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The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Valgus. Hallux Rigidus, and an unstable or painful MTP ioint. The Accu-Joint Hemi Implant is intended to be used with bone cement.

The metatarsal head and phalangeal base may not be used together at the same joint.

The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemi-arthroplasty and are not used together to create a joint. The Accu-Joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.

The purpose of this submission is to offer a sterile packaged option of the Accu-Joint Hemi Implant.

The provided text is a 510(k) Summary for the Accu-Joint Hemi Implant, focusing on an administrative change regarding the sterility of the device (from non-sterile to sterile packaged). It does not describe a study involving an AI/software device or a comparative effectiveness study with human readers.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies, as these concepts are not applicable to the content of this document.

The document discusses:

• Device: Accu-Joint Hemi Implant (a toe joint prosthesis).
• Purpose of current submission (K240268): To offer a sterile packaged option of the Accu-Joint Hemi Implant, which was previously cleared as non-sterile (under K200951).
• Key finding: The device is substantially equivalent to its predicate (K200951, the non-sterile version of the same implant) because the change in sterility status does not affect its safety and effectiveness.
• Performance Data discussed: This pertains to validation of the sterilization process and sterile packaging, not the performance of an AI algorithm or human readers.
  • Sterilization Validation: Per ISO 11135.
  • Sterile Packaging Validation: Per ISO 11607-2, ASTM D4169, ASTM F188, and ASTM F1929.
  • Mechanical Testing: Screw testing per ASTM F543 and dynamic bending testing were previously performed for the predicate device (K200951) and were not repeated for this submission as the sterilization change does not affect mechanical performance.

In summary, this document is about a medical implant's sterility change, not an AI or software device. Thus, the specific questions posed about AI device acceptance criteria and study methodologies are not applicable here.

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The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock.

Indications include:

• Hallux valgus or Hallux limitus
• Hallux rigidus
• Unstable or painful metatarsallphalangeal (MTP) joint

The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component (four sizes for each component) designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. The implants are made from Cobalt Chrome per ASTM F-1537.

This document is a 510(k) summary for the Montross Extremity Medical Hemi Implant System, a medical device. The document describes the device, its intended use, indications for use, and a summary of nonclinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information pertaining to AI/ML device performance or studies with acceptance criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods typically associated with such studies.

Therefore, I cannot extract the requested information using the provided text. The device described is a physical implant, not an AI-powered diagnostic or predictive tool, and thus the acceptance criteria and study information requested (e.g., related to multi-reader multi-case studies, standalone algorithm performance, ground truth establishment) are not applicable to this submission.

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The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The BioPoly Lesser Toe Hemiarthroplasty Implant is a hemiarthroplasty device specifically designed to restore the articular surface of the lesser metatarsal bones in patients with degenerative and post-traumatic arthritis.

The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6A1-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.

The provided text describes the 510(k) summary for the BioPoly Lesser Toe Hemiarthroplasty Implant, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and performance data for the mechanical testing of the device.

Acceptance Criteria and Device Performance for BioPoly Lesser Toe Hemiarthroplasty Implant

Explanation for non-applicable AI/ML categories:

• Sample size used for the test set and the data provenance: Not applicable. This concerns mechanical testing of a physical implant, not data-driven evaluation of an AI/ML model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
• 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 human reader involvement or AI assistance is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims is based on established engineering test standards and predefined acceptance criteria for mechanical properties (e.g., fixation strength, shear strength, fatigue resistance, wear characteristics).
• The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

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The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.

The restor3d MTP Implant is a sterile, single use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement.

The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished.

The provided document is a 510(k) premarket notification for a medical device called the "restor3d MTP Implant". It focuses on establishing substantial equivalence to a predicate device rather than describing an AI/ML powered device or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the information related to the device's performance testing to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes a set of performance tests conducted to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the restor3d MTP Implant performs similarly to or meets the standards demonstrated by the predicate device for the specified tests.

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

This document does not describe tests related to AI/ML or diagnostic performance based on data sets. The tests mentioned are mechanical and material property tests of the physical implant. Therefore, "sample size for the test set" in the context of image data or patient data, and "data provenance" (country of origin, retrospective/prospective) are not applicable or mentioned.

