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510(k) Data Aggregation
(32 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The CONMED Paradigm™ All-Suture Anchor manufactured from High Strength Flat Braided Suture, co-braided with a nylon monofilament, and threaded with one #2 (5 metric) Hi-Fi® suture strand. The ParadigmTM All-Suture Anchor is provided single-use, sterile, and preloaded on disposable driver. The anchor, suture, and disposable driver are EO Sterilized.
The provided text is a 510(k) summary for the CONMED Paradigm™ All-Suture Anchor. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
It does not contain information related to an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for diagnostic/prognostic tasks. Instead, it describes a medical device (a surgical anchor) and its equivalence to existing predicate devices based on material, design, intended use, and performance data relevant to its mechanical and biological properties.
Therefore, I cannot extract the information required to answer your prompt, such as:
- Acceptance Criteria Table and Reported Performance: The document lists "Verification Testing" and "Validation Testing" categories for the physical device, such as Reliability, Ultimate Fixation Strength, Biocompatibility, and Shelf-life. It states "Testing has been completed to demonstrate that the Paradigm™ All-Suture Anchor performs as intended and is substantially equivalent to the predicate device" and that "Bacterial endotoxin testing was conducted and met the endotoxin limits." However, it does not provide specific numerical acceptance criteria or performance numbers (e.g., a required tensile strength in N and the achieved tensile strength for the device).
- Sample size for test set and data provenance: Not applicable to this type of device.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of diagnostic performance. The "ground truth" for this device would relate to its structural integrity, biocompatibility, and similar physical/chemical properties, which are confirmed through engineering and biological testing.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In summary, the document describes the substantial equivalence of a physical medical device (a surgical suture anchor) to a predicate device, focusing on material, mechanical, and biological properties, not on an AI/ML algorithm's diagnostic performance. Therefore, the requested information elements related to AI/ML study design are not present in this text.
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(123 days)
Intended Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
Indications for Use
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The CONMED TruShot™ with Y-Knot® Shallow All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one #0 (3.5 metric) or one #2-0 (3 metric) Hi-Fi® suture strand with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.
The provided document is a 510(k) Summary for a medical device (TruShot™ with Y-Knot® Shallow All-Suture Anchor) and describes performance data to demonstrate substantial equivalence to a predicate device, rather than defining acceptance criteria and a study to prove a device meets those acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design for proving it, and specifics related to AI/algorithm performance (like effect size with AI assistance, standalone performance, training set details) are not applicable or extractable from this type of regulatory submission.
However, I can extract information about the types of performance testing conducted to support the device's clearance.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed reported device performance values. It states that "Testing has been completed to demonstrate that the TruShot™ with Y-Knot® Shallow All-Suture Anchor performs as intended and is substantially equivalent to the predicate device." It also mentions "met the endotoxin limits" without specifying the limit itself.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Sterilization | Met requirements |
| Pyrogen (Bacterial Endotoxin) | Met the endotoxin limits |
| Reliability (e.g., Ultimate Fixation Strength) | Performs as intended, substantially equivalent to predicate |
| Cyclic Testing | Performed side-by-side with predicate, results support SE |
| User Validation | Met requirements |
| Packaging | Met requirements |
| Transportation | Met requirements |
| Biocompatibility | Met requirements |
| Shelf-life | Met requirements |
| Post Aging Functional Testing | Met requirements |
| MR Safety Testing | Met requirements |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective nature, as these tests are typically bench or lab-based for medical devices like suture anchors.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical medical implant, not an AI or diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for this type of device testing.
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 such study was done or is relevant to this physical medical device. This is typically applicable to diagnostic AI devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance was done. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical and material properties (e.g., Ultimate Fixation Strength, Cyclic testing), the "ground truth" would be established by validated test methods and physical measurements, compared against established standards or performance of the predicate device. For biological tests (e.g., pyrogen, biocompatibility, sterilization), it would be against regulatory limits and specified testing standards.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
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(103 days)
Intended Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
Indications for Use
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The CONMED TruShot™ with Y-Knot® All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one or two #2 (5 metric) Hi-Fi® suture strands with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized.
The provided text describes a 510(k) premarket notification for a medical device called "TruShot™ with Y-Knot® All-Suture Anchor". It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for an AI/device algorithm in the way your request specifies.
The document discusses performance data in the context of device safety and efficacy and substantial equivalence to a predicate device, not in the terms of a novel AI algorithm's performance. Therefore, many of the requested elements (sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone AI performance, training set size, and ground truth establishment for training set) are not applicable or extractable from this document.
However, I can extract the general acceptance criteria (testing types) and a general statement about device performance.
Here's the information that can be extracted from the provided text, recognizing the limitations of the document relative to your detailed request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Testing Category) | Reported Device Performance |
|---|---|
| Reliability | Performed as intended |
| Ultimate Fixation Strength | Performed as intended |
| Cyclic | Performed as intended |
| Sterilization | Performed as intended |
| Pyrogen (Bacterial endotoxin testing) | Met the endotoxin limits |
| Biocompatibility | Performed as intended |
| Shelf-life | Performed as intended |
| Post Aging Functional Testing | Performed as intended |
| MR Safety Testing | Performed as intended |
| User Validation | Performed as intended |
| Packaging | Performed as intended |
| Transportation | Performed as intended |
2. Sample size used for the test set and the data provenance
Not explicitly stated for specific tests. The document refers to "testing" in a general sense, not specific to a "test set" for an algorithm. This is a traditional medical device submission, not an AI/ML submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. "User Validation" is mentioned, implying human interaction, but details on the number or qualifications of users/experts involved in this validation are absent.
4. Adjudication method for the test set
Not applicable based on the provided document.
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 device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For a traditional medical device like a suture anchor, "ground truth" would typically refer to established biomechanical properties, material standards, and clinical outcomes for similar devices. The document implies compliance with these through the various verification and validation tests listed. Pathology or outcome data are not specified as direct ground truth for these tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and thus no "training set" in that context is mentioned.
9. How the ground truth for the training set was established
Not applicable.
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