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The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.

The provided text is an FDA 510(k) clearance letter for the Ascension Silicone MCP and Ascension Silicone PIP devices. This document focuses on the regulatory clearance of a physical medical device (finger joint prostheses) based on a special 510(k) for adding "MR Safe" labeling.

The information you've requested (acceptance criteria and study details for an AI/software device) is not present in this document. The document explicitly states:

• "Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices."
• The determination of "MR Safe" was established through a "scientific rationale that addressed information about the electrical conductivity and magnetic properties of the device material per the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'"

Therefore, I cannot provide the requested details because the device in question is not an AI/software medical device that underwent the type of performance study you're asking about.

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The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:

• Osteoarthrosis;
• Rheumatoid arthritis;
• Post traumatic arthritis.
  The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
• Rheumatoid arthritis;
• Osteoarthritis;
• Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
• Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
• Destroyed articular surface(s).

The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.

This FDA 510(k) summary does not contain the information required to populate the table and answer the study-related questions. Specifically, it discusses mechanical performance testing of the device itself (BRM Digitalis Spacer) but not a clinical study evaluating the device's performance against pre-defined acceptance criteria.

The summary references:

• Mechanical testing: "Mechanical testing included evaluation of static strength of the silicone material as well as fatigue strength testing of the worst-case construct." and "Fatigue testing performed on the subject device... was performed according to ASTM F1781 (2021). Additionally, crack propagation was specifically analyzed as well as wear particle analysis."
• LAL testing: "Additionally, the Digitalis Spacer is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing."

These are tests to ensure the physical properties and safety of the implant, not its clinical effectiveness in patients. An "acceptance criteria" table and details about a "study that proves the device meets the acceptance criteria" would typically refer to a clinical study (e.g., comparing outcomes like pain reduction, range of motion, revision rates) and the statistical methods used to demonstrate non-inferiority or superiority to existing treatments/devices, or to show a certain level of performance against a pre-defined threshold.

Therefore, I cannot extract the requested information from the provided document. The document describes non-clinical performance data for the device's material and mechanical integrity, not clinical performance or acceptance criteria related to patient outcomes.

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The KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative or traumatic arthritis.

The KeriFlex® Finger Joint Prostheses are flexible, one-piece, hinged silicone elastomer implants designed to be implanted across the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed.

The KeriFlex® Finger Joint Prostheses are single-use devices indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative, or traumatic arthritis. The KeriFlex® Finger Prostheses are provided sterile and are intended to be single use.

The associated instruments include:

• Patterns to be used prior to the bone cut to identify the resection level and to identify the definitive implant.
• Starter (awl) to help the surgeon prepare the implantation site.
• Rasps to help the surgeon prepare the implantation site.
• Sterilization tray, lid, insert and rack which protect the instruments during transportation and sterilization.

The provided text is a 510(k) summary for the KeriFlex® MCP and PIP Finger Joint Prostheses. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance.

The document states:

• The device is a physical medical implant (finger joint prostheses).
• The performance data listed (Fatigue Test, Material Characterization, Range of Motion) are typical engineering and biomechanical tests for an implant, not studies on AI/algorithm performance or reader improvement with AI assistance.
• The submission aims to demonstrate substantial equivalence to predicate devices, focusing on similar technological characteristics, materials, and intended use, not on diagnostic accuracy or AI-driven improvements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets acceptance criteria for an AI/algorithm. The information is not present in the provided text.

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The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.

The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.

The one-piece device consists of a specifically designed, central, flexible hinge attached to an elongated rectangular-based pyramid stem on either side. The stems insert into the intramedullary canals of the metacarpals and/or phalanges and have a slight surface texture.

The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements.

The OSTEOTEC Silicone Finger Implant is not designed for use with any other devices. The implant has dedicated instrumentation which is required to prepare the bone for the implant and sizers to ensure that the correct size of product is used.

This document describes the Osteotec Silicone Finger Implant, a joint replacement implant. However, the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other statistical measures often associated with AI/ML medical devices.

The document is a 510(k) premarket notification for a medical device and focuses on establishing substantial equivalence to legally marketed predicate devices, primarily based on material, design, and intended use. The testing discussed ("dynamic mechanical properties," "static mechanical properties," "drop testing," "shelf life," and "instrument tray validation") pertains to the physical and functional characteristics of the implant and its packaging, not to the performance of an AI/ML system.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and a study proving device performance as described in your prompt, because this information is not present in the provided text.

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The Modified DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

The Modified DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant designed to be implanted across the PIP joint. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. This angle is the most obvious difference between the Modified DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.

