(43 days)
Frankenman Staplers are indicated as follows:
Disposable Alimentary Canal Stapler: The Frankenman Disposable Alimentary Canal Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.
Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid: The Frankenman Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.
Disposable Reloadable Linear Stapler and Reloads: The Frankenman Disposable Reloadable Linear Stapler (and Reloads) is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Disposable Reloadable Linear Cutter Stapler and Reloads: The Frankenman Disposable Reloadable Linear Cutter Stapler (and Reloads) has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
The Frankenman Staplers were designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go. Specifics for each stapler include:
- The Frankenman Disposable Alimentary Canal Stapler places a circular, double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 28mm, or 32mm stapler.
- The Frankenman Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal mucosa above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal mucosa. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
- The Frankenman Disposable Reloadable Linear Stapler places a double(or triple in the case of the LS30-W) staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. The Linear Stapler is available in 30mm, 45mm, 60mm, and 90mm line lengths for use in various applications. The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument.
- The Frankenman Disposable Reloadable Linear Cutter Stapler delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. The use of the instrument with staple buttressing materials, or across a previous staple line, may reduce the number of firings.
The provided text describes the 510(k) summary for the Frankenman Family of Surgical Staplers. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly provide a table of acceptance criteria with numerical targets. Instead, it states that the devices were tested to validate physical and performance characteristics, and a performance test was conducted for substantial equivalence.
| Characteristic | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Physical | Not explicitly detailed (implied to match predicate) | Appearance, dimensions, stapler compatibility with cartridge, sterility (per ISO 11737 and EN 552) were validated. |
| Performance | Not explicitly detailed (implied to match predicate) | Strength, closure performance were validated. |
| Substantial Equivalence | Not explicitly detailed (implied to be equivalent to predicate clinical performance) | Design and construction of Frankenman Disposable Alimentary Canal Stapler and Disposable Reloadable Linear Stapler were determined to be substantially equivalent to analogous Ethicon staplers based on performance testing. Clinical testing of each stapler line produced superior results (post-operative healing, pain management, anastomotic leakage, bleeding) compared to manual suturing and competitors' devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the "performance test" comparing Frankenman staplers to Ethicon staplers, nor for the "clinical testing."
- Sample Size: Not specified.
- Data Provenance: The manufacturer is Suzhou Frankenman Medical Equipment Co., Ltd. located in China. The document does not specify the country of origin for the data (e.g., where clinical trials were conducted). It also does not explicitly state if the studies were retrospective or prospective, though "clinical testing" usually implies prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies mentioned are performance tests and clinical testing, but no details are given about the involvement or qualifications of experts in establishing ground truth for these tests.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study is not mentioned. The studies described are related to physical and performance characteristics of the staplers and clinical outcomes compared to manual suturing and competitors' devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a surgical stapler, not an algorithm or AI.
7. The Type of Ground Truth Used
Based on the description:
- For the physical and performance characteristics (strength, closure performance, appearance, dimensions, sterility), the ground truth would likely be established through engineering specifications, standardized test methods, and potentially comparison to known values or validated measurements.
- For the "clinical testing," the ground truth would be based on clinical outcomes data (post-operative healing, pain management, anastomotic leakage, bleeding) collected from patients, likely adjudicated by medical professionals, although the specifics are not detailed.
8. The Sample Size for the Training Set
This is not applicable as the device is a surgical stapler, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.