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The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.

The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless-steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The catheter shaft has 3 markers to facilitate ease of use: the distal marker at the tip of the device, the retraction marker in the middle of the shaft, and the preparation (prep) marker near the proximal end. The handle includes a drive wheel and a luer that attaches to a commercially available inflation device via a stopcock. In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface. The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).

This document is a 510(k) summary for the MAKO 7 hysteroscope accessory, which is a re-submission of an already cleared device, K160510. This current submission (K182975) is for an update to the Instructions for Use (IFU) to modify a warning and update related directions for use. Therefore, no new performance data was generated for the current submission as the existing performance data from K160510 is considered applicable.

Here's a breakdown of the requested information based on the provided text, noting that much of it points to the previous submission (K160510) as the source of the data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K182975 does not detail specific acceptance criteria or quantitative performance results for the MAKO 7. It states that "No performance testing is required to evaluate the update of the Instructions for Use (IFU)." Instead, it refers to performance data submitted for the currently cleared MAKO 7 (K160510).

The types of performance testing mentioned as being applicable from K160510 include:

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

The document for K182975 does not provide sample sizes or data provenance for a test set, as no new performance testing was conducted for this submission. It references "Clinical performance data... submitted for currently cleared MAKO 7 (K160510)". To get details about the sample size and provenance, one would need to consult the K160510 submission.

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

This information is not provided in the K182975 submission. The document mentions "clinical performance data which demonstrated ability to navigate the target anatomy and obtain a sample sufficient for cytological evaluation submitted for currently cleared MAKO 7 (K160510)", but does not specify how ground truth was established or the experts involved.

4. Adjudication Method for the Test Set

This information is not provided in the K182975 submission, as no new performance testing was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This question is not applicable. The MAKO 7 device is described as a "hysteroscope accessory" for collecting cell samples, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in a diagnostic context.

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

This question is not applicable. The MAKO 7 is a physical medical device (an accessory for a hysteroscope), not an algorithm or software-only device.

7. The Type of Ground Truth Used

The clinical performance data mentioned is related to the device's ability to "navigate the target anatomy and obtain a sample sufficient for cytological evaluation." This implies that the ground truth for collected samples would likely be cytological evaluation (pathology) to confirm the sufficiency and quality of the obtained sample. The ability to navigate the anatomy would likely be confirmed by direct observation during a procedure. However, precise details are not available in this document.

8. The Sample Size for the Training Set

This information is not provided in the K182975 submission, as no new performance testing or machine learning models (which typically require training sets) were involved in this submission.

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

This information is not provided in the K182975 submission, as no new performance testing or machine learning models were involved.

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The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.

The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock.

In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface.

The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).

Here's an analysis of the provided text regarding the acceptance criteria and study for the MAKO 7 device.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided does not explicitly present a formal "acceptance criteria" table with specific pass/fail thresholds. However, we can infer the key performance metrics and their reported outcomes from the "Clinical testing" section.

Note: The "Implicit Acceptance Criteria (Inferred)" column is based on common regulatory expectations for medical device performance. The document doesn't explicitly state numerical targets for mechanical or ergonomic testing, but the inclusion of these tests implies successful completion.

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

• Clinical Test Set:

  • Sample Size: 40 subjects (80 fallopian tubes)
  • Data Provenance: Prospective, single-arm clinical study. Country of origin not explicitly stated, but typically assumed to be within the country of submission (USA for FDA).

• Mechanical Test Set:

  • Sample Size: n=15 for each of the following tests: Dimensional, Deployment, Inflation Pressure.

• Ergonomics Test Set:

  • Sample Size: 3 physicians per parameter.

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

• Clinical Study (Cytological Evaluation):

  • Number of Experts: One study pathologist.
  • Qualifications: "The study pathologist" is mentioned, implying a qualified individual in pathology, likely with expertise in cytological evaluation. Specific years of experience or board certifications are not provided.

• Ergonomics:

  • Number of Experts: 3 physicians.
  • Qualifications: "Physician" is mentioned. Specific qualifications (e.g., gynecologist, experience with hysteroscopy) are not detailed but are implied by the nature of the device.

4. Adjudication Method for the Test Set

• For the cytological evaluation ground truth in the clinical study, the text states, "The study pathologist determined that 70/71 (99 %) of the samples were adequate for cytological evaluation." This indicates a single expert's determination, with no mention of a formal multi-reader adjudication method (e.g., 2+1, 3+1).
• For access success/failure, the determination appears to be based on direct observation during the procedure and confirmed by methylene blue dye injection in cases of non-access. This is a procedural outcome, not typically subject to expert adjudication in the same way as image interpretation.

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

No. The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers' improvement with or without AI assistance. This device is a physical sample collection tool, not an AI-driven diagnostic or imaging interpretation system.

6. Standalone Performance

Yes. The clinical study of the MAKO 7 evaluated the standalone performance of the device in its intended use: "to demonstrate the safety and effectiveness of the subject device in navigating the fallopian tube and obtaining cell samples." This was an algorithm-only (device-only) evaluation without human-in-the-loop performance being a separate measured outcome. Physician action is required to use the device, but the device's performance in navigating and collecting samples was the primary endpoint.

7. Type of Ground Truth Used

• Clinical Study:

  • Clinical outcomes/observations (ability to navigate, successful sample collection).
  • Pathology (assessment of sample adequacy for cytological evaluation by a study pathologist).
  • Procedural observation (adverse events, methylene blue dye injection for tubal patency).

• Mechanical Testing:

  • Engineering specifications and physical measurements.

• Ergonomics:

  • Expert user (physician) qualitative feedback.

8. Sample Size for the Training Set

The document does not specify a separate training set. This is not an AI/machine learning device, so the concept of a "training set" as it relates to model development is not applicable here. The clinical and non-clinical data described are primarily for verification and validation of the manufactured product.

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

Since there is no training set mentioned or implied for an AI/ML context, this question is not applicable to the MAKO 7 device as described. The ground truth mentioned above relates to the evaluation of the device's performance directly.

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