(171 days)
The Aponos Medical Padlock Clip™ is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs.
The Padlock Clip is indicated for clip placement within the Gastro-intestinal (GI) tract for the purpose of:
- Endoscopic marking of lesions. .
- Hemostasis for .
- Mucosal/Sub mucosal defects o
- o Bleeding Ulcers
- Arteries
The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy (Nitinol®) for tissue approximation device with opening sizes of 6 to 24mm on a flexible delivery system.
Here's an analysis of the provided text regarding the Aponos Medical Padlock Clip™, focusing on acceptance criteria and supporting studies.
Based on the provided document (K120814), the details regarding acceptance criteria and a study to prove the device meets them are very limited. This document is a 510(k) summary and clearance letter, indicating it focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria in the way a PMA submission might.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria (e.g., clip deployment success rate, hemostasis efficacy, closure success rate for perforations) | Not explicitly stated in this document. The document states: "Aponos Medical has conducted appropriate testing and has determined that the Padlock Clip ligation clip is acceptable for its intended use." |
| Functional tests (e.g., clip opening size integrity, delivery system flexibility and deployment) | "The results of animal and performance testing show no new issues of safety or effectiveness." (No specific results or acceptance criteria provided) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: The document mentions "animal and performance testing" but does not specify the country of origin or whether these were retrospective or prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable/Not specified. The document does not describe the use of an expert panel to establish ground truth for a test set in the context of clinical performance evaluation. The testing mentioned appears to be more focused on technical performance and animal studies.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not mentioned. This type of study is typically for evaluating the performance of AI algorithms in interpreting medical images, and the Padlock Clip™ is a physical medical device, not an AI diagnostic tool.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithms. The Padlock Clip™ is a physical device, so a "standalone" algorithm performance study is not relevant. The document refers to "animal and performance testing" which are standalone device evaluations, but not in the context of AI.
7. The Type of Ground Truth Used
- The document implies that "appropriate testing" and "animal and performance testing" were conducted to demonstrate safety and effectiveness. However, it does not detail the specific "ground truth" used for these tests. For a device like a ligation clip, ground truth would typically come from direct observation of outcomes (e.g., successful hemostasis, complete closure, proper marking) by trained personnel during the "animal and performance testing."
8. The Sample Size for the Training Set
- Not applicable. This question refers to the training of an AI algorithm. The Padlock Clip™ is a physical device, not an AI system, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, this pertains to AI algorithms.
Summary and Limitations:
The provided document is a 510(k) summary for a medical device (Padlock Clip™), not for an AI algorithm. Therefore, many of the questions regarding AI-specific studies (MRMC, standalone algorithm performance, training/test sets for AI, expert ground truth for AI) are not applicable.
For the physical device itself, the document states that "appropriate testing" and "animal and performance testing" were conducted, concluding that the device is "acceptable for its intended use" and shows "no new issues of safety or effectiveness." However, it does not provide specific details about:
- The acceptance criteria (e.g., quantitative thresholds for success rates).
- The exact protocols, sample sizes, or results of these "animal and performance testing."
- The specific methods for establishing ground truth during these tests.
This level of detail is typically found in the full 510(k) submission or supporting technical documentation, which is not included in this public summary. The purpose of this summary is primarily to establish substantial equivalence to a predicate device (OVESCO Endoscopy AG OTSCTM).
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.