For the "performance data" presented (computational analysis), the "ground truth" is based on engineering principles and material properties, rather than clinical outcomes or pathological diagnoses. The assessment relies on computational models and material specifications to determine if the device components can withstand the forces generated.

8. The sample size for the training set:

Not applicable/Not provided. As there is no AI/ML algorithm, there is no training set mentioned.

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

Not applicable/Not provided.

Summary of available information relevant to "proving the device meets acceptance criteria" (within the context of a 510(k) for a mechanical device):

The "acceptance criteria" for this device, while not explicitly stated in a table with numerical thresholds, appear to be implicitly linked to demonstrating substantial equivalence to the predicate device and showing the device performs safely and effectively for its intended use. This is achieved through:

• Computational Analyses:
  • Force Performance: The PIP Fix's force performance is comparable to the predicate device when in palmar translation only positions.
  • Increased Length Restoration Force: The PIP Fix applies 5 times greater length restoration force than the predicate device in "translation & length restoration force" positions. This is a design enhancement over the predicate, addressing an unmet need.
  • Dorsal Pin Stress Analysis: A computational analysis was performed on the dorsal pin due to the increased length restoration force. This showed a 5x increase in bending stress.
    • Proof it meets acceptance implicitly: The reported bending stress remains significantly below the pin material yield strength. This implies the material and design are robust enough for the increased forces, thus meeting an implicit "acceptance criterion" of structural integrity.
• Bacterial Endotoxin Testing (BET):
  • Result: Detected endotoxin levels were less than the FDA guidance recommended limit of 20.0 EU/device.
  • Proof it meets acceptance: This directly demonstrates the device meets a specific biological safety "acceptance criterion" related to sterility.

Study/Evidence that proves the device meets the implicit acceptance criteria:

The "study" referenced for performance is primarily computational analysis and a Bacterial Endotoxin Test. These are not clinical studies, but engineering and laboratory tests.

• Computational Analyses: These involved modeling the forces and stresses on the device components (specifically, the dorsal pin) under the conditions of use, especially considering the increased length restoration force compared to the predicate.
• Bacterial Endotoxin Testing: This was a laboratory test performed on the implantable components of the device to quantify endotoxin levels.

In conclusion, for this specific mechanical device, the "acceptance criteria" and "proof" are demonstrated through engineering analyses and specific lab tests to ensure mechanical integrity and biological safety, aligned with the requirements for substantial equivalence to a predicate device, rather than through large-scale clinical trials or AI/ML specific performance studies.

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The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.

The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements, and extracutaneous bridge elements, which provide fixation of the torso to immobilize the cervical spine when used with a frame or surgical table adaptor. The transcutaneous bone anchorage elements are titanium threaded skull pins, of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor. All materials are MRI/CT conditional.

The provided text is a 510(k) summary for the Anjon Bremer Halo System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove acceptance criteria for device performance in the context of clinical metrics like sensitivity, specificity, accuracy, or similar performance measures often associated with AI/ML devices.

Therefore, many of the requested sections about acceptance criteria and study details for an AI/ML device are not applicable to this document. The Anjon Bremer Halo System is a medical device (a halo system for cervical spine immobilization and traction), not an AI/ML diagnostic or prognostic tool.

Here's a breakdown based on the information available in the provided text:

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

The document does not specify "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity for a clinical task. Instead, the "acceptance criteria" for regulatory clearance through a 510(k) pathway are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is not in clinical outcomes, but rather in the form of technological characteristics comparison.

Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is a 510(k) Substantial Equivalence Comparison, not a clinical trial or performance study against specific clinical endpoints. The document implicitly claims "acceptance" of the device by the FDA through the 510(k) clearance process, which is based on demonstrating that the device is as safe and effective as a legally marketed predicate device. This is achieved by comparing technological characteristics and indications for use.

The conclusion states: "The Anjon Bremer Halo System is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin predicate device (Primary Predicate - K915800) and Bremer Halo System Titanium Skull Pin (Reference predicate - K993099). In addition to conclusions from performance data comparisons, the devices have the same "Indications for Use," and are available by prescription only, and are for single use only."

