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The I emer Medical, Inc. Autoclavable 10MM Laparoscope is intended to be used for visualization of the abdominal cavity during general and thoracic surgery.

General Surgery

• Laparoscopic cholecystectorny, liernia repair, Appendcctomy, Nissen fundal plication, . Diagnosis and Management of acute abdomen
  Thoracic Surgery
• Pericardiectorny, Pneumonectomy, Evaluation of pulmonary nodule, Biopsy, Pleurodosis

The Lemer Medical. Inc. Autoclavable 10MM Laparoscope System is a 10MM diameter laparoscope which may be used during diagnostic and operative laparoscopy procedures for visualization of the abouninal cavity. The laparoscope may be disinfected using bigh level disinfectants or sterilized using ethylene oxide gas or steam autoclave.

This 510(k) submission (K972984) for the Lerner Medical, Inc. Autoclavable 10MM Diagnostic Laparoscope does not contain a study proving the device meets specific acceptance criteria. Instead, it relies on substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested details, such as specific acceptance criteria, device performance, sample sizes, expert qualifications, and ground truth methodologies for a performance study, are not applicable to this submission.

Here's a breakdown of the information that can be extracted or deduced from the provided document:

1. A table of acceptance criteria and the reported device performance

• Not applicable. This submission is for a medical device cleared via the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance data against pre-defined acceptance criteria for a novel technology. The "performance" is inherently assumed to be equivalent to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No test set data from a performance study 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)

• Not applicable. No ground truth establishment for a test set is discussed.

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

• Not applicable. No test set or adjudication method is described.

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 a basic laparoscopic instrument, not an AI-powered diagnostic tool. An MRMC study is irrelevant.

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

• Not applicable. This device is an optical instrument, not an algorithm.

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

• Not applicable. No performance study is detailed that would require a defined ground truth.

8. The sample size for the training set

• Not applicable. This is a hardware device; machine learning training sets are not relevant here.

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

• Not applicable. See point 8.

Summary of what IS available based on the 510(k) document:

The Lerner Medical, Inc. Autoclavable 10MM Laparoscope was determined to be substantially equivalent to a legally marketed predicate device:

• Predicate Device: Cuda Products Corporation Autoclavable Laparoscope (510(k)#: K935818)
• Basis for Equivalence: The submission implies that the design, materials, and intended use of the Lerner Medical device are sufficiently similar to the predicate device such that it raises no new questions of safety or effectiveness. The key feature highlighted is its "autoclavable" nature, which the predicate also possesses.
• Intended Use: For visualization of the abdominal cavity during general and thoracic surgery.
  • General Surgery indications: Laparoscopic cholecystectomy, hernia repair, appendectomy, Nissen fundoplication, diagnosis and management of acute abdomen.
  • Thoracic Surgery indications: Pericardiectomy, pneumonectomy, evaluation of pulmonary nodule, biopsy, pleurodesis.

In essence, the "study" proving the device meets "acceptance criteria" is the demonstration of substantial equivalence to an already cleared device, as reviewed by the FDA. The "acceptance criteria" here are implicitly the safety and effectiveness profile of the predicate device, which the new device is claimed to match.

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