(90 days)
The BioStinger™ Bioabsorbable Implant provides fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.
The BioStinger™ Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid, and will gradually be absorbed into the body. The implant is colored with D&C Violet #2. The implant is preloaded on a single-patient use, sterile, disposable, re-loadable inserter. The implant is radiotranslucent with regard to intraoperative fluoroscopy, but it can be visualized with MRI and CAT scan.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pre-Loaded BioStinger Hornet™:
Acceptance Criteria and Device Performance Study (Pre-Loaded BioStinger Hornet™)
Summary: The provided documentation focuses on establishing substantial equivalence for the Pre-Loaded BioStinger Hornet™ to a predicate device, the BioStinger-V™. The key finding is that the act of pre-loading the implant does not introduce new safety or effectiveness concerns, indicating that its performance is comparable to an already approved device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (relative to predicate device, BioStinger-V™) | "Performance testing has been conducted to show that pre-loading the implant does not raise any new issues regarding safety and effectiveness." (Implies comparable safety and effectiveness to the predicate device) |
| Design Equivalence | The device is "substantially equivalent in design" to the BioStinger-V™. |
| Technology Equivalence | The device is "substantially equivalent in... technology" to the BioStinger-V™. |
| Intended Use Equivalence | The device is "substantially equivalent in... intended use" to the BioStinger-V™. The intended use is "fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Performance testing," but does not provide details on the number of devices or experimental conditions used in distinguishing the "Pre-Loaded BioStinger Hornet™" from the "BioStinger-V™."
- Data Provenance: Not explicitly stated. The document indicates that Linvatec Corporation conducted the testing (a US-based company), but no geographic origin of the specific test data or whether it was retrospective or prospective is mentioned.
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 given text. The document describes engineering/performance testing rather than clinical trials requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. The assessment appears to be based on direct functional performance testing, not on subjective expert review or a consensus process for case adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document describes engineering performance testing to demonstrate substantial equivalence, not a clinical study involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
- For the performance testing mentioned, the "ground truth" would likely be objective engineering measurements and criteria related to the physical and mechanical properties of the device (e.g., fixation strength, biodegradation rate, ease of deployment, impact of pre-loading on mechanical integrity). The document asserts that "pre-loading the implant does not raise any new issues regarding safety and effectiveness," implying that the measured performance met pre-determined safety and effectiveness benchmarks, which would constitute the "ground truth" for this engineering assessment.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical implant, not an AI model, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI/algorithm-based device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.