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510(k) Data Aggregation
(61 days)
Disposable Grasping Forceps FG-52D/FG-54D
The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.
The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope. Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.
The provided document is a 510(k) summary for the Olympus Disposable Grasping Forceps FG-52D/FG-54D. It outlines the device's characteristics, indications for use, comparison to a predicate device, and performance data used to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated format. Instead, it lists the types of tests conducted to demonstrate safety and effectiveness. The "acceptance criteria" are implied by the successful completion and positive results of these tests, leading to the conclusion of substantial equivalence.
Here's a re-formatted table based on the provided "Performance Data" section:
| Performance Data Category / Acceptance Criteria (Implied) | Reported Device Performance (Implied by successful completion) |
|---|---|
| Biocompatibility | Met standards per ISO 10993-1:2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), acute systemic toxicity (ISO 10993-11:2017), and material mediated pyrogenicity (USP ). |
| Sterilization Validation | Met standards per ISO 11135:2014. |
| Ethylene Oxide Residuals | Met standards per ISO 10993-7:2008. |
| Packaging Validation & Shelf Life | Met standards in accordance with ISO 11607-1:2019 and ASTM F1980-16. |
| Mechanical Testing & Comparative Testing | Verified device performance for: Insertion force/Withdrawal force, Handle Operation, Grasping Performance, Strength Testing of the Connection and Distal Tip, and Device Reliability. (Implies successful performance within acceptable limits, though specific values are not provided). |
| Human Factors Testing | Conducted. (Implies safe and effective usability, though specific findings are not detailed). |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test conducted. It generally states that "Performance Data" was provided. For the provenance, the data seems to be from non-clinical bench testing conducted by the manufacturer, Olympus Medical Systems Corp. The document does not mention the country of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The device is a physical medical instrument (graspers), not an AI/ML algorithm that requires expert labeling for ground truth. The "ground truth" for its performance is established through standardized engineering and biological tests, not expert consensus on data interpretation.
4. Adjudication method for the test set
This information is not applicable as the device is not an AI/ML algorithm that involves human interpretation requiring adjudication.
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
An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical grasping forceps.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through standardized testing methodologies as referenced in the performance data section (e.g., ISO standards for biocompatibility, sterilization, packaging, and specific mechanical tests like insertion force, grasping performance, and strength testing). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML validation for this type of medical device.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML algorithm.
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