The "performance data comparisons" mentioned in the conclusion would refer to analyses (not explicitly detailed in this summary) that demonstrate the subject device performs similarly to the predicate devices with respect to mechanical properties, material properties, and functionality relevant to cervical spine immobilization and traction. This likely includes bench testing for strength, durability, torque characteristics, and material biocompatibility, rather than clinical efficacy data for patients.

Regarding the specific questions that are not applicable to this type of device and submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device and submission. There is no "test set" of clinical data in the context of an AI/ML device. The "data" involves device specifications and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth is established with expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical ground truth for an AI/ML device. The "ground truth" for this submission is the accepted safety and effectiveness of the legally marketed predicate devices, against which the subject device is compared via its technical specifications and intended use.
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.

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The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:

• · bone fracture fixation;
• · osteotomy:
• · arthrodesis:
• · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
• · bone reconstruction procedures.

The Medline ReNewal Reprocessed Stryker External Fixation Devices are intended to provide temporary stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments. Additionally, the devices may be used for elective orthopedic interventions such as limb lengthening. Devices in the scope of this document include various rods and clamps/connectors that are assembled external to the operative or injury focus and will not be in direct patient contact.

This document describes the 510(k) premarket notification for Medline ReNewal Reprocessed Stryker External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with numerical acceptance criteria and reported device performance values. Instead, it broadly states that "The functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests."

The functional performance studies mentioned are:

• Simulated Use and Artificial Soiling: Implies testing the device under simulated clinical conditions, including exposure to typical biological contaminants. The acceptance criterion would likely be successful cleaning and restoration of functionality after reprocessing.
• Structural Integrity: This would involve mechanical testing to ensure the reprocessed device maintains its structural strength and integrity. Acceptance criteria would likely be a comparison to the original equipment manufacturer (OEM) specifications or to the predicate device's performance, ensuring no degradation after reprocessing.
• Carbon Rod Stiffness per the 4-point bend test (pre-conditioning): Measures the stiffness of carbon rods before they are subjected to simulated use or conditioning. Acceptance criterion would be that the stiffness matches or is within an acceptable range of the OEM or predicate device specifications.
• Cyclical Axial Compression and Tension Bending Test: Evaluates the fatigue life and mechanical durability of the device under repeated loading. Acceptance criterion would be successful completion of a specified number of cycles without failure, demonstrating performance equivalent to the predicate.
• Carbon Rod Stiffness per the 4-point bend test (post conditioning): Measures the stiffness of carbon rods after they have undergone simulated use or conditioning. The acceptance criterion would be that the stiffness remains within acceptable limits and comparable to the predicate device, indicating no significant material degradation from reprocessing or use.
• Disassembly and Reassembly (pre-and post-sterilization): Assesses the ability of the device to be taken apart and put back together correctly and safely, both before its first use (after reprocessing) and after sterilization. Acceptance would involve visual inspection and functional checks to ensure proper fit, function, and absence of damage.
• Cleaning:
  • Visual Inspection: Ensures no visible residue remains after cleaning. Acceptance criterion is no visible residue.
  • Cleaning Efficacy (residual protein and residual carbohydrate): Quantifies residual organic matter after cleaning. Acceptance criteria would be specific threshold levels for residual protein and carbohydrate, typically very low to ensure patient safety and effective sterilization.

Reported Device Performance: The document generally states that the device performance for these tests has been "determined to be substantially equivalent to the predicate device." Specific numerical results for each test are not provided in this summary.

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

The document does not specify the exact sample sizes used for each of the performance tests.
The data provenance is implied to be laboratory testing conducted by Medline ReNewal, as part of their 510(k) submission. It would be considered prospective for the purpose of demonstrating the safety and effectiveness of their reprocessed devices. The country of origin of the data is not explicitly stated but is likely the USA, where Medline ReNewal is located.

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

This information is not provided in the document. The type of testing described (mechanical, cleaning efficacy) typically relies on objective measurements against established engineering specifications rather than expert consensus on a "ground truth" in the way a diagnostic AI might. Therefore, the concept of "experts establishing ground truth" in the context of clinical images or conditions is less applicable here. The "ground truth" for the performance tests would be the established specifications of the original device and recognized industry standards for reprocessed medical devices.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of performance testing described for a reprocessed external fixation device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers evaluating medical images or patient outcomes, which is not the nature of this submission.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what this reprocessed medical device is.