The provided text is a 510(k) summary for a medical device (DePuy NeuFlex PIP Finger Prosthesis). It describes the device, its indications for use, and its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions requested based on the given input. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.

This 510(k) summary (K082231) describes a medical device rather than a software algorithm or AI. Therefore, the concepts of "acceptance criteria," "study," "test set," "ground truth," "MRMC," and "standalone performance" as they relate to software performance evaluation are not applicable in this context.

The document discusses the Ascension® Silicone PIP, a finger joint prosthesis. For such devices, the "acceptance criteria" and "study" typically refer to bench testing, material characterization, biocompatibility testing, mechanical performance testing, and comparison to legally marketed predicate devices to demonstrate substantial equivalence.

Here's how the provided information relates to the typical evaluation of a medical device like this:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of specific numerical acceptance criteria (e.g., accuracy thresholds) and reported device performance metrics in the way one would for a software algorithm. Instead, the "acceptance criteria" for a physical medical device are inherently met through the demonstration of substantial equivalence to predicate devices and adherence to relevant standards.

The "reported device performance" is inferred from its similarity to the predicate devices and the physical characteristics described.

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

This is irrelevant for a physical medical device. There isn't a "test set" of data in the sense of patient images or clinical records for an AI algorithm. The "test" for a physical device involves various forms of engineering and biocompatibility evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This is irrelevant for a physical medical device. "Ground truth" for a device like this would involve:

• Material specifications: Established by material science experts and standards organizations.
• Design specifications: Established by biomedical engineers.
• Clinical effectiveness (long-term): Established by clinical trials and post-market surveillance (not part of initial 510k for substantial equivalence).

4. Adjudication Method for the Test Set:

This is irrelevant for a physical medical device.

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

This is irrelevant. MRMC studies are used to evaluate the diagnostic accuracy of imaging systems or AI algorithms with multiple readers and cases. The Ascension® Silicone PIP is a prosthetic implant, not a diagnostic tool.

6. If a Standalone Performance Study was Done:

This concept doesn't directly apply. The "standalone performance" of a physical device refers to its ability to perform its intended function (e.g., the flexibility and articulation of the joint, material durability). This is typically assessed through bench testing (mechanical, wear, fatigue) and biocompatibility testing, rather than a "standalone study" akin to an algorithm. The 510(k) summary implies that these tests were conducted or that the shared characteristics with predicate devices negate the need for novel extensive testing for this specific submission.

7. The Type of Ground Truth Used:

For a physical medical device submitted via a 510(k), the "ground truth" for substantial equivalence is primarily based on:

• Predicate Device Data: Evidence that the new device is as safe and effective as a legally marketed predicate device. This includes comparing materials, design, intended use, and performance characteristics.
• Engineering Standards: Compliance with recognized national and international consensus standards for medical device design, manufacturing, and materials.
• Biocompatibility Standards: Evidence that the materials used are safe for implantation in the human body.

8. Sample Size for the Training Set:

This is irrelevant for a physical medical device. There is no "training set" in the context of an AI algorithm.

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

This is irrelevant for a physical medical device.

In summary, the provided 510(k) document is for a medical device (a joint prosthesis) and not a software algorithm. Therefore, the questions posed, which are designed for evaluating AI/software performance, are not directly applicable.

The "study that proves the device meets the acceptance criteria" for a physical device in a 510(k) submission generally refers to:

• Non-clinical testing: Benchtop mechanical testing (fatigue, wear, tensile strength, etc.), material characterization, and biocompatibility testing.
• Comparison to predicate devices: Demonstrating that the new device is substantially equivalent in terms of materials, design, intended use, and performance to one or more legally marketed predicate devices.

The document states: "A comparison of the Ascension Silicone PIP and the DePuy NeuFlex PIP Finger Implant (K001922) and Ascension Silicone MCP (K022892) show similar material, design features, surgical technique and indications." This statement is the core of the "study" described, demonstrating substantial equivalence rather than presenting specific performance metrics from a clinical trial or algorithm test.

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The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.

The Ascension Silicone MCP is an anatomically designed, single-use, one-component hinged prosthesis designed to be implanted without hone cement across the metacarpophalangeal joint. It is made from flexible, injection-molded, medical grade silicone elastomer. The proximal and distal stems of the Ascension Silicone MCP are pre-flexed at 30° to match the approximate natural 30° flexion stance of the relaxed human hand.

