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The BRM Extremities NewPrim device is intended for use in:

• Hallux rigidus or hallux limitus;
• Painful rheumatoid arthritis;
• Hallux abducto valgus associated with arthritis;
• Unstable or painful joint from previous surgery

The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The provided text is a 510(k) summary for the BRM Extremities NewPrim System, a toe joint polymer constrained prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.

The document does not contain information about a clinical study with acceptance criteria, human readers, or ground truth for evaluating the device's performance in the context of diagnostic accuracy or clinical outcomes. Instead, it describes bench testing conducted to support substantial equivalence.

Therefore, many of your requested points cannot be answered based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document mentions two types of bench testing:

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: Not specified for any of the bench tests.
• Data Provenance: This is bench testing, not clinical data from patients. The manufacturer is BRM Extremities, located in Milano, Italy.

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

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

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

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

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 device is a prosthesis, not an AI diagnostic tool.

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

Not applicable. This device is a prosthesis, not an AI diagnostic tool.

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

For the bench tests, the "ground truth" would be the predefined engineering specifications and comparison to the predicate device's measured performance for mechanical characteristics and compliance with a standard for LAL testing. It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.
The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for the Fusion Silastic System, a toe joint prosthesis. It outlines the company's claim of substantial equivalence to predicate devices.

Based on the provided document, there is NO information about acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document is for a physical medical device (toe joint prosthesis) and does not describe any AI component or a study to evaluate AI performance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

• Non-clinical Test Summary: "Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational was performed to show performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."
• Clinical Test Summary: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria because the provided text describes a physical implant and its regulatory clearance process, not an AI-powered device.

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The RTS® Lesser MTP Implant is intended for use in the treatment of:

• · Partial or complete dislocation of the lesser metatarsophalangeal joint
• · Pain associated with either rheumatoid or osteoarthritis
• · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
• · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.

The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials

This document is a 510(k) premarket notification for the RTS® Lesser MTP Implant System, which is a medical device. As such, the information provided does not include the detailed acceptance criteria and study data typically associated with software or AI device performance. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/software device would.

However, I can extract the information related to performance testing that was conducted to support the substantial equivalence claim for this physical implant.

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

Since this is a physical implant and not a software/AI device, the "acceptance criteria" are not reported in terms of metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs equivalently to the predicate devices in terms of its physical and material properties and its ability to withstand standard sterilization, cleaning, and packaging processes.

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

The document does not specify a "test set" in the context of human subjects or patient data. The performance testing refers to bench and in-vitro tests for cleaning, packaging, sterilization, and engineering analysis (Finite Element Analysis). Therefore, information on sample size, country of origin, or retrospective/prospective nature is not applicable in the way it would be for a clinical AI study.

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. Ground truth for clinical outcomes in a human study is not established here. The "ground truth" for the engineering performance and material properties would be established by standard engineering and material science methodologies, not by expert medical consensus in the way an AI diagnostic device would.

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

Not applicable, as there is no human "test set" or clinical adjudication process 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 is not an AI device, and no MRMC study was conducted.

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

Not applicable. This is a physical implant, not an algorithm.

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

For the performance testing mentioned (cleaning, packaging, sterilization, engineering analysis), the "ground truth" would be established by:

• Validated laboratory protocols and standards: For cleaning, packaging, and sterilization.
• Engineering principles and material science data: For Finite Element Analysis, comparing results against established material properties and design specifications.
• Predicate device characteristics: The fundamental "ground truth" for substantial equivalence is the existing legally marketed predicate device, whose safety and effectiveness have already been established.

8. The sample size for the training set

Not applicable. This is a physical implant, not an AI model, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

Summary of Device Performance (from the document):

The document states: "The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." This overarching statement serves as the conclusion for meeting "acceptance criteria" in a 510(k) context. The specific tests performed were:

• Validations for cleaning of implants and surgical instruments.
• Validations for packaging of implants and surgical instruments.
• Validations for sterilization of implants and surgical instruments.
• Engineering analysis, including Finite Element Analysis.

The device is concluded to be substantially equivalent to the predicate devices (OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System and Integra Lesser Metatarsal Phalangeal Implant) based on similar indications, materials (Medical Grade Silicone Elastomer), and geometry.