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

A standalone performance evaluation was not done. This concept is relevant for AI algorithms. The device under consideration is a physical medical device (reprocessed external fixation components), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described would be:

• Original Equipment Manufacturer (OEM) Specifications: The performance characteristics (e.g., structural integrity, stiffness) of the new, original Stryker External Fixation Devices.
• Industry Standards: Applicable standards for mechanical testing of external fixation devices and cleaning/sterilization of reprocessed medical devices.
• Objective Measurements: Results of physical, chemical, and mechanical tests conducted on the reprocessed devices.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI models. This document describes a reprocessed physical medical device, not an AI or algorithm. Therefore, there is no training set in the context of AI. The "training" for the reprocessing process itself would involve establishing and validating the reprocessing procedures (cleaning, disinfection, sterilization, functional testing), which were applied to a set number of devices for the performance studies mentioned. The document does not specify the number of devices used to develop or validate the reprocessing protocols.

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

Since there is no AI training set, this question is not applicable. The "ground truth" for the reprocessing procedures would be validated through rigorous testing against established industry standards and internal quality control measures to ensure that the reprocessed devices meet the same performance and safety standards as the original devices.

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The DIGIFIX™ External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint; STATIC MODE: 1) comminuted fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

The DigiFix™ External Fixation System includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided non-sterile and are intended for single use only.

The provided text does not contain information about acceptance criteria or a study proving that the DigiFix™ External Fixation System meets such criteria. Instead, it states that
"A device which has essentially the same design and materials as the predicate should not require testing unless there is new information which raises safety and effectiveness concerns. The DigiFix™ device utilizes materials and has design features that are the predicate devices. Evaluation of the material, dimensions and K-wires demonstrates that the subject device has a higher estimated rigidity than the predicate devices. Thus, no performance testing is necessary to support substantial equivalence of the device."

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets those criteria.

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The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The indications for use of metallic external fixation devices include:

• Bone fracture fixation
• Osteotomy
• Arthrodesis
• Correction of deformity
• Revision procedures where other treatments or devices have been unsuccessful
• Bone reconstruction procedures

The Hoffmann II External Fixation System originally cleared under K952730, K971755, K003211 and K031941 includes clamps, couplings and rods used in conjunction with half pins or transfixing pins of the Hoffmann External Fixation System cleared under K861766 and is intended to be used for the stabilization of fractures of the tibia, femur, liumerus, radius or pelvis.

This special 510(k) submission is intended to provide an alternate stainless steel material (Biodir 108) to manufacture Hoffinann II coupling components: Currently the subject Hoffmann II components are manufactured from stainless steel, Custom 455.

Here's an analysis of the provided text regarding the Hoffmann II External Fixation System Line Extension (K102885).

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 a distinct "test set" in the context of clinical data or human subject testing. The evaluation was based on material analysis and testing of the device components themselves. Therefore:

• Sample size for test set: Not applicable in the context of human subjects or clinical cases. The "test set" would refer to the physical components manufactured from the new and old materials. The exact number of components tested is not provided, but it's implied that enough were tested to draw a conclusion of equivalence.
• Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data, as this was a materials-based study. The testing was conducted by Howmedica Osteonics Corp.

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

Not applicable. The ground truth for this submission was based on engineering and materials science standards and testing protocols, not on expert clinical opinion or interpretation of medical images/outcomes. The "experts" involved would be materials scientists, engineers, and quality assurance personnel responsible for conducting and interpreting the physical and mechanical tests. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. This was a technical/materials equivalence study, not a clinical study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment of "equivalent stability and performance" would be based on predefined engineering metrics and statistical comparisons.

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

No. An MRMC study is not mentioned and would not be relevant for this type of submission, which focuses on material equivalence for an existing external fixation system. This involves no AI component or human readers interpreting data.

