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510(k) Data Aggregation
(79 days)
ACUFEX MICROSURGICAL, INC.
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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(38 days)
ACUFEX MICROSURGICAL, INC.
The Fast Pass Suture Punch System is indicated for the placement of sutures in Rotator Cuff and Bankart repair procedures. The Fast Pass Suture Punch System is intended to be used for the placement of sutures during arthroscopic and open procedures.
The Fast Pass Suture Punch System comprises three components: the Fast pass Suture Punch, the Fast Pass Suture Needle, and the Fast Pass Cannula/Obturator.
The provided text describes a medical device, the "Fast Pass Suture Punch System," and argues for its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission.
Instead, the provided text describes a submission for a surgical instrument (a suture punch) and its components, focusing on demonstrating its similarity to existing, legally marketed devices. The "study" mentioned is a general statement about basic functionality in a simulated environment, not a robust performance study with statistical metrics.
Therefore, for aspects related to acceptance criteria, specific performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, the information is not available in the provided text.
Here's how to categorize the available information:
Acceptance Criteria and Study for the Fast Pass Suture Punch System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Expected for AI/ML device) | Reported Device Performance (as stated in the document) |
|---|---|
| Not specified in the document | "the suture punch and suture needle successfully passed suture through a simulated tissue model." |
| No specific quantitative metrics (e.g., accuracy, sensitivity, specificity, AUC, F1-score) are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The phrase "a simulated tissue model" suggests a qualitative functional test rather than a structured test set with a specific sample size.
- Data Provenance: The test was conducted using "a simulated tissue model," so it's a bench test, not clinical data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for "successfully passed suture through a simulated tissue model" would likely be a direct observation of function, not expert consensus on diagnostic image interpretation. No experts are mentioned in relation to this test.
4. Adjudication method for the test set
- Not applicable. No complex ground truth establishment requiring adjudication is described.
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 submission is for a physical surgical instrument, not an AI/ML-driven diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This device is a physical instrument directly manipulated by a surgeon.
7. The type of ground truth used
- The "ground truth" for the simulated tissue model test was likely a direct observation of the mechanical function (i.e., whether the suture successfully passed through the simulated tissue), corresponding to a functional test or a "pass/fail" outcome for the mechanical action.
8. The sample size for the training set
- Not applicable. This device is a physical instrument, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
Summary regarding the provided text:
The document focuses on demonstrating substantial equivalence for a surgical instrument by comparing its components, materials, intended use, and indications to existing predicate devices. The "testing" mentioned is a basic functional check ("successfully passed suture through a simulated tissue model") to confirm suitability for its intended use, which is a common requirement for physical devices. It does not provide the kind of detailed performance study data (with acceptance criteria, sample sizes, expert ground truth, etc.) that would be expected for an AI/ML-driven medical device.
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(157 days)
ACUFEX MICROSURGICAL, INC.
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(252 days)
ACUFEX MICROSURGICAL, INC.
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