Search Results

Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.

Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.

The provided text describes a 510(k) premarket notification for the Cartiva® SCI Reusable Instrumentation Set. This submission is for orthopedic surgical instrumentation, specifically an instrumentation set, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for this instrumentation set, specifically the addition of two new sizes (6mm and 12mm) to an existing product line.

Here's an analysis of the provided information, tailored to the context of a medical instrumentation submission:

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)

This information is not provided in the document. The filing is for a physical medical device (instrumentation set), and the "testing" performed relates to material properties, cleaning, sterilization, and basic functionality, not clinical performance with a test set of data in the way an AI/ML device would be evaluated. The tests performed are likely in vitro and bench-top studies.

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 information is not applicable as the device is an instrumentation set and does not involve AI/ML or diagnostic assessment that would require clinician-established ground truth. Expert involvement would be in the design, testing protocols, and assessment of physical device performance, but not in establishing ground truth for diagnostic accuracy.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable. The device is an instrumentation set, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is an instrumentation set, not an algorithm.

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

This information is not applicable for the clinical context as the device is an instrumentation set. For the engineering performance testing, the "ground truth" would be established by validated test methods (e.g., ISO, AAMI, ASTM standards) against predetermined specifications for material properties, sterility assurance levels, cleaning efficacy, and functional integrity.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.

Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.

The provided document describes the 510(k) premarket notification for the "Cartiva® SCI Disposable Instrumentation Set". This device is orthopedic surgical instrumentation, and the 510(k) is for a modification to allow for a single-use, disposable option, with minor material changes.

It is important to note that this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cartiva SCI Instrumentation) by showing that the modifications do not raise new questions of safety or effectiveness. Therefore, the "acceptance criteria" and "device performance" in this context refer to the successful completion of various tests to confirm that the disposable set retains the safety and performance of the original, reusable device. There isn't a direct "performance metric" in the typical sense of diagnostic or AI device studies (e.g., sensitivity, specificity).

Here's a breakdown of the requested information 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 does not specify exact sample sizes for each test (e.g., number of units tested for biocompatibility, sterility, or functional testing). The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond the fact that testing was "carried out" and the manufacturer is based in Alpharetta, Georgia, USA. These are laboratory/bench tests, not clinical studies involving patient data.

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

This question is not applicable. For a device like surgical instrumentation, "ground truth" as it relates to expert consensus on clinical findings is not relevant. The ground truth for these tests is defined by established scientific and regulatory standards (e.g., ISO, ASTM standards) and the physical/chemical properties of the materials and device.

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

This question is not applicable. The tests conducted are laboratory-based, objective measurements against established standards, not studies requiring human interpretation or adjudication in the sense of clinical image analysis or diagnosis.

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 question is not applicable. This device is surgical instrumentation, not an AI, diagnostic, or imaging-related device. There was no MRMC study or AI component. The document explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are all preserved."

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

This question is not applicable. This device is surgical instrumentation. There is no algorithm or AI component involved.

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

For the various tests, the "ground truth" is defined by the established scientific and regulatory standards themselves (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization, ASTM F 1980 for accelerated aging, ASTM D4169 for shipping). The device's performance is measured against the specifications and requirements outlined in these standards.

8. The sample size for the training set

This question is not applicable. This device is surgical instrumentation; there is no "training set" in the context of machine learning or AI.

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

This question is not applicable. As there is no AI component or training set, this information is irrelevant.

Ask a specific question about this device

The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.

The ProxiFuse Hammer Toe Device consists of three components: 1) the implant, 2) deployment instrumentation, and 3) bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves multiple functions: 1) shifting of the PEEK Body and 2) applying tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint (PIPJ).

The provided text describes a medical device, the ProxiFuse Hammer Toe Device, and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices through performance testing. However, it does not describe a study involving an AI/Machine Learning device or its acceptance criteria.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML-based medical devices. Since the ProxiFuse Hammer Toe Device is a physical implant and not an AI/ML device, these details are not present in the provided documentation.

Therefore, I cannot provide the requested information. The document details bench testing for a physical implant, not a study for an AI/ML device.

Ask a specific question about this device