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

Not applicable, as this is a physical medical device (implant) and the document describes mechanical/material testing, not diagnostic performance evaluated by experts.

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

Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies, which is not the subject 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

Not applicable. This document is for a physical orthopedic implant, not an AI/ML-powered diagnostic tool.

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

Not applicable. This document is for a physical orthopedic implant, not an AI/ML algorithm.

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

For the mechanical and material tests described, the "ground truth" would be established by adherence to recognized engineering standards and test methods. For example, material properties are verified against industry standards for cobalt-chromium alloys, and mechanical tests (compression, bending, shear, fatigue, abrasion) would be assessed against benchmarks derived from the predicate device's performance or industry-accepted performance criteria for such implants. The document does not specify these detailed standards but implies compliance with generally accepted testing methodologies for orthopedic implants.

8. The sample size for the training set

Not applicable. There is no mention of an AI/ML component or a training set.

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

Not applicable. There is no mention of an AI/ML component or a training set.

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The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The BioPoly Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis.

The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6Al-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.

The provided text describes a 510(k) premarket notification for the BioPoly Great Toe Hemiarthroplasty Implant. This document focuses on the substantial equivalence of the device to existing predicate devices, rather than an AI/ML medical device. Therefore, a table for "acceptance criteria and reported device performance" as typically understood for AI/ML devices (e.g., sensitivity, specificity, AUC) and other details about an AI/ML study are not applicable or extractable from this document.

However, I can extract the performance testing summaries for the device as described, which demonstrate its mechanical and material properties.

Performance Testing Summary for BioPoly Great Toe Hemiarthroplasty Implant (Not an AI/ML device)

Non-Applicable Sections for this Device (as it is not an AI/ML medical device):

The following information is specifically requested for Artificial Intelligence/Machine Learning (AI/ML) medical devices and is not applicable to the BioPoly Great Toe Hemiarthroplasty Implant, which is a physical implant, not a software device that relies on AI/ML algorithms for its function. Therefore, the document does not contain information on these points:

1. Sample size used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Accu-Joint Hemi Implant is intended to be used with bone cement.

The metatarsal head and phalangeal base may not be used together at the same joint.

The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemiarthroplasty and are not used together to create a joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.

The provided text describes a 510(k) premarket notification for a medical device called the "Accu-Joint Hemi Implant," which is a toe joint phalangeal prosthesis. The document details the device's characteristics, indications for use, and performance data from non-clinical testing.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, as typically understood for an AI/ML-based device validation (which would involve metrics like sensitivity, specificity, F1-scores, ROC curves, etc.). The performance data mentioned refers to mechanical testing (static torsion, driving torque, static pullout, dynamic bending) of the physical implant itself, comparing its physical strength to predicate devices. There is no mention of "acceptance criteria" related to diagnostic or evaluative performance, nor details about a "study" involving a test set, expert ground truth, or MRMC studies.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for diagnostic performance, test set details, ground truth establishment, expert involvement, and statistical findings of an AI/ML study) is absent from the provided text.

The text focuses on establishing substantial equivalence based on:

• Physical characteristics (materials, insertion method, size, hole)
• Indications for Use
• Mechanical strength testing (demonstrating it's sufficient for intended use and equivalent to predicates)

It's a clearance for a physical orthopedic implant, not an AI/ML diagnostic or assistive device, which explains the lack of the requested AI/ML specific validation information.

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Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.

The Arthrosurface MTP implant incorporates an articular resurfacing component and a taper post component that mate together via a morse taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component.

Fixation components are being included in the system that contain an additional ring of material intended to improve stabilization in a first metatarsal that presents with a distal bone void. The articulating component and taper configuration are unchanged. The phalangeal implant is unchanged.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for an AI/algorithm-based medical device.

The document is a 510(k) premarket notification for the BOSS Toe Fixation System, which is a physical implant (a hemi-arthroplasty implant for the metatarsophalangeal joint).

