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The Eclipse Total Ankle replacement system is intended for prosthetic replacement of the tibio-talar joint in patients affected with severe rheumatoid, post-traumatic, or degenerative arthritis. It is also intended for revision of prior ankle surgery, and is intended for use with bone cement.

The Eclipse Total Ankle implant is intended for use in total ankle joint replacement arthroplasty. The system consists of various size range components to accommodate variations in human ankle anatomy. Materials: -Cobalt Chrome, per ASTM F75, with Titanium Plasma Spray Coating per ASTM 1580 (Tibia Plates / Talar components) -U.H.M.W.Pe., per ASTM 648-00 (Bearing) -Titanium Alloy per ASTM F-136 (Bone screws) Function: The Eclipse Total Ankle system functions as a replacement for the ankle joint.

This document is a 510(k) premarket notification for the Eclipse Total Ankle Implant, a medical device for ankle joint replacement. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device, demonstrating its substantial equivalence to previously marketed devices.

Based on the provided text, there is no study described that establishes acceptance criteria or reports device performance against such criteria in the way typically expected for an AI/CADe device. This document is for a physical orthopedic implant seeking FDA clearance as a Class II device. The information provided focuses on demonstrating substantial equivalence to a predicate device (DePuy Agility Total Ankle Orthopedic Implant).

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI/CADe device. However, I can extract the general information pertinent to this 510(k) submission:

Interpretation for a traditional medical device (not AI/CADe):

In the context of traditional medical devices like the Eclipse Total Ankle Implant, "acceptance criteria" are not reported as specific performance metrics (like sensitivity, specificity) against a ground truth as they would be for an AI algorithm. Instead, acceptance criteria are generally met by demonstrating:

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing similar indications for use, technological characteristics (materials, basic mechanical features), and safety and effectiveness.
• Compliance with Standards: The materials used (Cobalt Chrome, U.H.M.W.Pe., Titanium Alloy) are specified to meet ASTM standards, which are a form of acceptance criteria for material properties.
• Intended Use and Contraindications: The clear definition of intended use and contraindications is part of establishing the device's safe application.

The "study" or justification for meeting these "acceptance criteria" is the 510(k) submission itself, which argues for substantial equivalence.

Specific answers based on the provided text, re-interpreting the questions for a physical implant:

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

   • Acceptance Criteria (implicit for 510(k) of a physical implant):
     • Substantial Equivalence to legal predicate device.
     • Use of materials compliant with recognized standards (e.g., ASTM F75, ASTM 1580, ASTM 648-00, ASTM F-136).
     • Similar indications for use, technological characteristics, and safety/effectiveness profile as the predicate.
   • Reported Device Performance: The document states, "There are no significant differences between the Eclipse Total Ankle Implant and other total ankle joint replacement systems currently being marketed which would adverselv affect the use of the product. The Eclipse Total Ankle Implant employs the same materials and basic mechanical features as the predicate, legally marketed device specified in section 3 (DePuy Agility total ankle arthroplasty system)." This statement is the "reported device performance" in the context of a 510(k) for substantial equivalence – meaning its performance is considered equivalent to the predicate. No specific performance data (e.g., durability, range of motion in patients) is provided in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/CADe device being tested on image data. The "test set" would implicitly refer to the device itself and its components as compared to the predicate. The document doesn't detail a clinical study with a patient sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would generally relate to clinical outcomes, which are not detailed in this 510(k) summary. The "ground truth" for substantial equivalence is regulatory comparison.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication is described. The "adjudication" is essentially the FDA's review of the substantial equivalence claim.

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/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/CADe device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a traditional orthopedic implant's 510(k), the "ground truth" for demonstrating safety and effectiveness implicitly relies on:

   • Predicate Device History: The established safety and effectiveness of the predicate device (DePuy Agility Total Ankle Orthopedic Implant).
   • Material Standards: Compliance with recognized ASTM material standards.
   • Design Principles: Sound biomechanical and engineering principles, assumed to be similar to the predicate.
     No specific pathology or outcomes data from a prospective study for this specific device is presented in this document for clearance.

8. The sample size for the training set: Not applicable. This is not an AI/CADe device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/CADe device.

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The KMI Cement Restrictor Implant is intended to be implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug. The safety and effectiveness of this device for use in the spine have not been established.

