(46 days)
PANTHER Circular The Panther Circular staplers and accessories have application Stapler throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
PANTHER The PANTHER Hemorrhoidal Circular Stapler and accessories Hemorrhoidal have application throughout the anal to perform surgical Circular Stapler treatment of hemorrhoidal disease.
PANTHER Linear The PANTHER Linear Stapler can be applied in abdominal, Stapler thoracic and pediatric surgical procedures for transection or resection of tissue.
PANTHER Linear The PANTHER Linear Cutter Stapler can be applied in abdominal, Cutter Stapler gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
The PANTHER Staplers were sterile(ETO), single-patient-use instruments which 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:
PANTHER Circular Stapler: The PANTHER Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. PANTHER Circular Stapler includes 4 series: FCSM, FCSME, FCSMF, and FCSLWBE.
PANTHER Hemorrhoidal Circular Stapler: The PANTHER Hemorrhoidal Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. The Hemorrhoidal Circular Stapler set includes a Hemorrhoidal Circular Stapler, Suture Threader, Circular Anal Dilator and Purse-string Suture Anoscope. PANTHER Hemorrhoidal Circular Stapler includes 4 series: FCSS, FCSSME, FCSSWAE and FCSSWBE.
PANTHER Linear Stapler: The PANTHER Linear Stapler places a double or triple staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. and is available in 30 mm, 45 mm, 60 mm, 75 mm and 90 mm staple 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. PANTHER Linear Stapler includes 2 series: FLSL, FLSLE
PANTHER Linear Cutter Stapler: The PANTHER Linear Cutter Staplers place two double staggered rows of titanium staples in organs and tissues to anastomose the internal tissues and simultaneously cut and divide between the two rows during surgical procedures. The PANTHER Linear Cutter Staplers is available in six staple line lengths (55, 60, 75, 80, 100 or110mm). 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. PANTHER Linear Cutter Stapler includes 2 series: SSAA, SSAB.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PANTHER Group of Surgical Staplers:
The provided 510(k) summary for the PANTHER Group of Surgical Staplers describes a premarket notification for devices that are "substantially equivalent" to predicate devices. This type of submission relies on demonstrating similarity to already legally marketed devices, rather than establishing entirely new performance criteria through extensive clinical trials.
Therefore, the acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices, and the "study" is a bench testing comparison, not a human clinical trial.
Here's the breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (AutosutureTM EEA surgical Stapler, PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories, AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER, AUTO SUTURE DISPOSABLE GIA SURG. STAPLER) | "Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the PANTHER Stapler is substantially equivalent to the predicate devices." |
"There are no substantial differences between the PANTHER Group of Surgical Stablers and the predicate devices. They have the same or similar indications for use. In addition, the minor differences in the technological characteristics do not raise issues of safety and effectiveness." |
| Performance to Internal Specifications | "Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Notionally, a "test set" and "training set" as understood in machine learning are not applicable here. This application is for physical surgical staplers, and the "testing" refers to bench testing (laboratory-based performance evaluation). The document does not specify the number of stapler units or specific test configurations used in the bench testing.
- Data Provenance: The bench testing was performed by "B.J.ZH.F. Panther Medical Equipment Co. Ltd" in China. The data's provenance is therefore the manufacturer's internal testing facilities. It is retrospective in the sense that it evaluates the manufactured device's performance against pre-defined specifications and predicate device performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of expert consensus in clinical imaging or diagnosis is not relevant for this type of device and submission. The "ground truth" for the bench testing would be objective measurements according to engineering and performance standards, and comparison to the predicate device specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies, which is not described for this bench testing.
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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:
- No. An MRMC comparative effectiveness study is not relevant here. This is a surgical stapler, not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical, mechanical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" would be objective engineering and performance metrics (e.g., staple formation consistency, staple line strength, cutting efficiency, deployment force, biocompatibility of materials, etc.) as evaluated against internal specifications and the known performance characteristics of the predicate devices. This does not involve expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.
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The sample size for the training set:
- Not applicable. The concept of a "training set" is typically used in machine learning. For this device, there is no AI algorithm being trained. The design and manufacturing process would involve iterative development and testing, analogous to "training" in a broad sense, but not with a specified "training set" of data as in AI.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI sense. The design specifications and performance objectives for the stapler would have been established based on engineering principles, industry standards for surgical staplers, and the characteristics of the predicate devices.
In summary, the K103470 submission is a traditional 510(k) based on substantial equivalence. The "study" mentioned refers to bench testing that verified the device met internal specifications and demonstrated equivalence to the identified predicate devices in terms of function and safety. It did not involve human subjects, AI, or expert consensus in the manner one would see for a diagnostic device.
§ 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.