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510(k) Data Aggregation
(112 days)
Bioabsorbable Anchor
The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.
The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone (PDO) dyed with D&C Violet No. 2. Two Bioabsorbable Anchors are provided sterile for single use only, packaged preloaded in a disposable anchor inserter instrument, the Dual Anchor Inserter. The preloaded Dual Anchor Inserter is provided in a dual sterile pouch confiquration.
The provided text discusses a 510(k) premarket notification for a medical device called the "Bioabsorbable Anchor." It details the device's description, indications for use, comparison to a predicate device, and performance data required for substantial equivalence determination.
However, the document does not contain information regarding the acceptance criteria and study proving the device meets those criteria in the context of an AI/human-in-the-loop setting, as implied by the detailed questions about sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance.
The "Performance Data" section of the document specifically outlines:
- Biocompatibility Testing: Conducted in accordance with ISO 10993 standards.
- Non-Clinical Performance Testing: Included insertion, pullout, and fatigue testing, evaluated in comparison to the predicate device and guided by FDA guidance for "Bone Anchors."
- In vitro hydrolytic degradation study: Guided by ASTM F1635-16.
- Absorption Profile: Describes the hydrolytic degradation and tissue response after 13 weeks.
These tests are primarily mechanical, material, and biological evaluations relevant to the physical performance and safety of an implantable device, not an AI/software device that requires extensive clinical validation with human readers or standalone algorithm performance metrics like sensitivity, specificity, or AUC based on expert ground truth.
Therefore, I cannot extract the information required to answer your specific questions from the provided text as it pertains to a different type of medical device evaluation.
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(79 days)
ACUFEX TAG BIOABSORBABLE ANCHORS
The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue.
Indications The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors statement are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow.
The Acufex TAG Bioabsorbable Anchors are wedge-and rod shaped, sterile suture anchors, with a hole through which suture is threaded. the tag anchors are implanted into bone, burying and anchoring the implant and attached suture, which can be used to reattach and secure soft tissue, such as ligaments and tendons. Three sizes of the devices will be used in the foot, ankle and elbow applications, the Tag 3.7mm Wedge and Rod II and 3.0mm and 2.0mm Wedge Anchors.
The provided document describes the safety and effectiveness information for the Acufex® TAG and Mini-TAG Bioabsorbable Anchors. It does not contain information related to AI/ML device performance or a study design as typically seen for such devices. Instead, it presents performance data for a medical implant (suture anchors). Therefore, I cannot provide the requested information in the typical format for an AI/ML device.
However, I can extract the acceptance criteria and performance data for the bioabsorbable anchors based on the provided text, reinterpreting the request for a hardware medical device.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a bioabsorbable anchor, "acceptance criteria" are typically defined by engineering specifications and functional performance benchmarks to ensure safety and effectiveness. "Reported device performance" refers to the results of testing against these benchmarks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: | |
| Pull-out strength equivalent to commercially available TAG Anchors (non-absorbable). | Pull-out strength of the TAG Bioabsorbable Anchors is equivalent to that of the commercially available TAG Anchors when directly compared in cadaveric bones of the tibia (a worst-case model). |
| Pull-out strength greater than or equivalent to "worst-case" clinical loads for specified surgical indications. | Pull-out strength of the TAG Bioabsorbable Anchors is greater than or equivalent to the "worst-case" clinical loads encountered by the anchors in the specified surgical indications. |
| Bridge strength significantly greater than the largest sutures intended for use. | Bridge strength of the TAG Bioabsorbable Anchors is significantly greater than the largest size sutures intended for use with the anchors. |
| Pull-out strength of smallest sutures greater than or equivalent to "worst-case" clinical loads. | Pull-out strength of the smallest size sutures intended for use with the TAG Bioabsorbable Anchors is greater than or equivalent to the "worst-case" clinical loads encountered by the anchors in the specified surgical indications. |
| Clinical Relevance/Safety: | |
| "Worst-case" clinical loads for new indications (foot, ankle, elbow) are lower than currently cleared indications (e.g., shoulder instability). | The "worst-case" clinical loads encountered by the anchors in the specified indications (foot, ankle, elbow) are lower than those encountered in the treatment of shoulder instability, one of the currently cleared indications for use (K946346). |
| Pull-out strength equivalent to commercially available Mitek Mini-GII Anchors. | Pull-out strength of the TAG Bioabsorbable Anchors is equivalent to that of the commercially available Mitek Mini-GII Anchors and TAG Anchors. The Mitek Mini-GII Anchors and the TAG Anchors were directly compared in cadaveric bones of the tibia (worst case), foot, ankle, and elbow. |
| Repair strengths using bioabsorbable anchors in foot and ankle equivalent to standard suture repair techniques. | Repair strengths using the TAG Bioabsorbable Anchors in the foot and ankle are equivalent to standard suture repair techniques for the same soft tissue repairs. |
2. Sample size used for the test set and the data provenance
The document mentions "cadaveric bones of the tibia" and "cadaveric bones of the tibia (worst case), foot, ankle, and elbow" for pull-out strength comparisons. However, the specific sample sizes (number of cadavers, number of tests per cadaver, etc.) are not provided in this summary.
The provenance of the data is implicitly retrospective experimental testing conducted in a lab setting, likely using cadaveric human or animal tissue. The country of origin for the data is not specified, but the submitter (Smith & Nephew Endoscopy, Inc.) is based in Massachusetts, U.S.A.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here as the device is a medical implant, not an AI/ML diagnostic tool. Ground truth would be based on direct physical measurements of mechanical properties, not expert interpretation of visual data.
4. Adjudication method for the test set
Not applicable for mechanical testing of a medical implant as described. Results are quantitative measurements.
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
Not applicable. This is not an AI/ML diagnostic device study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML diagnostic device study.
7. The type of ground truth used
For the safety and effectiveness claims, the "ground truth" for the mechanical performance was established through direct physical measurement of mechanical properties such as pull-out strength and bridge strength, performed on cadaveric bone models. The "worst-case" clinical loads serve as a benchmark derived from clinical understanding.
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML training set. The "training" here would be the design iterations and preliminary testing during product development.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML training set.
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