The KMI Cement Restrictor Implant is a flexible, bio-resorbable restrictor designed to provide a quick and effective method of plugging the intramedullary canal with an easy-to-place absorbable bone plug. Based on the size of the canal and reamer used to form the channel, the appropriate size cement restrictor is selected and is guided into the canal to the desired depth. The KMI Cement Restrictors are malleable to take on the irregular shape of the canal, effectively sealing them at the desired friction-fit position. There are a variety of sizes and shapes offered, including cylindrical and cube versions. Each device can be custom shaped either by manual manipulation, by using a scalpel at the time of surgery, or by press-fitting into the canal.

This prompt describes a 510(k) premarket notification for a medical device and not a study that proves the device meets specific acceptance criteria via performance data. Therefore, many of the requested fields cannot be filled as they pertain to clinical trial design and results.

However, I can extract the information relevant to the device and its intended use, as well as the FDA's acceptance of its substantial equivalence.

Here's a breakdown of the provided information, noting what can (and cannot) be answered based on the input:

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

This document does not provide a table of acceptance criteria or reported device performance for the KMI Cement Restrictor. It is a 510(k) summary, which demonstrates substantial equivalence to a predicate device rather than providing performance data against predefined criteria. The FDA's letter states they have "reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent." This implies the device met the regulatory requirements for showing substantial equivalence, which is the "acceptance criteria" in this context, but no specific performance data is provided in the document.

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. This is a 510(k) submission, not a study report with a test set of data. Substantial equivalence is typically demonstrated through comparison of design, materials, and intended use to a predicate device, sometimes supported by non-clinical testing (e.g., biocompatibility, mechanical testing) but not necessarily a "test set" of clinical data for performance metrics.

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. No ground truth establishment for a test set is described in this 510(k) summary.

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

Not applicable. No test set or adjudication method is described.

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 pertains to a cement restrictor, not an AI or imaging device that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No ground truth is described in the context of device performance testing. The "ground truth" for a 510(k) itself is the existing legal market status and safety/effectiveness profile of the predicate device.

8. The sample size for the training set

Not applicable. This is not a study involving a training set.

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

Not applicable. No training set is described.

Summary of Device Information (from the provided text):

• Device Name: KMI Cement Restrictor
• Common Name: Bone Plug
• Classification Name: Cement Obturator
• Product Code: LZN (initially), later determined to be JDK (Surgical mesh) by FDA.
• Submitter: Kinetikos Medical, Inc.
• Predicate Device: Improve Absorabale Cement Flow Restrictor (K011943)
• Description: Flexible, bio-resorbable restrictor designed to plug the intramedullary canal as an absorbable bone plug. Malleable, can be custom shaped.
• Materials: L,D-L Lactic Acid Polymer
• Shelf Life: Two (2) years
• Intended Use: Implanted inside the intramedullary canal for use as an absorbable bone cement flow restrictor plug.
• Contraindications: Active local infection, allergic reaction to foreign bodies, poor/insufficient bone stock, clinical/functional abnormalities precluding good results, other patient risks, and spinal applications.

Key FDA Determination/Acceptance:

• Determination: The device is "substantially equivalent" to legally marketed predicate devices.
• Limitations/Warnings:
  • "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS."
  • "WARNING: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
  • These warnings must be prominently displayed in all labeling and promotional materials.

In conclusion, this document serves as a regulatory approval notice based on substantial equivalence to a predicate device, not a performance study detailing acceptance criteria and their fulfillment through specific test results.

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The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.

The MBAResorb Implant consists of a soft-threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The design differs from the predicate Subtalar MBA device only in that the material is reabsorbed into the body.

This document describes a 510(k) premarket notification for a medical device called the MBAResorb Implant. It is not a study proving the device meets acceptance criteria. The document is an application to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text. These elements are typically found in clinical study reports or detailed performance data submissions, which are not present here.

Summary of what can be extracted related to the device and its intended use:

• Device Name: MBAResorb Implant
• Intended Use: "The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing."
• Material: Poly L-Lactide (PLLA), described as bioresorbable.
• Predicate Device: KMI Subtalar MBA Orthopedic Foot Implant (K960692), cleared Jul 23, 1996.
• Regulatory Clearance: The FDA letter (SEP - 6 2005) indicates that the device was deemed substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This is a regulatory clearance, not a performance study outcome.

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The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.

Materials: Titanium; Ti-6A14V-ELI as per ASTM F136

Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.

This document describes a 510(k) premarket notification for a medical device and, as such, does not typically contain information about comprehensive clinical studies with detailed acceptance criteria and reported device performance metrics in the way a PMA (Premarket Approval) application or a clinical trial report would.

