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The HBL Blade Assembly is indicated for use with the 3M Agee Inside Job Carpal Tunnel Release System or MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel in the elbow

The HBL Blade Assembly is a surgical device designed to divide the ligament during an endoscopic carpal tunnel release (ECTR) or the fascia during an endoscopic cubital tunnel release (ECuTR). This device is capable of elevating a cutting blade from a retracted position within the cannula to an exposed position for cutting the ligament or fascia. Once the ligament or fascia has been divided, the cutting blade can be returned to a safe position within the cannula.
The HBL Blade Assembly is composed of a probe assembly that is fabricated using medical grade injection molded plastic, and both a spring and cutting blade that are fabricated using stainless steel. The Blade Assembly is provided sterile and designed for single use.

The provided text is a 510(k) summary for the HBL Blade Assembly. It describes the device, its indications for use, comparison to a predicate device, and performance data. However, it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria using an AI/ML context.

The document discusses performance data related to mechanical aspects and a cadaveric study, which are typical for mechanical medical devices, not AI/ML-driven devices. There is no mention of algorithms, machine learning, AI models, or human-in-the-loop studies in the context of diagnostic accuracy improvement.

Therefore, I cannot provide the requested information from the given text as it relates to an AI/ML device. The device described, the HBL Blade Assembly, is a surgical tool, and its performance evaluation involves physical and mechanical properties, as well as surgical use in a cadaveric setting, not the kind of AI/ML performance metrics you've asked about.

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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 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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Fracture reduction and external fixation for treatment of distal radius fractures.

The WristJack ORIF System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins.

The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, carbon fiber, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

The provided text is a 510(k) summary for the WristJack ORIF System, an external fixation system for distal radius fractures. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI/CADe device would.

Therefore, the information requested about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic devices, is largely not present in this type of regulatory submission.

Here's an attempt to answer based on the provided text, highlighting what is (and isn't) available:

1. 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)

• Not applicable / Not provided. This document is a premarket notification (510(k)) for a medical device (external fixator), not an AI/CADe device. The assessment of substantial equivalence relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than a clinical study with a "test set" of patient data in the context of an AI algorithm. There is no mention of patient data, clinical trial, or geographical origin of 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 / Not provided. The concept of "ground truth" established by experts for a test set is relevant for AI or diagnostic performance studies. For this external fixator, the "ground truth" for its safety and effectiveness is largely established by its similarity to a previously cleared predicate device, and the engineering and material specifications provided in the submission. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices, Office of Device Evaluation) are the experts who reviewed the submission.

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

• Not applicable / Not provided. This concept is for resolving discrepancies in expert interpretations within an AI/diagnostic study.

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. An MRMC study is specific to evaluating diagnostic performance, often with AI assistance. This device is an external fixator, not an AI/CADe system.

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

• No. This question is also specific to AI algorithms.

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

• The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to a predicate device. This involves comparing technological characteristics, materials, and intended use to established standards of safety and effectiveness, rather than a clinical "ground truth" from patient data. The basis for this is engineering comparison, material specifications, and regulatory precedent.

8. The sample size for the training set

• Not applicable / Not provided. This concept applies to AI algorithm development.

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

• Not applicable / Not provided. This concept applies to AI algorithm development.

In summary, the provided document is a regulatory submission for a physical medical device (an external fixator). It demonstrates compliance through substantial equivalence to a predicate device, rather than through a clinical study designed to meet specific performance metrics with patient data, which would be typical for an AI algorithm or diagnostic device.

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Fracture reduction and external fixation for treatment of distal radius fractures.

The WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction frame (fixator), application instrumentation and skeletal fixation pins. The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or clinical trial data.

The document is a 510(k) summary for a medical device called the "WristJack System (remanufactured)". This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting clinical study results to prove performance against specific acceptance criteria.

Here's why the requested information cannot be found in the provided text:

• Acceptance Criteria and Device Performance: The document explicitly states "No performance standards exist for this device." and primarily discusses the device's technological characteristics and its similarity to a predicate device. It doesn't present any performance metrics or acceptance criteria for those metrics.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Because no performance study is described, all these related details are absent from the text. The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often through comparisons of materials, design, and intended use, rather than new clinical outcome studies.

In summary, the provided document is a regulatory filing focused on substantial equivalence, not a clinical study report. Therefore, it does not contain the information requested about acceptance criteria and device performance studies.

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The Hand Biomechanics Lab, Inc. Digit Widget is intended for use in treating PIP joint flexion contractures with an associated loss of range of motion.

The Digit Widget is an external fixation system designed to effect rotation of an injured or diseased finger, to help regain, maintain, or increase the range of motion of the proximal interphalangeal (PIP) joint. It utilizes standard small diameter bone pin (Kirschner wire) fixation techniques and procedures for placement. The device acts about the PIP joint and allows some adjustability to permit fine tunive to the joint's axis. During treatinent, the surgeon or hand therapist (under order from the physician) may be required to periodically adjust the torque provided by the traction mechanism, by changing or adding orthodontic elastic can be removed temporarily to permit active range of motion exercise. The Digit Widget traction device is made from plastic and materials. Fixation pins (Kirschner wires) are made from implant grade stainless steel. An included wrist splint is made of neoprene and nylon, with Velcro attachment provisions. All components are designed for single use only.

The Digit Widget 510(k) summary explicitly states:

Clinical Tests: None

This means that no studies were conducted to prove the device meets specific acceptance criteria. Therefore, most of the requested information cannot be provided from the given document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not defined in the document.
• Reported Device Performance: Not reported as no clinical tests were performed.

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 as no clinical tests were performed.

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 as no clinical tests were performed.

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

• Not applicable as no clinical tests were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done, as no clinical tests were performed. The device is also an external fixation device, not an AI-assisted diagnostic tool.

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

• Not applicable as this is a physical medical device, not an algorithm. No standalone performance study was performed.

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

• Not applicable as no clinical tests were performed.

8. The sample size for the training set

• Not applicable as no clinical tests were performed and no machine learning algorithm is involved.

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

• Not applicable as no clinical tests were performed and no machine learning algorithm is involved.

Conclusion from the document:

The regulatory clearance for the Digit Widget (K992970) was based on substantial equivalence to predicate devices (specifically, the Proximal Interphalangeal (PIP) Joint External Fixation device (Compass® Proximal Interphalangeal Joint Hinge) marketed by Smith Nephew Richards). This means the FDA determined the new device was as safe and effective as a legally marketed predicate device, without requiring new clinical performance data. The submission explicitly states "Clinical Tests: None."

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Fracture reduction and external fixation for treatment of distal radius fractures.

The Agee-WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins.

The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

The provided text is a 510(k) summary for the Agee-WristJack Fracture Reduction System (sterile version). It mainly focuses on demonstrating substantial equivalence to a predicate device by highlighting that the only difference is the sterility of the new device.

Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a performance study for this specific device.

The document states:

• "All the device components and materials of the Agee-WristJack Fracture Reduction System (sterile version) are identical to the device components and materials of the predicate device, except this device is delivered sterile. The predicate device requires customer sterilization prior to use."
• "No performance standards exist for this device."

This indicates that the submission relies on the established safety and effectiveness of the non-sterile predicate device, with the sterile aspect being the primary change, likely supported by sterilization validation studies, not clinical performance studies comparing the new device's efficacy.

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