6. Standalone Performance Study

Yes, in a way. The "analysis and testing" of the alternate material against the existing material for the Hoffmann II coupling components can be considered a standalone performance study in the context of the device's functional integrity and material properties. It describes the performance of the device components (without human intervention in its functionality as an AI would) against established benchmarks (the predicate device's material).

7. Type of Ground Truth Used

The ground truth used was engineering and materials performance data obtained from in vitro testing. This includes metrics related to stability, mechanical properties (e.g., strength, stiffness, fatigue resistance), and potentially biocompatibility, ensuring that the new material performs equivalently to the predicate device's material.

8. Sample Size for the Training Set

Not applicable. This submission is for a medical device's material change, not an AI/machine learning algorithm. Therefore, there is no "training set" in the traditional sense.

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

Not applicable, as there is no training set for an AI algorithm.

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The LAKI device is intended to be used for fixation of bone fractures of long bones in fingers. The LAKI device is a semi-invasive device intended to be attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

This 510(k) consists on the submission of an evolution of an external fixation device. The LAKI Hand Fixation System provides opportunity to patients to develop solid bone re-growth in cases of fractures, pseudo-arthrosis, and limb lengthening by use of modular elements, rods, and nuts. The LAKI utilizes a threaded rod bound to two semi modular elements with nuts which allows the former to be locked in the most suitable position for each specific case. Kirschner wires are also used for stabilization. All invasive components of the LAKI Hand Fixation System are made of 316L stainless steel. External locking connector components are all made of Ti6AL4V titanium alloy.

The provided text is a 510(k) summary for the LAKI Hand Fixation System. It describes the device, its indications for use, and claims substantial equivalence to a predicate device (LIMA SEM Modular External Stabilizer, K880282). Crucially, the document states under "V. Performance Data": "Please see 510(k) submission for the SEM Modular External Stabilizer, K880282."

This means that a separate document (K880282) would contain the performance data, acceptance criteria, and details of any studies proving the device meets those criteria. The current document (K082679) does not include this information directly.

Therefore, I cannot provide the requested table and study details based solely on the provided text. The document explicitly defers to the predicate device's 510(k) for performance data.

Based on the provided text for K082679, I can only state the following:

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

• Not available in the provided text. The document directs to K880282 for performance data.

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

• Not available in the provided text. The document directs to K880282 for performance 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 available in the provided text. The document directs to K880282 for performance data.

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

• Not available in the provided text. The document directs to K880282 for performance data.

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 is a hardware medical device (fixation system), not an AI-assisted diagnostic device that would involve human readers.

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

• Not applicable. This is a hardware medical device, not an algorithm.

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

• Not available in the provided text. The document directs to K880282 for performance data.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. This is a hardware medical device, not a machine learning algorithm.

To answer your request comprehensively, one would need to access and review the 510(k) submission for the LIMA SEM Modular External Stabilizer (K880282).

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The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.

The F3 Fractured Finger Fixator is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint. This device exerts a volarly translating force on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the F3 is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues.

Included with the F3 is a custom designed Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. The Dorsal Bone Pin inserted vertically into the middle phalanx. The F3 device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating force that holds the joint concentrically reduced. A Tension Adjust Screw on the F3 allows the surgeon to "fine frune" the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to me ' tain joint alignment.

The F3 Fractured Finger Fixator is manufactured using metal and plastic. The bone pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only.

The provided document is a 510(k) summary for the F3 Fractured Finger Fixator. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) submission for novel devices.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of available information related to performance and testing (though not presented as acceptance criteria or a formal study):

The document mentions that the F3 Fractured Finger Fixator is designed to "obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint." It also states that the device allows "full active flexion and extension during healing of the bone and soft tissues."

The comparison to the predicate device (Compass PIP Joint Hinge) indicates that "The F3 is comparable to the predicate device with respect to function and application technique." However, this is a statement of design and intended use equivalence, not a direct measurement against predefined performance acceptance criteria from a clinical study. The FDA's 510(k) review determines "substantial equivalence" based on similar intended use, technological characteristics, and safety and effectiveness, rather than requiring new clinical data demonstrating performance against specific quantitative criteria if substantial equivalence can be shown otherwise.

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