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

The MAKO Device is a hysteroscope accessory intended to collect cell samples from the proximal 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.

The document describes the MAKO Device, a hysteroscope accessory for collecting cell samples from the proximal fallopian tube for cytological evaluation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for primary efficacy endpoints. Instead, it describes what was evaluated for safety and effectiveness in the clinical study. Based on the "Clinical testing" section, we can infer the following:

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

The clinical study served as the primary test set for demonstrating safety and effectiveness.

• Sample Size: 40 women (totaling 80 fallopian tubes, as each woman has two).
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "prospective, single-arm clinical study."

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical study's cytological evaluation. It only states the "ability to obtain samples that are adequate for cytological evaluation" was assessed. This usually implies evaluation by trained cytopathologists, but their number and specific experience are not provided.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study results.

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

No explicit mention of an MRMC comparative effectiveness study was made. The clinical study was a "single-arm" study, focusing on the device's performance in isolation rather than comparing it to human readers with or without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided.

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

Not applicable. The MAKO Device is a physical medical device (hysteroscope accessory) that requires a human operator (physician) for its use. The concept of "standalone algorithm performance" typically applies to AI/software-as-a-medical-device (SaMD).

7. Type of Ground Truth Used:

For the clinical study, the ground truth for "adequate cell samples for cytology" would have been established by cytological evaluation performed by trained professionals (e.g., cytopathologists). The success of "navigating the fallopian tubes" would have been determined by the physician performing the procedure and potentially confirmed through visual inspection (hysteroscopic view) and the successful collection of a sample.

8. Sample Size for the Training Set:

The document does not describe a "training set" in the context of an algorithm or AI. The MAKO Device is a physical medical device. The "training" for such devices typically refers to the design, engineering, and iterative testing phases, not a data-driven training set for an AI model.

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

As there is no AI training set mentioned, this question is not applicable. The device's design and functionality would have been validated through various engineering tests and simulations (bench testing) and then confirmed in human clinical trials.

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