(90 days)
The Bionx Bankart Tack is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions). When used in conjunction with appropriate postoperative immobilization, the Bionx Bankart Tack provides secure tissue stabilization throughout the healing period.
The Bankart Tack is a cannulated tack with a round head and four circumferential rows of scaled edges along the distal end to securely fix the tack in the bone.
The provided text does not contain detailed information about specific acceptance criteria, comprehensive study designs, or detailed performance results that would allow for the complete filling of the requested table and study information. The document is a 510(k) summary for a medical device which focuses on demonstrating substantial equivalence to predicate devices, rather than providing an in-depth clinical trial report.
However, based on the available information, I can infer some aspects and highlight what is missing.
Analysis of the Provided Text:
The document states: "Additionally, performance testing and clinical studies have demonstrated that the insertion technique for the Bionx Bankart Tack provides adequate fixation for this intended use." and "Both the PLLA and polyglyconate materials are biocompatible and possess sufficient strength for this intended use, as demonstrated in clinical studies and performance testing." and "The minor differences in the technical characteristics of the devices do not raise new questions of safety or effectiveness, as confirmed by performance testing and clinical studies."
These statements indicate that some form of performance testing and clinical studies were conducted and confirmed adequate fixation, biocompatibility, and sufficient strength. However, the document does not detail these studies' methodologies, sample sizes, specific acceptance criteria, or precise performance outcomes. It primarily asserts that these studies support the substantial equivalence claim.
Inferences and Missing Information Summary:
- Acceptance Criteria and Reported Device Performance: The document generally states "adequate fixation," "sufficient strength," and "biocompatible" as performance goals, implying these were the de facto acceptance criteria. However, no specific numerical thresholds or metrics are provided.
- Sample Size and Data Provenance (Test Set): Not mentioned.
- Number and Qualifications of Experts (Ground Truth): Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned as a component for this 510(k) submission. 510(k)s typically focus on equivalence to existing devices rather than comparative effectiveness studies against unassisted human performance, especially for a physical implant.
- Stand-alone Performance Study: The "performance testing and clinical studies" mentioned would likely involve standalone performance evaluation of the device's mechanical integrity, fixation strength, and biocompatibility, but details are not provided.
- Type of Ground Truth: For a physical implant, "ground truth" would typically refer to objective measurements of mechanical properties (e.g., pull-out strength, degradation rate) from performance testing and clinical outcomes (e.g., successful reattachment, lack of adverse events) from clinical studies. The specific methods for establishing these are not detailed.
- Training Set Sample Size: Not applicable since this is a physical device, not an AI/ML algorithm that requires a training set in the conventional sense.
- Ground Truth for Training Set: Not applicable.
Based on the provided document, here is the most accurate response to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Adequate tissue fixation | Demonstrated adequate fixation |
| Sufficient mechanical strength | Possesses sufficient strength |
| Biocompatibility | Demonstrated biocompatibility |
| No new safety/effectiveness issues compared to predicates | Minor differences do not raise new issues |
Note: The document states that performance testing and clinical studies demonstrated these, but does not provide specific quantitative acceptance thresholds or detailed performance metrics.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The document only generally refers to "performance testing and clinical studies."
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 text. For a physical implant, "experts" in establishing ground truth would typically refer to surgeons or pathologists involved in clinical assessments, or engineers/scientists performing laboratory tests. Their specific roles or numbers are not mentioned.
4. Adjudication Method for the Test Set:
- Not applicable/mentioned. Adjudication methods like 2+1 or 3+1 are common in studies involving subjective interpretation (e.g., imaging reads by multiple radiologists) where expert consensus is needed. This document pertains to a physical implant where the "ground truth" would be more objective (e.g., mechanical test results, clinical outcomes).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study is not mentioned or implied by the document. This type of study is more relevant for diagnostic imaging AI devices where human readers' performance with and without AI assistance is compared. The Bionx Bankart Tack is a physical implant.
6. If a Standalone Performance Study was done:
- Yes, implicitly. The document states "performance testing and clinical studies have demonstrated..." This suggests standalone evaluations were conducted to assess the device's mechanical, material, and functional properties independent of direct human-AI interaction comparisons. However, the details of these standalone studies (methodology, results) are not provided.
7. The Type of Ground Truth Used:
- For the performance testing, the ground truth would likely be based on:
- Objective Measurements: Mechanical properties (e.g., pull-out strength from bone, degradation rate) assessed in laboratory settings.
- Biocompatibility Assessments: Standardized tests for material interaction with biological systems.
- For clinical studies, the ground truth would likely be based on:
- Clinical Outcomes Data: Successful tissue reattachment, stability of the joint, absence of complications, healing assessed through follow-up examinations (e.g., imaging, physical exams).
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this physical device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.