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510(k) Data Aggregation
(29 days)
ArthoCare Corporation
The MultiFIX S Ultra Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The MultiFIX S Ultra Knotless Fixation System (MultiFIX S Ultra) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S Ultra is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S Ultra consists of two primary parts: an implantable bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
The provided text describes the MultiFIX® S Ultra Knotless Fixation System, a bone anchor device, and its substantial equivalence to a predicate device. This submission is for a medical device that requires mechanical and functional testing, not an AI/ML powered device, therefore some of the requested information (such as reader studies, ground truth for AI, training set size) is not applicable.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical values for performance. Instead, it states that "The test results demonstrate that the proposed MultiFIX S Ultra meets its design, performance, and safety specifications." and "All testing demonstrates that the proposed MultiFIX S Ultra performs as intended and has acceptable mechanical properties when used in accordance with the labeling."
The bench testing was performed "in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996." This guidance likely outlines the types of tests and expected performance metrics for bone anchors, which would serve as the acceptance criteria. The performance is reported as meeting these implied specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet design, performance, and safety specifications (per FDA Guidance Document, Testing Bone Anchors, April 1996) | "The test results demonstrate that the proposed MultiFIX S Ultra meets its design, performance, and safety specifications." |
| Acceptable mechanical properties | "All testing demonstrates that the proposed MultiFIX S Ultra performs as intended and has acceptable mechanical properties..." |
| Substantially equivalent mechanical properties to predicate device | "...mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling." |
2. Sample size used for the test set and the data provenance
The document states that "Bench testing was performed on both the proposed and predicate devices" for static and cyclic fatigue testing, and also "Design Verification testing" and "Simulated use testing." However, the exact sample sizes for these tests are not explicitly provided in the document.
Data provenance:
The data is from non-clinical bench testing. The tests simulate human bone substrate. No specific country of origin for the data is mentioned, but it's part of a submission to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a physical medical device, not an AI/ML powered device where expert consensus for ground truth is typically required. The "ground truth" for this type of device is established through engineering and material science principles, against defined performance specifications and physical testing methods.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations. The testing involves objective physical measurements and comparisons to engineering specifications and predicate device performance.
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 device is a bone anchor, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical bone anchor, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and comparative mechanical testing results against a predicate device, as well as adherence to the principles outlined in the "FDA Guidance Document, Testing Bone Anchors, April 1996."
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
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(94 days)
ARTHOCARE CORPORATION
The MultiFIX S Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia: extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The MultiFIX S Knotless Fixation Device (MultiFIX S) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S consists of two primary parts: a PEEK bone anchor inserter. which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
The MultiFIX S Knotless Fixation System consists of the bone anchor and associated instruments for implanting the bone anchor.
The provided document describes the MultiFIX® S Knotless Fixation Device and its 510(k) submission, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.
However, I can extract information regarding the device's acceptance criteria and the study that proves it meets them, based on the document's content.
Acceptance Criteria and Device Performance for MultiFIX® S Knotless Fixation Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Metric) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Properties | Deemed substantially equivalent to predicate devices. Meets design, performance, and safety specifications. Performs as intended. |
| Design Specifications | Met |
| Performance Specifications | Met |
| Safety Specifications | Met |
| Substantial Equivalence | Demonstrated across intended use, operating principle, materials, and technological characteristics when compared to predicate devices. Minor differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It mentions that "Bench testing was performed on both the proposed and predicate devices," indicating that multiple units of each were tested.
- Data Provenance: The testing was "in vitro," using a "simulated human bone substrate." This indicates the data is from a controlled lab environment (bench testing), not from human or animal subjects. The country of origin is not explicitly stated but implies the US, given the submission to the FDA. The testing is prospective as it's part of the premarket submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the study involves mechanical bench testing of a device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" here is the physical performance measured against engineering specifications.
4. Adjudication method for the test set
- This question is not applicable for the same reasons as above. No expert adjudication method (like 2+1 or 3+1) is relevant for mechanical bench 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
- This question is not applicable. This submission is for a medical device (bone anchor), not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This involves a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing was based on pre-defined design, performance, and safety specifications, and comparison to the mechanical properties of legally marketed predicate devices. This is an engineering/design-based ground truth, not clinical or diagnostic.
8. The sample size for the training set
- This question is not applicable as there is no AI/ML algorithm involved. The device underwent bench testing, not a training process.
9. How the ground truth for the training set was established
- This question is not applicable as there is no AI/ML algorithm involved.
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(271 days)
ARTHOCARE CORPORATION
The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including: Ablation and Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), and Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons). These procedures are applicable to specific joints or all joints (ankle, elbow, hip, knee, shoulder, and wrist).
