(58 days)
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
The SpeedStitch System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The needle cassette and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
The provided text describes a 510(k) premarket notification for the "SpeedStitch Suture Passer System." This is a medical device submission, and the information primarily focuses on demonstrating substantial equivalence to predicate devices through design verification and non-clinical testing. It does not involve a study proving the device meets acceptance criteria in the way this request implies (e.g., clinical trials with specific performance metrics like sensitivity, specificity, or reader agreement).
However, I can extract the relevant information regarding design verification and non-clinical testing that serves as the "study" proving the device meets its design specifications, which are a form of acceptance criteria in this context.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical performance targets and reported values. Instead, it broadly states that "Design Verification testing was performed in order to verify the design outputs meet the design inputs" and "The test results demonstrate that the proposed SpeedStitch meets its design, performance, and safety specifications."
The "acceptance criteria" here are implied to be the successful fulfillment of design inputs and performance specifications during bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Verify design outputs meet design inputs | Design Verification testing was performed. Test results demonstrate the proposed SpeedStitch meets its design, performance, and safety specifications. |
| Grasping of tissue model with suture passer | Successfully performed in in vitro testing. |
| Insertion of needles through tissue model | Successfully performed in in vitro testing. |
| Capturing suture from suture cartridges | Successfully performed in in vitro testing. |
| Suture successfully pulled through tissue model using suture passer | Successfully performed in in vitro testing. |
| Affirm safety and effectiveness during simulated use | Simulated use testing was performed on the device and accessory devices (suture cartridges). Test results demonstrate the proposed SpeedStitch performs as intended and mechanical properties are substantially equivalent to the predicate device. |
| Performance as intended | All testing demonstrates that the proposed SpeedStitch performs as intended and has acceptable performance when used in accordance with the labeling. |
| Mechanical properties substantially equivalent to predicate device | Test results demonstrate mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling. |
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 explicitly stated. The document mentions "bench testing," "in vitro testing," and "simulated use testing," but does not quantify the number of devices, tests, or tissue models used.
- Data Provenance: The testing was "in vitro" (bench testing) and "simulated use testing." This implies laboratory testing rather than real-world clinical data. There is no mention of country of origin as it's a non-clinical submission. The testing would be considered prospective for the specific tests performed as they were conducted to support this submission.
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)
Not applicable. This was a non-clinical device submission relying on engineering and performance testing. There was no "ground truth" derived from expert interpretation of data like in an AI/diagnostic device context. The "ground truth" for these tests would be the established design specifications and performance parameters measured by engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was mentioned or would typically be used for this type of non-clinical device testing. Performance was assessed against predefined engineering specifications.
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 device is a surgical instrument (suture passer), not a diagnostic or AI-assisted system for human interpretation. The submission explicitly states: "No clinical or animal data are included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "test set" (bench and simulated use testing), the "ground truth" was the design specifications and performance requirements established for the device. These tests aimed to verify that the device's actual performance met these predetermined engineering and functional requirements.
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not a learning algorithm or AI system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As no training set was used, no ground truth needed to be established for it.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.