The provided text is a 510(k) summary for the Ascension® Silicone MCP finger joint implant. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document explicitly states: "Performance tests and analyses demonstrate that the Ascension® Silicone MCP is substantially equivalent to the predicate device." This indicates that some form of performance assessment was conducted, but the details of these tests, specific acceptance criteria, or the results are not included in this summary.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The information required to answer these questions (acceptance criteria, reported performance, study details, etc.) is not present in the given 510(k) summary.

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Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.

The provided text describes a 510(k) premarket notification for the Avanta Orthopaedics Finger Joint Prosthesis, which aims to demonstrate substantial equivalence to a predicate device, the Sutter Finger Joint Prosthesis. The information is primarily focused on comparing the new device to the predicate device in terms of design characteristics, materials, and indications for use.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a comparison of key characteristics and a specific test.

Study Details

The provided text describes the basis for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive de novo clinical study with detailed performance metrics against quantitative acceptance criteria.

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

   • Sample Size: Not specified. The document mentions "Flexion testing was performed on the Avanta Product" but provides no details on the number of samples tested or the methodology.
   • Data Provenance: Not specified. It cannot be determined if the data is retrospective or prospective, or the country of origin.

2. 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 specified. The study described is a bench test ("Flexion testing") for demonstrating mechanical equivalence, not a clinical trial requiring expert ground truth for diagnostic accuracy.

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

   • Not applicable. This is not a study involving human interpretation or clinical outcomes requiring adjudication.

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

   • No. This is not a study involving AI assistance or human readers.

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

   • No. This is not an algorithm or AI device. The "Flexion testing" could be considered a form of standalone mechanical performance assessment, but not in the context of an algorithm.

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

   • Not explicitly stated in terms of "ground truth" for a diagnostic or clinical outcome. The "ground truth" for the flexion testing would likely be the objective measurements of the device's mechanical properties and its comparison to the predicate device's known mechanical properties or performance standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would have a training set.

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

   • Not applicable. See above.

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The DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

The DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant designed to be implanted across the PIP joint. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. This angle is the most obvious difference between the DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.

The provided text describes a 510(k) summary for the DePuy NeuFlex PIP Finger Prosthesis. It discusses the device's information, indications for use, and substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document only states: "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards." This suggests that the device's performance was compared to existing standards, but the specific details of those standards or any performance data are not included.

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The DePuy DuPont Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

The DePuy DuPont Orthopaedics (DDO) Finger Joint Prosthesis is a flexible, one-piece, hinged silicone elastomer implant designed to be implanted across the metacarpophalangeal (MCP) joint. The proximal and distal stems of the prosthesis form a 30° angle which mimics the approximate position of the joint when the hand is relaxed.

This document (K970544) describes a 510(k) premarket notification for the DePuy DuPont Orthopaedics Finger Joint Prosthesis, which is a flexible, one-piece, hinged silicone elastomer implant. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to meet specific acceptance criteria for performance. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in the context of this document.

Here's the information as it can be extracted from the provided text:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

The document does not detail specific acceptance criteria or report device performance against such criteria in the way a clinical study would. Instead, it relies on demonstrating substantial equivalence to pre-existing devices. The "performance" mentioned is comparative, focusing on flexural fatigue testing.

Basis of Substantial Equivalence (instead of acceptance criteria):

The DDO Finger Joint Prosthesis is considered substantially equivalent to the Dow Corning Wright Swanson Finger Joint Implant and the Sutter Avanta MCP Joint Prosthesis based on:

• Intended Use: All are intended to replace the MCP joint due to rheumatoid, degenerative, or traumatic arthritis.
• Material: All are manufactured from silicone elastomer.
• Design: All have a hinge design.
• Flexural Fatigue Testing: "Flexural fatigue testing shows that the DDO Finger Joint implants sustain the same or less damage than the Swanson or Sutter implants when cycled through a total of 90° of flexion/extension for 10 million cycles."

1. A table of acceptance criteria and the reported device performance
As noted above, this document focuses on demonstrating substantial equivalence, not on meeting specific quantitative acceptance criteria of the type that would typically be reported in a table for device performance against predefined thresholds in a clinical study. The performance described is in comparison to predicate devices, specifically:

This implicitly suggests that "sustaining the same or less damage" than the predicate devices under these conditions serves as an acceptable "performance."

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. The document mentions "Flexural fatigue testing" but does not detail the sample size (number of implants tested), the specific test set used, or any human-subject data. This appears to be bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study involving human-subject data or medical diagnosis where expert ground truth would be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving adjudication of clinical cases or 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 not a study involving AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the flexural fatigue testing would be the physical measurement of damage or failure based on engineering standards, not medical ground truth.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the ground truth for the training set was established
Not applicable. See above.

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