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

The CAP™ Great Toe Resurfacinq Hemi-arthroplasty implant is a cobalt chrome alloy, 2-piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to provide a smooth surface for the first metatarsophalangeal joint as a the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valqus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The CAP™ Great Toe Resurfacing Hemi-arthroplasty implant consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The first implant component is a Taper Post manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The Taper Post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.

The second implant is an articular component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

The provided text describes the safety and effectiveness of the CAP™ Great Toe Resurfacing Hemi-arthroplasty implant. It is a medical device, and the information presented here pertains to its mechanical performance and substantial equivalence to previously marketed devices, not to the performance of a software or AI/ML-based device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

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)

• The document describes non-clinical mechanical testing of the device components. It does not mention a "test set" in the context of patient data or clinical data.
• The sample sizes for the mechanical tests are not explicitly stated in the provided text.
• Data provenance is not applicable as this relates to mechanical testing, not patient data.

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)

• This is not applicable as the study involves mechanical testing of an implant, not a diagnostic or prognostic device requiring expert interpretation of data. The "ground truth" here is the physical and mechanical properties of the device as measured against established engineering standards.

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

• This is not applicable since the testing is mechanical and does not involve adjudication of expert opinions.

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

• This is not applicable as the device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

• This is not applicable as the device is a physical implant, not an algorithm.

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

• The "ground truth" for this device, in the context of the described testing, is adherence to established industry standards and guidelines for mechanical properties and material performance (e.g., ASTM F1814, ASTM F897, ISO 7206-9, and relevant CDRH Guidance Documents for implants).

8. The sample size for the training set

• This is not applicable; there is no "training set" as this is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable.

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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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Indications for use of this implant are:

• Hallux limitus or hallux rigidous. .
• Painful hallux valgus. .
• . Revision of failed previous surgery.
• Painful arthritis. .

The Metal Hemi Toe implant is a cobalt chrome alloy, 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. Primary fixation of the grit-blasted version of the device is via a press fit. This is consistent with the description and intended use of the Swanson Titanium Great Toe Implant. The titanium plasma spray coated version of this device is intended for use with bone cement.

This 510(k) submission for the Futura Biomedical Metal Hemi Toe Implant is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, it does not contain a study with detailed acceptance criteria and performance metrics in the way a clinical trial or a machine learning device study would. Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics and intended use.

Here's an analysis based on the provided document:

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

• Design
• Material composition
• Fixation method
• Sizing | Design: Anatomic design to minimize complications (joint instability, shortening, painful/limited ROM), thin inferior aspect for flexor brevis tendon.
  Material: Cobalt Chrome Alloy (main difference from predicate, which is Titanium).
  Fixation: Press fit for grit-blasted version, bone cement for titanium plasma spray coated version.
  Sizing: Offered in sizes that fit within the size range of the Swanson Titanium Great Toe Implant.
  Both are one-piece, single-stemmed, press-fit into intramedullary canal, with a curved articular surface. |
  | Safety and Effectiveness:
  Material differences should not adversely affect safety and effectiveness. | Cobalt Chrome is widely used in metallic implants, commonly favored as an articular surface, and has a 40-year history.
  Referenced studies on metallic hemi toe implants using Cobalt Chrome (Townley and Taranow) or Titanium (Leavitt et al.), and general orthopedic implant use.
  ASTM standards (F 67, F 75) exist for both Titanium and Cobalt-Chromium-Molybdenum for surgical implant applications.
  Conclusion: Material difference (Cobalt Chrome vs. Titanium) does not adversely affect safety and effectiveness. |
  | Predicate Device Performance (Implied Baseline): Implied that the predicate device (Swanson Titanium Great Toe Implant) is safe and effective when marketed. | Not explicitly stated as "performance" in numerical terms, but the predicate's long-standing market presence and FDA clearance (K864492) serve as the benchmark for safety and effectiveness. |

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

This submission does not describe a "test set" in the context of a statistical study with a specific sample size. The device approval is based on a comparison of its design, materials, and intended use against a legally marketed predicate device, rather than a clinical trial with a "test set" of patients.

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, in this context, refers to the established safety and effectiveness of the predicate device and the accepted scientific and engineering principles for implant materials. There's no mention of a ground truth established by a panel of experts for a specific dataset within this document. The FDA's review process itself involves expert evaluation.

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

Not applicable. No "test set" or adjudication method for interpreting outcomes of a clinical study are 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 a premarket notification for a physical medical implant, not an AI/software device. Hence, no MRMC study, human readers, or AI assistance is relevant here.

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

Not applicable. This device is an implant, not an algorithm.

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

The "ground truth" for this 510(k) submission is primarily:

• Regulatory Precedent: The established safety and effectiveness of the predicate device (Swanson Titanium Great Toe Implant, K864492), as determined by its prior FDA clearance and market history.
• Scientific and Engineering Consensus: The widely accepted knowledge and standards regarding the biocompatibility, mechanical properties, and clinical performance of implant materials like Cobalt Chrome and Titanium, supported by published literature (e.g., Townley and Taranow, Leavitt et al.) and ASTM standards (F 67, F 75).

8. The sample size for the training set

Not applicable. This is a device approval based on substantial equivalence, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set mentioned, there is no description of how its ground truth was established.

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