(76 days)
The Applied Medical Clip Applier is a sterile single use device intended for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
The Applied Medical Clip Applier consists of a molded plastic clip applier handle with an actuating trigger, a 360° adjustable rotational knob on the shaft, an applicator shaft and clip applier jaws which provide secure placement of the clip to the desired vessel. The applier is sold with a pre-loaded cartridge containing 20 implantable clips. The distal tip of the shaft is a clear material which provides a color coded visual indication of the last four clips. Following release of the last clip, a lockout mechanism is activated which neutralizes the jaw actuating mechanism and prevents unanticipated cutting or pinching from the applier jaws.
The provided text describes a 510(k) summary for a medical device cleared in 1997. This document explicitly states that the Applied Medical Clip Applier is "substantially equivalent to the predicate LIGACLIP™ ERCA Clip Applier device manufactured by Ethicon." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as would be expected for novel AI/ML devices or higher-risk devices today.
Therefore, many of the requested details, particularly those related to AI/ML device performance, ground truth, expert adjudication, and comparative effectiveness studies, are not applicable to this 1997 medical device submission.
Here's a breakdown based on the provided text, addressing the points where information is available or noting where it's not applicable:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics in the provided text. The primary "acceptance criterion" for a 510(k) submission of this nature in 1997 was demonstrating substantial equivalence to the predicate device. This is achieved through functional performance and biocompatibility testing to ensure the new device "introduces no new safety and effectiveness issues."
- Reported Device Performance:
- "Functional performance and biocompatibility tests were performed to verify functional and structural integrity and material safety."
- "All testing demonstrated the Applied Medical Clip Applier introduces no new safety and effectiveness issues when used as indicated."
- The device consists of: "a molded plastic clip applier handle with an actuating trigger, a 360° adjustable rotational knob on the shaft, an applicator shaft and clip applier jaws which provide secure placement of the clip to the desired vessel."
- "The applier is sold with a pre-loaded cartridge containing 20 implantable clips."
- "The distal tip of the shaft is a clear material which provides a color coded visual indication of the last four clips."
- "Following release of the last clip, a lockout mechanism is activated which neutralizes the jaw actuating mechanism and prevents unanticipated cutting or pinching from the applier jaws."
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The text mentions "Functional performance and biocompatibility tests" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any human-patient data, as this was not a clinical trial in the modern sense.
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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. This device is a manual surgical instrument, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for image analysis or similar tasks.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process for a test set is described or implied for this type of device submission.
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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 is a manual surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a manual surgical instrument; there is no "algorithm only" component.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance would be engineering specifications and safety standards, verified through bench testing and biocompatibility assessments, rather than clinical outcome data or expert consensus on diagnostic tasks.
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The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The study proving the device met its "acceptance criteria" (i.e., substantial equivalence to the predicate) consisted of functional performance and biocompatibility tests. While specific details and numerical results are not provided in this summary, the text states: "All testing demonstrated the Applied Medical Clip Applier introduces no new safety and effectiveness issues when used as indicated." This statement confirms that the necessary testing was conducted and presumably met the internal specifications and regulatory requirements for demonstrating equivalence to the predicate device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.