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510(k) Data Aggregation
(106 days)
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.
Performance Metric | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
---|---|---|
Clinical - Device Navigate Fallopian Tube | High percentage of successful navigation, considering pre-existing anatomical factors. | Access achieved in 71/80 (89%) fallopian tubes. |
Clinical - Collect Sample Adequate for Cytological Evaluation | High percentage of collected samples deemed adequate for cytological evaluation by a pathologist. | 70/71 (99%) of samples from accessed tubes were adequate. |
Clinical - Adverse Events | No device-related adverse events. | No device-related adverse events reported. |
Mechanical - Dimensional | Device dimensions meet specifications (assumed to ensure proper function and compatibility). | "Dimensional" testing performed (passed, implied). |
Mechanical - Deployment | Device balloon deploys as intended (assumed to ensure effective sample collection). | "Deployment" testing performed (passed, implied). |
Mechanical - Inflation Pressure | Device balloon inflates to specified pressure (assumed to ensure effective sample collection and prevent damage). | "Inflation Pressure" testing performed (passed, implied). |
Ergonomics - Physician Feedback | Positive feedback from physicians on handle, drive wheel, hysteroscopic visibility, and adherence to IFU. | Confirmed handle ergonomics, drive wheel ergonomics, hysteroscopic visibility of balloon deployment, and ability to follow the IFU. |
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
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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).
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Mechanical Test Set:
- Sample Size: n=15 for each of the following tests: Dimensional, Deployment, Inflation Pressure.
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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
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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.
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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
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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).
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Mechanical Testing:
- Engineering specifications and physical measurements.
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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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