The provided text focuses on establishing substantial equivalence to a predicate device, which is the cornerstone of the 510(k) pathway. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not part of this type of submission.

However, I can extract the relevant information and explicitly state where information is not provided in the document.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance (Not applicable for this type of submission)

The provided document is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than demonstrating "acceptance criteria" and "reported device performance" through a novel clinical study with hard performance metrics. The "acceptance criteria" in this context are implicitly met by demonstrating technological characteristics and intended use that are substantially equivalent to a legally marketed predicate device.

Table 1: Acceptance Criteria and Reported Device Performance (N/A for 510(k) Summary)

Study Details (Information largely not provided in this 510(k) summary)

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 applicable. This 510(k) submission does not describe a clinical study with a "test set" of patient data for performance evaluation in the way a clinical trial would. It relies on a comparison of technological characteristics to a predicate device.
   • Data Provenance: Not applicable. No clinical data is presented.

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. No clinical study with a "test set" requiring expert-established ground truth is described.

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

   • Not applicable. No clinical study requiring adjudication of a "test set" is described.

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 device is a metallic bone fixation appliance, not an AI software/diagnostic device, and thus an MRMC study is not relevant to its regulatory pathway.

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

   • Not applicable. This device is a physical implant, not an algorithm, so standalone performance in this context is not relevant.

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

   • Not applicable as no clinical study for performance evaluation is described. The "ground truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are fundamentally similar to a previously cleared device.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable. No "training set" or establishment of ground truth for such a set is relevant to this submission.

Summary of what the document does provide regarding "proof" and "acceptance criteria":

• Substantial Equivalence Pathway: The entire submission serves as proof that the device is "substantially equivalent" to a legally marketed predicate device (Hand Innovations Distal Volar Radius Fracture Repair System, K002775).
• Technological Characteristics Comparison: The document states that there are "no significant differences between the KMI Distal Volar Radius Plate and other systems currently being marketed which would adversely affect the use of the product." It explicitly mentions the use of "the same basic mechanical features as the predicate."
• Material Equivalence: The material (Titanium; Ti-6A14V-ELI as per ASTM F136) is specified, implying it's a known, safe, and effective material for this application, likely consistent with the predicate.
• Intended Use Equivalence: The "Indications for Use" of the KMI Distal Volar Radius Plate are aligned with the general use of similar devices for distal radius fracture fixation, indicating it serves the same clinical purpose as the predicate.
• Regulatory Acceptance: The letter from the FDA (AUG 16 2004) explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This FDA determination serves as the "acceptance" that the device meets the substantial equivalence criteria.

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The KMI Katalyst Radial Head Implant is generally indicated for radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

The KMI Katalyst Radial Head implant is intended for use in radial head replacement arthroplasty. The system consists of modular stem and head components to accommodate variations in human anatomy. The design incorporates an adjustable stem length capability to allow stem length adjustment in-sito.
Materials: -Cobalt Chrome, per ASTM F75 -Stainless Steel BioDur 108 Alloy per ASTM F2229 -UHMWPE per ASTM 648-00
Function: The system functions as a replacement for the proximal radial head.

The provided text is related to a 510(k) premarket notification for a medical device called the "Katalyst Radial Head Implant." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information about acceptance criteria, study design, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a report of a clinical performance study.

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The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including: Infection, Metal sensitivity or allergic reaction to foreign bodies, Any concomitant disease which may compromise the function of the implant, In those cases where avascular necrosis has rendered bone stock inadequate.

The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and compress bone segments. The implant is available in a variety of sizes to accommodate various fracture types and sites. Materials: Titanium; Ti-6A14V-ELI per ASTM F136. The system functions to draw bone fractures together, thereby facilitating fixation.

The provided text is a 510(k) premarket notification for the KMI Kompressor Compression Screw System. This document focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many of the requested details about acceptance criteria, study design, sample size, expert involvement, and ground truth are not available in the provided text.

Here's an attempt to answer the questions based on the available information, with clear indications where the information is not present:

Acceptance Criteria and Device Performance Study for the KMI Kompressor Compression Screw System (K040356)

The provided submission does not contain a study report with specific acceptance criteria and reported device performance as would be found in a clinical trial or performance study for a novel device. Instead, this 510(k) relies on demonstrating "substantial equivalence" to a legally marketed predicate device (KMI Kompressor compression screw, K024233).

