(169 days)
The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures.
The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.
This document is a 510(k) Pre-market Notification from the FDA for the PROXISURE Suturing Device and its associated Suture Cartridges. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable or cannot be extracted from this type of regulatory document.
However, I can provide information based on the performance data presented in the summary, which states that bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Needle passing reliability (e.g., successful needle passing rate) | Bench testing demonstrated performance meeting substantial equivalence. |
| Needle passing and tissue sticking (e.g., absence of sticking) | Bench testing demonstrated performance meeting substantial equivalence. |
| Knot strength (e.g., strength comparable to predicate) | Bench testing demonstrated performance meeting substantial equivalence. |
| Needle pull-off strength (e.g., strength comparable to predicate) | Bench testing demonstrated performance meeting substantial equivalence. |
| Suture manipulation needle release (e.g., proper release mechanism) | Bench testing demonstrated performance meeting substantial equivalence. |
| Cartridge cage pullback (e.g., proper function of pullback) | Bench testing demonstrated performance meeting substantial equivalence. |
| Needle release force (e.g., force within acceptable range) | Bench testing demonstrated performance meeting substantial equivalence. |
| End effector features testing (e.g., proper articulation/rotation) | Bench testing demonstrated performance meeting substantial equivalence. |
Explanation: The document does not provide specific quantitative acceptance criteria or detailed quantitative results. Instead, it states that
Bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.
This implies that the acceptance criteria were based on demonstrating comparable performance to the predicate device in these specific areas.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "bench testing."
- Data Provenance: Not specified, but generally, bench testing is conducted in a laboratory setting, not typically tied to a specific country of origin in the same way clinical data would be. It is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this document. The "ground truth" concept is more relevant for diagnostic or AI devices where a definitive expert-determined label or outcome is needed. For mechanical device bench testing, "ground truth" is typically defined by engineering specifications and objective measurements, not subjective expert assessment of an outcome in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable to this document. Adjudication methods are used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Bench testing of a mechanical device does not typically involve such 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
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant to a mechanical suturing device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to this document. This refers to the standalone performance of an AI algorithm. The PROXISURE Suturing Device is a mechanical device, not an AI or algorithm. The "bench testing" described is for the mechanical function of the device, which is its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the bench testing described, the "ground truth" would be established by engineering specifications, material science properties, and objective physical measurements against predefined performance standards or in comparison to the predicate device's measured performance. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
- Not applicable. This device is a mechanical suturing device, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.