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The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:

• Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• Unstable or painful joint from previous surgery

The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

This document is a 510(k) premarket notification for a medical device called the "RTS Flexible 1st MPJ Implant w/Grommets." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically understood for a new clinical efficacy study, is largely not applicable in this context.

Here's why and what information can be extracted based on the document:

• No specific acceptance criteria or performance metrics are provided in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. This device is a surgical implant, not a diagnostic AI device. The "performance data" referred to are related to engineering, cleaning, packaging, and sterilization validation, not clinical performance metrics.
• No "study" as a clinical trial comparing device performance to acceptance criteria in the manner of an AI/diagnostic device is presented. The "study" here is essentially the demonstration of substantial equivalence.

However, I can extract the relevant information that is present in the document based on your request, highlighting where the requested details are not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a 510(k) submission for a surgical implant, not a study involving a "test set" of data for algorithm performance. The "performance data" mentioned refers to engineering and validation testing (e.g., cleaning, packaging, sterilization), not clinical outcome data or diagnostic performance data. Therefore, there's no "sample size" or "data provenance" in the context of an AI/diagnostic algorithm test set.

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

• Not Applicable. As above, no "test set" for expert-derived ground truth is described in this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No test set or related adjudication method is mentioned.

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

• Not Applicable. This is a surgical implant, not a diagnostic AI device. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are not relevant to this submission.

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

• Not Applicable. This is a surgical implant. There is no algorithm or AI component involved.

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

• Not Applicable. The "ground truth" in this context is the predicate device and its established safety and effectiveness. The current device aims to demonstrate "substantial equivalence" to this predicate, rather than generating new primary ground truth for clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not Applicable. There is no training set or associated ground truth establishment process for a training set in this submission.

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The indications for the OrthoFlex Rod include:

• Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
• Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
• Revision of a failed arthroplasty or arthrodesis

The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.

This OrthoFlex Rod 510(k) summary explicitly states that "No clinical studies were performed" and therefore no acceptance criteria or studies proving device performance against such criteria are provided in the document.

The submission focuses on establishing substantial equivalence to predicate devices based on intended use, design, material, and function, rather than demonstrating performance through clinical studies and predefined acceptance criteria.

Therefore, the requested tables and information cannot be generated from the given text.

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Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for:

• Partial or complete dislocation of the lesser metatarsophalangeal joint
• Pain Associated with rheumatoid or osteoarthritis
• Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint .
• Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Kohler's disease
• Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

The Lesser Metatarsal Phalangeal Joint Implant is a double-stemmed silicone prosthesis, intended to supplement lesser metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the metatarsal and base of the proximal phalanx.

This document is a 510(k) summary for a medical device called the "Lesser Metatarsal Phalangeal Joint Implant." It's a submission to the FDA (Food and Drug Administration) to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Sutter Lesser Metatarsal Phalangeal Joint Prosthesis."

The regulatory path for this device is based on substantial equivalence, not on meeting specific acceptance criteria derived from a performance study against a predefined standard. Therefore, many of the requested items, such as a table of acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, and study designs (MRMC, standalone), are typically associated with performance-based regulatory clearances or approvals (like de novo classification or PMA applications) rather than 510(k) submissions demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This submission is for a medical device seeking 510(k) clearance based on substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria from a clinical or analytical study. The "acceptance criteria" here implicitly refer to demonstrating equivalence in design, materials, indications for use, and technological characteristics to the predicate device.

  The comparison provided is qualitative, highlighting similarities between the proposed device and the predicate:

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

• Not Applicable. No "test set" in the context of a clinical performance study is described. The submission focuses on comparing the proposed device's characteristics to a predicate device.

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

• Not Applicable. No expert-adjudicated test set is described. The "ground truth" for this 510(k) is the demonstrated similarity to the predicate device's design and intended use, as reviewed by the FDA.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or associated adjudication method is mentioned.

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

• Not Applicable. This is a device for surgical implantation, not an imaging diagnostic device that would typically undergo an MRMC study.

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

• Not Applicable. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used:

• For this 510(k) submission, the "ground truth" for the substantial equivalence determination is the characteristics and performance of the legally marketed predicate device (Sutter Lesser Metatarsal Phalangeal Joint Prosthesis) combined with the design specifications and intended use of the proposed device. The evaluation relies on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate.