The "acceptance criteria" in this context are implicitly the requirements for substantial equivalence, meaning the modified device should not raise new questions of safety or effectiveness and performs similarly to the predicate. The "reported device performance" is essentially that its mechanical features and intended use align with the predicate, with changes limited to size ranges and broadened indications.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable / Not provided. This submission does not detail a test set from a performance study. It relies on a comparison to a predicate device.
• Data Provenance: Not applicable / Not provided.

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 submission focuses on comparing the new device's design to an existing, cleared device, not on evaluating its performance against a ground truth established by experts.

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

• Not applicable / Not provided.

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 / Not provided. This is a submission for a mechanical implant, not an AI-assisted diagnostic device.

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

• Not applicable / Not provided. This is a submission for a mechanical implant.

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

• Not applicable. The "ground truth" for this 510(k) is effectively the regulatory clearance of the predicate device and the accepted scientific and engineering principles for medical implants. No new "ground truth" derived from clinical data or expert consensus for this specific device would typically be required for a substantial equivalence determination under 510(k), especially given the minor modifications.

8. The sample size for the training set

• Not applicable / Not provided. This is a submission for a mechanical implant, not a machine learning algorithm.

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

• Not applicable / Not provided.

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The use of the Kompressor compresion screw is generally indicated for the reduction and fixation of fractures of the small bones of the hand and wrist, such as the scaphoid. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed.

Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fıx fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.

Materials: Titanium; Ti-6A14V-ELI as per ASTN F136

Function: The system functions to draw bone fractures together, thereby facilitating fixation.

The provided text describes a 510(k) premarket notification for a medical device called the "Kompressor Compression Screw System." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance criteria through a clinical study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment for a study is not present in the provided text. The 510(k) pathway primarily relies on comparing the new device's technological characteristics, materials, and intended use to those of already approved devices.

Here's a breakdown of why the requested information cannot be provided based on the given text:

• Acceptance Criteria and Reported Device Performance: This type of information is typically found in a clinical trial report or a performance study. The 510(k) document (K024233) aims to show that the Kompressor Compression Screw System is substantially equivalent to predicate devices (Milennium Medical Technologies Headless Bone Screw K020791 and Newdeal I.CO.S Ideal Compression Screw K993762), implying it performs similarly to devices already on the market. It does not outline specific, measurable performance criteria to be met and their achievement in a study.
• Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Training Set Ground Truth Establishment: These details are standard components of a detailed clinical or performance study. The provided text is a summary of safety and effectiveness within a 510(k) submission, which does not typically include the intricate design and results of such studies. The document mentions "Comparison of technological characteristics" and highlights that "There are no significant differences...which would adversely affect the use of the product." This comparative approach, rather than a de novo performance study, is the core of a 510(k).

In summary, the provided document (K024233) is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, not de novo performance through a study with explicit acceptance criteria.

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Indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. The Universal Total Wrist is intended for cemented use.

The KMI Universal Total Wrist (UTW) System (both predicate and extra small) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component, and two bone screws. The system will now be offered in 4 (four) sizes: 'extra small', 'small', 'medium' and 'large'), each with 3 (three) matching polymer component sizes, which are available in yarvina thicknesses (height); standard, +1 and + 2, It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW Surgical Protocol.

Here's an analysis of the provided text regarding the Universal Total Wrist System, focusing on acceptance criteria and supporting studies:

Based on the provided documents, this 510(k) submission (K030037) is a Special 510(k) Notification for a modification to an already cleared device, the Universal Total Wrist System. Specifically, it's for introducing an "extra small" size. Special 510(k)s often rely heavily on demonstrating substantial equivalence to a predicate device and may not involve extensive new clinical or performance studies in the same way a novel device might.

Therefore, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the traditional sense (e.g., performance metrics with defined thresholds for a new device) is not directly applicable or explicitly detailed in these documents for the modified device. Instead, the "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate device. The "study" is more accurately described as a comparison and analysis against the predicate.

Here's the breakdown of the information as requested, tailored to the context of a Special 510(k) for a size modification:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Study Details (Comparison for Substantial Equivalence)

1. Sample size used for the test set and the data provenance:

   • Test Set: No clinical test set in the traditional sense is described. The "test set" for this submission consists of the engineering drawings and specifications of the "extra small" implant.
   • Data Provenance: The comparison is based on the design specifications and material properties of the new "extra small" component and the previously cleared "small" (predicate) component. The provenance is internal manufacturing and design data from Kinetikos Medical, Inc. This is a retrospective comparison against an already cleared predicate device.

