(32 days)
The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
The CONTOUR® TRANSTAR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers three staggered rows of titanium staples, with a knife between the first and second row of staples, and creates a 30 mm curved transection. The device is designed with a feature that prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded seven times, for a maximum of eight firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on the patient side, one staggered row of staples on the specimen side, an anvil, a cutting washer, a retaining pin, a knife guide pin, and a staple retainer. Additional reload cartridges will be available in one size: a green cartridge for compressed tissue with a thickness of 2.0mm.
The CONTOUR® TRANSTAR™ Curved Cutter Stapler is packaged sterile as a single patient use device with two accessories, a Circular Anal Dilator with Obturator and an Access Suture Anoscope. This set is commonly referred to by the product code STR5G.
The provided text describes a 510(k) summary for the CONTOUR® TRANSTAR™ Curved Cutter Stapler Set. It outlines the device description, indications for use, and a general statement about performance data. However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets specific criteria.
The relevant section {1} states: "Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device."
This statement is very broad and does not provide the detailed information requested in the prompt. Therefore, most of the questions cannot be answered from the provided text.
Here's a breakdown of what can be answered and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document only mentions "Bench testing and preclinical laboratory evaluations."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe the establishment of a "ground truth" using human experts for the conducted "bench testing and preclinical laboratory evaluations."
4. Adjudication method for the test set:
- Not applicable/Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical stapler, not an AI-powered diagnostic device, and thus an MRMC study with human readers comparing AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used:
- Not explicitly stated for the "bench testing and preclinical laboratory evaluations." For mechanical devices, "ground truth" would typically refer to engineering specifications, physical measurements, and histological analysis in preclinical studies. The document mentions these evaluations aimed to "demonstrate that the new device will perform as intended," implying performance against design specifications and intended function.
8. The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is a hardware device.
In summary: The provided 510(k) summary is for a medical device (surgical stapler) and predates widespread AI/ML software submissions. It focuses on demonstrating substantial equivalence to a predicate device through general performance testing (bench and preclinical) and a literature review, rather than the rigorous statistical study details often required for AI/ML devices outlined in your prompt. The document does not contain the detailed study information regarding acceptance criteria, sample sizes, expert involvement, or specific performance metrics that you requested.
§ 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.