(72 days)
The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
The Implantable Clip is a sterile single use device indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The clip is manufactured from implant grade titanium. The clips are supplied pre-packaged in a preassembled cartridge loaded with 14 functional clips. The clip applier system used to deliver the clips consists of the disposable clip cartridge and a reusable handle which provide the mechanical mechanism for storing, advancing and delivering the implantable clips. The system is designed for use with an 11mm diameter or larger trocar cannula.
The provided text is a 510(k) summary for an Implantable Clip and does not contain detailed information about acceptance criteria and a study that definitively proves the device meets those criteria in the way a diagnostic AI device disclosure would.
The document states:
"PERFORMANCE DATA SUMMARY: The performance and functional testing of the Implantable Clip included tests to analyze the jaw occlusion force of the clip appliers used with the clips discussed in this submission, leak pressure tests on vessels ligated by the clips and clip retention force of the clips. The performance and functional testing demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed."
This is typical for a medical device 510(k) submission where "substantial equivalence" to a predicate device is the primary pathway for clearance, rather than a performance study demonstrating meeting specific quantitative acceptance criteria for a novel diagnostic algorithm.
Therefore, many of the requested details about acceptance criteria, study design involving test sets, experts, ground truth, and AI-specific metrics (MRMC, standalone performance, training sets) are not applicable or provided in this type of submission.
However, I can extract the implied acceptance criteria based on the testing performed and articulate what would be expected if this were a typical AI/diagnostic device submission.
Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Jaw Occlusion Force: Acceptable force to ensure proper closure and secure ligation. | Performance and functional testing demonstrated substantial equivalence to predicate devices, indicating acceptable jaw occlusion force. |
| Leak Pressure: Ability to withstand specified pressure without leakage in ligated vessels. | Performance and functional testing demonstrated substantial equivalence to predicate devices, indicating acceptable leak pressure. |
| Clip Retention Force: Acceptable force to retain the clip on the vessel/structure post-ligation. | Performance and functional testing demonstrated substantial equivalence to predicate devices, indicating acceptable clip retention force. |
| Safety and Effectiveness: No new safety and effectiveness issues compared to predicate devices. | The device "introduces no new safety and effectiveness issues when used as instructed," suggesting established safety and effectiveness through substantial equivalence. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "performance and functional testing" which would involve a sample size but the specific number of clips, appliers, or vessels tested is not provided.
- Data Provenance: Not specified. Given the nature of a 510(k) for a physical implantable device, this would typically involve in-house laboratory testing or animal studies, rather than a clinical dataset from a specific country. It is almost certainly prospective testing performed for the submission.
3. Number of Experts and Qualifications
- Number of Experts: Not applicable/not specified. The testing described (jaw occlusion, leak pressure, retention force) would typically be performed by engineers or technicians in a laboratory setting, not by clinical "experts" establishing ground truth in the way a diagnostic study would.
- Qualifications: Not applicable/not specified.
4. Adjudication Method
- Adjudication Method: Not applicable. This type of testing does not involve subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is a physical implantable device, not a diagnostic algorithm, so an MRMC study is not relevant or performed.
6. Standalone Performance (Algorithm Only)
- Standalone Performance: Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Ground Truth: For the "Performance and Functional Testing," the ground truth would be based on physical measurements and objective criteria established through engineering specifications and industry standards for surgical clips, often benchmarked against predicate devices. For example:
- Jaw Occlusion Force: Measured in units of force (e.g., Newtons) against a predefined threshold.
- Leak Pressure: Measured in units of pressure (e.g., mmHg) at which a leakage occurs, verified against predicate device performance or clinical requirements.
- Clip Retention Force: Measured in units of force required to dislodge the clip, against predefined thresholds.
8. Sample Size for Training Set
- Sample Size: Not applicable. This is a physical device, not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment: Not applicable.
Summary of what the document does tell us about meeting acceptance criteria:
The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing predicate devices (Applied Medical Clip Applier and LIGACLIP™ ERCA). The study, referred to as "performance and functional testing," aimed to demonstrate this substantial equivalence in terms of:
- Jaw occlusion force of the clip appliers.
- Leak pressure of vessels ligated by the clips.
- Clip retention force of the clips.
The document states that this testing "demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This statement serves as the proof that the device meets the implied acceptance criteria for a 510(k) clearance.
§ 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.