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

   • No external experts were explicitly mentioned as being used to establish "ground truth" for this engineering comparison. The "ground truth" for the comparison is the design and material specifications of the predicate device, which were previously reviewed and cleared by the FDA. The manufacturer's internal engineering and quality assurance personnel would have performed the comparison.

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

   • No adjudication method in the context of expert review is described. The comparison relies on documented specifications. The FDA's review process itself acts as an adjudication that the presented information supports substantial equivalence.

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 device is a mechanical implant (wrist prosthesis), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers/AI is irrelevant and was not conducted.

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

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

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

   • The "ground truth" for this submission is the already established and FDA-cleared design, material, manufacturing, and performance characteristics of the predicate Universal Total Wrist System. The "extra small" size is demonstrating conformity to these established truths by being "identical" in all key aspects except size.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a learning algorithm. The "training" for the predicate device would have involved a long clinical history of similar materials and designs, as explicitly stated: "It is constructed of materials that have a long clinical history of proven acceptance and performance." This refers to general knowledge about medical-grade materials, not a specific training dataset for this device.

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

   • Not applicable. As above, there's no "training set." The "ground truth" for the overall device's safety and effectiveness (as represented by the predicate) was established through previous FDA clearances based on established standards, material properties, mechanical testing, and clinical history of similar devices.

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The K2 Hemi Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; Hallux valgus, hallux rigidus and an unstable or painful MTP joint.

The KMI Great Toe Implant System consists of 4 (four) sizes of toe implants. The implants will now be plasma coated. It is constructed of materials that have a lona clinical history of proven acceptance and performance. This system is intended for press fit use only and will be promoted as such in the Surgical Protocol 81-0065.

The provided text is a 510(k) premarket notification for a medical device called the "K2 Hemi Great Toe Implant System." This document is focused on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not include information about acceptance criteria or a study proving device performance in the context of AI/ML or software validation.

The document discusses:

• Device Name: K2 Hemi Great Toe Implant System
• Intended Use: Treatment of patients with inflammatory arthritis in the first metatarsal joint with good bone stock and integrity of the first metatarsal head, along with clinical conditions like Hallux valgus, hallux rigidus, and unstable/painful MTP joint.
• System Description: Consists of 4 sizes of toe implants, now plasma coated, made of materials with a long clinical history. Intended for press-fit use.
• Equivalence to Marketed Product: States identical design (except for spike feature elimination), identical operating principle/surgical protocol, and identical packaging/sterilization. The primary difference is the addition of a titanium plasma coating.
• Predicate Devices: Harmos Orthopedic, Inc. Great Toe Implant System (K014164) and Futura Biomedical Hemi Toe implant (K971047).

Since the request asks for information related to acceptance criteria and studies that prove device performance, specifically in the context of AI/ML validation metrics, and the provided text is for a physical orthopedic implant seeking 510(k) clearance based on substantial equivalence, the requested information (points 1-9) cannot be extracted from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but this is a regulatory standard, not a performance metric for AI/ML as implied by the questions.

Therefore, I must state that the provided information does not contain the details necessary to answer the questions about acceptance criteria, study design, sample sizes, expert involvement, or AI/ML performance metrics.

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Indicated for intractable pain resulting from traumatic arthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. Intended for cemented use only.

The KMI Universal Total Wrist™ (UTW) System (either predicate or modification) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component and two bone screws. The system is offered in three sizes (small, medium, and large), with three matching polymer component sizes, which are available in varying thicknesses (standard, +1 mm, +2 mm). It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW surgical technique manual.

The provided text is a 510(k) summary for a medical device (Universal Total Wrist™ System), not a study report detailing acceptance criteria and performance against those criteria. Therefore, I cannot extract the requested information as it is not present in the provided document.

The document focuses on:

• Administrative information: Manufacturer, contact, device names, predicate device.
• Intended use: Medical conditions for which the device is indicated.
• System description: Components, sizes, and materials.
• Equivalence to marketed product: Claims of similarity to a predicate device.
• FDA clearance letter: Confirmation of substantial equivalence.
• Indications for Use statement: Formal statement of approved uses.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, or adjudication methods for ground truth establishment.
• Comparative effectiveness studies (MRMC) or standalone algorithm performance.

The document describes a modification to an existing device, emphasizing its substantial equivalence to the predicate device based on material composition, intended use, operating principle, and basic design, rather than presenting a performance study with detailed acceptance criteria.

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