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Operative and Diagnostic Arthroscopy for visual imaging and light transmission to the operative area.

The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.

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The provided document is a 510(k) premarket notification letter from the FDA for an "Arthroscope" manufactured by Medifix, Inc. This letter confirms that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is a regulatory approval letter based on substantial equivalence, not a study report detailing acceptance criteria and performance data for the device itself. It confirms that the device is similar enough to previously approved devices that it doesn't require a new, extensive clinical trial.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for the Arthroscope.

The prompt's questions are designed for a document describing a clinical study or a performance validation report, which this 510(k) clearance letter is not.

To answer your questions, if this were indeed a study report, the typical information would be as follows:

1. Table of Acceptance Criteria and Reported Device Performance: This would typically be a table showing specific metrics (e.g., sensitivity, specificity, accuracy, precision for diagnostic devices, or specific physical performance measures for instruments) and the required threshold for acceptance versus the actual measured performance of the device in a study.
2. Sample Size Used for the Test Set and Data Provenance: This would detail how many cases or patients were included in the evaluation set, the demographics, and where the data originated (e.g., retrospective analysis of a hospital database from the USA, prospective collection from a multi-center trial in Europe).
3. Number of Experts Used to Establish the Ground Truth and Qualifications: This would specify how many human experts (e.g., 3 board-certified radiologists, 5 orthopedic surgeons) independently reviewed the test cases and their experience level.
4. Adjudication Method: How disagreements among experts were resolved (e.g., a "2+1" rule where if two experts agree, that's the truth, and a third expert adjudicates if there's a split; or a "3+1" rule with a super-expert, or a simple majority vote).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This would describe if human readers evaluated cases both with and without the AI assistance, and the statistical measure of improvement (e.g., AUC increase, sensitivity improvement).
6. Standalone Performance: This refers to the algorithm's performance without any human intervention.
7. Type of Ground Truth Used: The definitive truth used to evaluate the device. For example:
   • Expert Consensus: The agreed-upon diagnosis or finding by a panel of experts.
   • Pathology: Histopathological reports from biopsies or surgical resections.
   • Outcomes Data: Long-term follow-up of patients to confirm a disease or condition.
   • Radiological Follow-up: Subsequent imaging studies confirming findings.
8. Sample Size for the Training Set: The number of cases or data points used to develop and train the device's algorithms or models.
9. How the Ground Truth for the Training Set was Established: Similar to point 7, but specifically for the data used during the development phase.

Since the provided document is a 510(k) letter, none of this specific study-related information is available within the text.

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Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.

Not Found

This document is a letter from the FDA regarding a medical device, specifically a "Medifix Single and Double Puncture Laparoscope." It states that the device has been reviewed and determined to be "substantially equivalent" to devices marketed prior to May 28, 1976. This letter is a clearance to market the device.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The letter is primarily a regulatory communication confirming that the device can be legally marketed based on its substantial equivalence to existing devices. It does not delve into the technical validation and performance metrics typically associated with studies that establish acceptance criteria for a new or modified device.

Therefore, I cannot fulfill your request for the detailed information because it is not present in the provided document.

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Operative and Diagnostic Cystoscopy for visual imaging and light transmission.

Cystoscopes

The provided 510(k) submission for the Medifix Inc. Cystoscopes is very brief and lacks detailed information regarding specific performance testing and acceptance criteria. It primarily focuses on demonstrating substantial equivalence to older predicate devices through design comparisons.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "Cystoscope prototypes" but does not indicate how many prototypes were tested or how many individual test units were subjected to "extensive mechanical and thermic stress testing."
• Data Provenance: Not specified. The data would be prospective, as it involves testing their own prototypes. However, the location or specific conditions of the testing are not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document only states "We compared our Cystoscope prototypes in detail to much older equipment..." implying internal assessment, but no details on who performed this assessment or their qualifications.

4. Adjudication method for the test set

• Adjudication Method: Not specified. It appears that the assessment was internal ("We compared..."), implying no formal external adjudication process.

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

• MRMC Study: No. This device is a passive optical instrument (cystoscope), not an AI-powered diagnostic tool. Such a study would not be relevant.

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

• Standalone Performance: Not applicable. This is not an algorithm-based device.

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

• Type of Ground Truth: The "ground truth" for the performance testing appears to be comparison to established, predicate devices. The submission states they compared their prototypes to "much older equipment, manufactured by R.Wolf and other Manufacturers" and concluded they are "as safe and effective." For the design comparison, the "ground truth" was the "manufacturing drawings with corresponding devices from R.Wolf." There is no mention of expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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