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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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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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Osteoarthritis. Where the use of a more conservative procedure has failed or is unacceptable. The device is intended for non-cemented use.

The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets them.

The document is a 510(k) summary and an FDA clearance letter for the Signal Medical Corporation Great Toe Implants. It focuses on:

• Device Description: What the device is made of and its general function.
• Intended Use/Indications for Use: What the device is for (osteoarthritis, when conservative procedures fail).
• Substantial Equivalence: The FDA's determination that this device is substantially equivalent to previously marketed predicate devices (Townley Great Toe Joint 510K (K911378) and Zimmer Great Toe 510K (K823405)). This is the core of a 510(k) submission, confirming that a new device is as safe and effective as a legally marketed one without requiring new clinical trials or extensive performance testing if the predicate device itself didn't necessitate them.
• Regulatory Information: FDA regulations, general controls, and contact information.

This type of submission typically relies on comparison to predicate devices, material testing, and sometimes bench testing, rather than extensive clinical studies with specified acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex medical device.

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the given text.

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The 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 Great Toe Implant System is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the base of the proximal phalanx and provide a smooth articular surface for the adjacent metatarsal head. It is available in several sizes to accommodate variations in anatomy. Primary fixation is via a press fit.
Materials: The devices are manufactured from CoCrMo alloy per ASTM and ISO standards,
Function: The system functions to provide pain relief and improved function to the first metatarsal joint that has been damaged by inflammatory arthritis.

The provided text is a 510(k) summary for a medical device (Great Toe Implant System) seeking FDA clearance. It does not contain specific acceptance criteria, a study proving device performance against such criteria, or any of the detailed information requested in the prompt regarding a clinical study or AI performance evaluation.

The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the United States. This process typically involves comparing the new device's design, materials, manufacturing process, and intended use to a legally marketed predicate device, rather than conducting new clinical studies or establishing detailed performance metrics against acceptance criteria for novel technologies.

Therefore, I cannot provide the requested information from the provided text. The document clearly states:

• "There are no significant differences between the Great Toe Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

This indicates that the clearance is based on equivalence, not on the demonstration of specific performance metrics from a new study meeting predefined acceptance criteria.

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Indications for use of this implant are:

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

The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure. This is consistent with the description and intended use of the Swanson Flexible Hinge Toe Implant.

This submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary for a flexible great toe implant, focusing on substantial equivalence to a predicate device and its intended use. The document discusses:

• Device Description and Intended Use: A double-stemmed silicone prosthesis for first metatarsophalangeal joint arthroplasty, acting as a dynamic joint spacer.
• Indications for Use: Hallux limitus/rigidus, painful rheumatoid arthritis, hallux abducto valgus with arthritis, unstable/painful joint from previous surgery.
• Technological Characteristics: Double-stemmed, silicone, hinged midsection, titanium press fit grommets, angled hinge block, and tapered stems designed based on resected bone geometry.
• Predicate Device: Swanson Flexible Hinge Toe Implant by Dow Corning (K780132).
• Performance Standards: None specifically for great toe silicone joint implants at the time, but materials for grommets comply with ASTM F 67.

The document states, "There are currently no performance standards for great toe silicone joint implants." This indicates that formal acceptance criteria based on performance standards are not applicable or were not established in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in the provided text.

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