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance (for an algorithm)
• Sample size used for the test set and the data provenance (for an algorithm)
• Number of experts used to establish the ground truth for the test set and their qualifications (for an algorithm)
• Adjudication method (for an algorithm's ground truth)
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone performance study was done (for an algorithm)
• The type of ground truth used (for an algorithm)
• The sample size for the training set (for an algorithm)
• How the ground truth for the training set was established (for an algorithm)

The document focuses on demonstrating substantial equivalence to an existing predicate device based on its indications for use, operating principle, materials, instrumentation, packaging, sterilization, and non-clinical tests (mechanical strength, cadaveric evaluation, bacterial endotoxins test). These tests are standard for a physical implant, not for an AI/algorithm.

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The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.

The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

It appears you've provided a 510(k) Premarket Notification document for a medical device: the Vilex Cannulated Hemi Implant (CHI).

However, this document describes a joint implant, not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. The acceptance criteria and supporting studies described in this document relate to the mechanical performance and biocompatibility of a physical implant, not the performance of an algorithm or the accuracy of a diagnostic reading.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic or image analysis device (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

The performance data section (VII. Performance Data) for this implant focuses on:

• Engineering analyses: Bending Stress, Shear Stress, Geometric Analysis, Surface Area Analysis. These are tests to ensure the physical implant is strong enough and fits correctly.

It does not contain information relevant to AI/diagnostic device evaluation, such as:

• A table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set of diagnostic images.
• Data provenance for diagnostic images.
• Number of experts for ground truth of diagnostic images or their qualifications.
• Adjudication methods for diagnostic ground truth.
• MRMC studies to show human reader improvement with AI.
• Standalone performance of an algorithm.
• Type of ground truth (e.g., pathology, outcomes data) for diagnostic purposes.
• Training set sample size for an AI model.
• How ground truth for a training set was established for an AI model.

In summary, this document is about a physical orthopedic implant, not an AI or diagnostic software. Therefore, it does not contain the information you are requesting about AI device evaluation methods.

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The Life Spine Metatarsal Hemi Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone with the following clinical conditions: hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) ioint. The device is a single use implant intended to be used with bone cement.

The Life Spine Metatarsal Hemi Implant is an implant that has a tapered stem and a rounded head. The tapered stem allows for the implant to be fixated into the 1st metatarsal. The rounded head resurfaces the metatarsal head in the metatarso-phalangeal joint.

I apologize, but the provided text is a 510(k) premarket notification for a medical device (Life Spine Metatarsal Hemi Implant) and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested for aspects like sample size, ground truth, or expert qualifications for performance evaluation.

The document states that Finite Element Analysis, bench testing (static and dynamic), and engineering rationale were presented to demonstrate substantial equivalence to predicate devices, but it does not detail the specific acceptance criteria for these tests, nor does it present the results of these tests in a tabular format as performance data.

Therefore, I cannot provide the information requested in your numbered list based on the input text. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on a detailed clinical performance study with defined acceptance criteria and study parameters.

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Hemi-Arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® incorporates an articular resurfacing component and a cancellous taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant.

The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.

This document pertains to the 510(k) premarket notification for the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System. It describes a medical device, specifically a hemi-arthroplasty implant for the metatarsophalangeal joint. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way this request is framed. This document, being an FDA 510(k) clearance letter, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria as might be expected for an AI/software device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes:

• Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty System
• Intended Use: Hemi-Arthroplasty implant for the metatarsophalangeal joint for treatment of degenerative and post-traumatic arthritis in the metatarsal joint with good bone stock, hallux valgus or hallux rigidus, and unstable/painful MTP joint.
• Device Description: Incorporates an articular resurfacing component and a cancellous taper post fixation component that mate via a taper interlock. The modification includes modified phalangeal base (concave) implants and a corresponding taper post.
• Substantial Equivalence: The device is considered substantially equivalent to previously cleared predicate devices based on having the same Indications for Use, operating principle, manufacturing materials, shelf life, packaging, and sterilization processes.
• Non-clinical Tests: Comparative Engineering Analyses and Comparative Mechanical Testing (Assembly and Disassembly Testing, Resistance to Torsion Testing, Cyclic Fatigue Testing, Fretting Corrosion Testing, Pull-out Strength Testing, Finite Element Analysis) were performed to demonstrate safety, effectiveness, and substantial equivalence.

Without a detailed clinical or performance study report, or specific quantifiable acceptance criteria for a software/AI device, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement.

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