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The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

The provided document is a 510(k) summary for the Millipede 088 Access Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a standalone clinical study to prove the device meets those criteria.

Therefore, the document does not contain the information requested in points 2, 3, 4, 5, 8, and 9, and only partially addresses points 1, 6, and 7.

Here's a breakdown of what can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their conclusions, indicating that the device met "established specifications" or was "suitable for its intended use." However, the specific quantitative acceptance criteria for each test are not provided. The reported device performance is qualitative rather than quantitative in most cases.

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 the sample sizes for the individual performance tests beyond implicitly suggesting multiple samples were tested (e.g., "test specimens," "test articles"). For the Animal Testing, it states "two studies in a porcine model."

The data provenance for the in vitro and animal studies isn't explicitly stated beyond "Good Laboratory Practices" for the animal studies, which is a standard of conduct rather than a geographic origin. No human data is presented.

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 provided as the submission relies on objective performance testing, biocompatibility studies, and animal studies rather than expert-derived ground truth from human data for this type of device.

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

Not applicable. The evaluation methods described are objective performance tests and animal studies, not human data requiring expert adjudication.

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 an access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

Yes, the performance testing described (mechanical, dimensional, coating integrity, etc.) and the animal studies represent "standalone" evaluations of the device's physical and functional properties without human interpretation of data in a clinical context.

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

For the performance and biocompatibility tests, the "ground truth" is defined by the established specifications, relevant ISO standards, and comparison to control devices or predicate devices. For example:

• "The device met established specifications."
• "The test article is non-cytotoxic."
• "The particulate size and count were similar to control devices."
• "The radiopacity of the Millipede 088 Access Catheter was similar to a control device."
• For animal testing, "Usability, radiopacity, thromboresistance, and vessel injury were assessed," and "The results for the subject device were comparable to a control device."

8. The sample size for the training set

Not applicable. This device is a medical catheter and does not involve a "training set" in the context of machine learning or AI. Its performance is evaluated through engineering and biological testing.

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

Not applicable (as above).

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Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).

NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography). The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.

Here's a breakdown of the acceptance criteria and study information for the NAVIPLAN - CT Planning Software for Total Hip Replacement, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with numerical targets and then directly provide "reported device performance" in a separate section. Instead, it describes a software verification and validation testing approach. The "reported device performance" is summarized by the statement: "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." And the overall conclusion: "the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, NAV-IPLAN - CT Planning Software for Total Hip Replacement, is at least as safe and as effective as the legally marketed predicate device, Zedview (K133022)."

Based on the information, the acceptance criteria are implicitly tied to the performance of manual segmentation and landmark positioning. The device is expected to perform at a level comparable to, or as accurate as, manual methods.

2. Sample Size for Test Set and Data Provenance

The document states: "Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." However, it does not specify the sample size used for this testing. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only implies the use of "manual segmentation and landmark positioning" as a reference for comparison.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The study described focuses on comparing the automated software's performance to manual methods, not on human reader performance with or without the software.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance assessment was done. The software verification testing "compare[d] manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning." This implies the algorithm's performance in segmentation and planning was evaluated independently against manual ground truth without a human in the loop of the algorithm's output. The device itself is described as primarily standalone for planning, though its output can be used with a navigation system.

7. Type of Ground Truth Used

The ground truth used was based on manual segmentation and landmark positioning. This can be interpreted as a form of expert consensus or expert-derived ground truth, as manual methods in such a clinical context would typically be performed by trained medical professionals or experts.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

9. How Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for the training set was established.

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