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The Innovia InnoPort™ Laparoscopic Access Device is a sterile, single use device intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.

The InnoPort Laparoscopic Access Port is a sterile, single use laparoscopic access device comprised of flexible polymer and a rigid plastic plate. The InnoPort forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the infor system to provide intra-abdominal pneumoperitoneum, and a fifth port coulties of the insunprocedural smoke removal. The instrument ports are designed to accommodate 5 mm dinerer laparoscopic instruments while allowing full maneuverability without loss of neumperioneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.

The prompt asks for acceptance criteria and study details related to a medical device's performance. However, the provided document is a 510(k) summary for the "InnoPort™ Laparoscopic Access Port," which is a physical medical device, not an AI or software-based device.

Therefore, many of the requested categories in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set sample size," and "ground truth for training set," are not applicable to this type of medical device and its associated 510(k) submission.

The document focuses on demonstrating substantial equivalence to a predicate device through bench and in vivo tests, verifying its mechanical performance and safety, rather than evaluating an algorithm's diagnostic accuracy against a ground truth.

Here's an attempt to answer the applicable parts of the prompt based only on the provided text, while explicitly stating when information is not available or not applicable:

Acceptance Criteria and Device Performance Study Details for Innovia InnoPort™ Laparoscopic Access Port

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding performance metrics. Instead, it broadly states the device was tested to verify its ability to meet performance specifications related to the intended use.

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

• Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "bench and in vivo tests" but does not quantify the number of tests, devices, or subjects used.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing included "bench and in vivo tests," which implies a combination of laboratory testing and potentially animal or human studies, but the specifics are not detailed. It is a prospective study in the sense that the testing was conducted specifically for this 510(k) submission.

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

• Not Applicable. This device is a physical laparoscopic access port, not an AI or diagnostic software. Ground truth in the context of expert consensus or diagnostic accuracy is not relevant for its performance evaluation in this 510(k) submission. The performance tests would likely involve engineers and possibly surgeons in simulated or live surgical settings, but not for "establishing ground truth" in a diagnostic sense.

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

• Not Applicable. As a physical device, adjudication methods for diagnostic output are not relevant. Performance was likely determined by direct observation, measurement, and functional assessment during bench and in vivo testing.

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. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical instrument and does not involve "human readers" or AI assistance in the way an MRMC study evaluates.

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

• Not Applicable. This refers to the standalone performance of an algorithm. The InnoPort™ is a physical surgical device. Its "standalone performance" refers to its mechanical and functional integrity in isolation, which was assessed through bench testing and its in vivo behavior, but not as an algorithm.

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

• Not explicitly stated in these terms, but inferred: For a physical medical device like this, the "ground truth" for its performance would implicitly be defined by engineering specifications, material standards, biocompatibility requirements, recognized surgical practices, and the functional capabilities demonstrated by the predicate device. The in vivo tests would assess real-world functionality and safety. The performance is compared to the predicate device's established safety and effectiveness profile.

8. The sample size for the training set:

• Not Applicable. This concept applies to machine learning models. This device is a physical product, not an AI algorithm, so there is no "training set."

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

• Not Applicable. There is no training set for this type of device.

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The Innovia InnoPort™ Laparoscopic Access Port is a sterile, single use device, intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.

The InnoPort™ Laparoscopic Access Port is a sterile, single use laparoscopic access device made of a flexible Quatromer polymer combined with polycarbonate and polyurethane components. It forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the insufflation system to provide intra-abdominal pneumoperitoneum. The instrument ports are designed to accommodate 5 mm diameter laparoscopic instruments while allowing full maneuverability without loss of pneumoperitoneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.

I am designed to extract and analyze information related to medical device acceptance criteria and performance studies. However, the provided document (K090677) describes a Laparoscopic Access Port, which is a physical surgical device, not a software-based AI device.

Therefore, the concepts of "acceptance criteria for an AI device," "device performance in a study proving AI acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "training set size," and "ground truth for training set" are not applicable to this document.

The document discusses performance and functional testing for the physical laparoscopic device, including bench and in vivo tests to verify its ability to:

• Maintain pneumoperitoneum with minimal leakage.
• Allow introduction and manipulation of instruments.
• Meet performance specifications.

It concludes that the device is "substantially equivalent" to its predicate device and introduces "no new safety or effectiveness issues." This is the standard for 510(k) clearances for physical devices, focusing on safety and equivalence rather than AI-specific performance metrics.

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The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.

The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The provided document describes the Innovia Orbital Tissue Expander (OTE) and its premarket notification to the FDA. While it discusses performance data, it does not present specific, quantitative acceptance criteria for the device's performance that are then directly compared to reported device performance in a tabular format. The document focuses on demonstrating substantial equivalence to a predicate device and showing safety and effectiveness through various tests.

Therefore, for the acceptance criteria table, I will infer the types of performance criteria based on the described tests and present the qualitative findings. It's important to note that the document does not provide numerical thresholds for "acceptance."

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

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

• Animal Study: The document refers to "the animal study" and "all animals" but does not specify the exact number of animals (sample size).
• Data Provenance: The animal study was conducted, which implies prospective data collection, but the country of origin is not specified.

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 evaluating the animal study results (e.g., interpreting CT scans or histology). It states that the qualitative difference "can be observed on CT scans as well as in gross photos" and histology was performed, suggesting expert review, but details are absent.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the animal study results.

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

• No, an MRMC comparative effectiveness study was not done. The document describes bench, in vitro, and animal testing. There is no mention of human readers evaluating cases with or without AI assistance. The device itself is a physical implant, not an AI-driven diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The OTE is a medical device, not an algorithm or software. The performance studies evaluate the physical properties and biological effects of the expander.

7. Type of Ground Truth Used

• For the animal study:
  • Qualitative Observation: Orbital expansion and bone growth compared to the contralateral non-enucleated side (visual assessment on CT scans and gross photos).
  • Pathology/Histology: Histological analysis of tissues for foreign body reaction and normalcy.

8. Sample Size for the Training Set

• The document describes manufacturing of the OTE and subsequent testing. There is no mention of a "training set" in the context of machine learning or algorithm development, as this is a physical medical device. The "training" for the device would be its design and manufacturing processes, which are not quantified in terms of a "sample size" in this context.

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

• Since there is no "training set" in the machine learning sense, this question is not applicable. The "ground truth" for the device's design and manufacturing relies on engineering principles, materials science, and pre-clinical animal models to demonstrate safety and efficacy for human use.

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