8. The Sample Size for the Training Set:

• Not Applicable. No "training set" in the context of an AI/ML algorithm is described.

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

• Not Applicable. No training set is described.

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Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only.

The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.

The provided document is a 510(k) summary and FDA clearance letter for a medical device, the OsteoMed Interphalangeal Flexible Stabilizing Rod System. This type of document is generally used for demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics as might be found for a novel device requiring clinical trials.

Therefore, this document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant." It also notes: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Interphalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues."

This indicates that the clearance was based on substantial equivalence to an already legally marketed device, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria as would be required for a device for which no predicate exists or for a higher-risk classification device. The FDA letter confirms the substantial equivalence determination.

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Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.

The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any acceptance criteria. The document is a 510(k) summary for a medical device called the "OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System." It primarily focuses on demonstrating substantial equivalence to a predicate device (Sgarlato Lesser Toe Implant K884739) based on similarities in intended use, material, design, and operational principle.

The document does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically associated with performance studies, especially those involving AI/ML devices or novel devices requiring more extensive clinical evidence. The provided document is a regulatory submission for a device deemed substantially equivalent to a predicate, which often does not require new performance studies if the safety and effectiveness are established through the predicate.

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Futura Biomedical Classic Great Toe Implant is indicated for:

• Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• Unstable or painful joint from previous surgery

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Futura Biomedical Classic Great Toe Implant:

Observation: The provided text is a 510(k) summary for a medical device (toe implant). It describes the device, its intended use, and argues for its substantial equivalence to a previously marketed device. Crucially, it does not contain information about acceptance criteria or a study proving device performance against such criteria. It's a regulatory submission focused on demonstrating equivalence and safety, not on a performance study with specific metrics and acceptance thresholds.

Therefore, the following points cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance results.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a performance study.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the text focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be inferred or stated based on the provided document:

Summary of Device and Regulatory Context (Based on the provided text):

The document is a 510(k) Pre-market Notification for the Futura Biomedical Classic Great Toe Implant, specifically introducing a new, larger size (size 60) for an existing line of implants. The notification aims to demonstrate substantial equivalence to the original Futura Biomedical Classic Great Toe Implant (K023086).

1. Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or performance study results are reported in this 510(k) submission. The submission's purpose is to demonstrate substantial equivalence to a predicate device, not to present a new performance study with pass/fail criteria.
• The argument for equivalence is based on the new device (larger size) having similar design characteristics, materials, intended use, and mechanism of action as the predicate device.

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

• Not applicable. This document does not describe a performance study involving a test set of data. It is a regulatory submission for a physical implant.

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

• Not applicable. No such "ground truth" establishment in the context of a performance study is described.

4. Adjudication Method for the Test Set:

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

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

• No. This document does not mention or present an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for physical implants in a 510(k) of this nature.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is a physical toe implant, not an algorithm. Therefore, a standalone performance study in that context is not relevant and not discussed.

7. Type of Ground Truth Used:

• Not applicable. No performance study employing a "ground truth" (expert consensus, pathology, outcomes data) is described in this submission. The "truth" in this context is the comparison of the new device's characteristics against the predicate device.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI algorithm that requires a "training set."

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

• Not applicable. As above, there is no AI algorithm or training set described.

Conclusion from the provided text:

The 510(k) submission for the Classic Great Toe Implant (size 60) does not contain information about acceptance criteria for a performance study or details of such a study. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (the original Classic Great Toe Implant, with sizes 20, 30, 40, 50). This equivalence is reasoned based on identical intended use, materials, basic design principles (double-stemmed silicone prosthesis, constrained, intramedullary canal fixation), and manufacturing processes. The only difference highlighted is the addition of a new, larger size (size 60) to the existing product line.

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Futura Biomedical Classic Great Toe Implant is indicated for:

• Hallux limitus or hallux rigidus .
• . Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis ●
• Unstable or painful joint from previous surgery .

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The provided text is a 510(k) summary for a medical device called the "Classic Great Toe Implant." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain any information regarding clinical studies, performance data, acceptance criteria, or ground truth establishment.

The document explicitly states that the device is substantially equivalent to a predicate device based on design characteristics and intended use, rather than clinical performance data from studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence, not performance evaluation through studies.

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