The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosurgical device which consists of a distal electrode tip composed of tungsten and titanium, a ceramic spacer-cap, a stainless steel shaft, internal suction tubing, and a molded handle with integrated finger switches. The Ambient TurboFlash 90 IFS is only compatible with the Quantum™ 2 Controller which incorporates a "Use Limiting" feature that prevents the re-use of the device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ArthroCare Ambient® TurboFlash™ 90 IFS Wand:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes modifications to an existing predicate device and focuses on establishing substantial equivalence through non-clinical performance testing. It does not explicitly define quantitative "acceptance criteria" in the traditional sense (e.g., "sensitivity must be > X%") or report quantitative "device performance" metrics against such criteria in a table format. Instead, the "acceptance criteria" are implied by successful completion of various tests demonstrating equivalence or improved characteristics without adverse effects.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Ablation and Coagulation Performance Equivalence | "Ablation and coagulation testing" successfully evaluated the device, demonstrating that proposed modifications "do not affect the safety or efficacy of the device." The rationale for design changes (e.g., smaller profile tip) also implies that performance in these areas should be maintained or improved for surgical access. |
| Electrical Safety Compliance | "Electrical safety testing including Hipot, continuity, and IEC 60601-2-2:2009" was successfully conducted, indicating compliance with relevant standards. |
| Tip Strength | "I Tip strength testing" was performed successfully. |
| Suction Rate | "Suction rate testing" was successfully performed. |
| Ex Vivo Performance | "Ex vivo performance testing" was successfully conducted. While specific metrics aren't provided, the conclusion is that the modifications "do not affect the safety or efficacy." |
| Ambient Temperature Measurement | "Ambient temperature measurement testing" was successfully performed. |
| Manufacturing Efficiency and Surgical Access (Improved) | The one-piece spacer-cap and revised screen securing method were proposed to "Facilitates the manufacturability of a smaller profile tip which provides the surgeon better access to tight joint spaces" and "more efficient manufacturability; and a smaller profile tip to provide surgical access to tight joint spaces." This is an improvement over the predicate, not a maintained criterion. |
| Therapy Delivery Flexibility (Improved) | The resistor change allowing a maximum ablation set point of 10 (vs. 9 in predicate) "Provides the surgeon more flexibility in delivering therapy." This is an improvement over the predicate, not a maintained criterion. |
| Substantial Equivalence to Predicate Device (Overall) | The overall conclusion of the non-clinical performance testing is that "This testing demonstrated that the proposed modifications for the Ambient TurboFlash 90 IFS are substantially equivalent and do not affect the safety or efficacy of the device" and that it "is substantially equivalent to the Ambient Super TurboVac 90 IFS cleared via K083306. Both the subject and the predicate devices have the same indications for use and utilize the same fundamental scientific technology. The proposed modifications are not substantial and do not significantly affect the safety or efficacy of the device." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes non-clinical bench testing and ex vivo performance testing. It does not mention a "test set" in the context of human subjects or clinical data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable to this type of submission. The data provenance would be laboratory testing conducted by the manufacturer, ArthroCare Corporation, based in Austin, Texas.
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 as the submission is based on non-clinical bench and ex vivo testing, not on clinical data requiring expert review for ground truth establishment.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set:
This information is not applicable for the same reasons as #3.
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:
This information is not applicable. This submission is for an electrosurgical device, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies or AI assistance for human readers are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is established through objective engineering and performance testing standards and measurements. This includes:
- Engineering specifications and design verification.
- Conformity to recognized electrical safety standards (e.g., IEC 60601-2-2:2009).
- Quantitative measurements in ablation, coagulation, tip strength, suction rate, and temperature.
- Ex vivo performance assessments against expected functional outcomes.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI/machine learning device that requires a training set. The device design and performance are based on engineering principles and established medical device development processes, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
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(19 days)
ARTHOCARE CORPORATION
The SmartStitch® PerfectPasser® System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
The SmartStitch PerfectPasser System is a Class II device consisting of the following components: SmartStitch® PerfectPasser® Connector, SmartStitch® Handle, Suture Cartridge containing Suture.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for testing, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or details about training sets. The document is primarily a regulatory submission letter for a medical device (SmartStitch® PerfectPasser® System) and includes general information about the device and its intended use. Therefore, I cannot fulfill your request for that specific information based on the input provided.
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(72 days)
ARTHOCARE CORPORATION
The SmartStitch® M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers. The handle is provided non-sterile. The connector and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
The provided text describes a 510(k) summary for the ArthroCare SmartStitch M-Connector Ultra System. This is a medical device, and the submission clarifies that no clinical or animal data were included in the submission. The device's substantial equivalence to predicate devices was demonstrated solely through non-clinical bench testing.
Therefore, most of the requested information for acceptance criteria and study details related to human performance, such as sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, is not applicable to this particular 510(k) submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the SmartStitch M-Connector Ultra System meets all design, performance, and safety specifications."
However, specific numerical acceptance criteria (e.g., tensile strength thresholds, penetration force ranges) and their corresponding reported values are not detailed in this summary. The summary only provides a general statement of compliance.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meet all design specifications | Met |
| Meet all performance specifications | Met |
| Meet all safety specifications | Met |
| Perform as intended | Performed as intended |
| Acceptable mechanical properties | Acceptable |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for non-clinical bench testing.
- Data Provenance: Non-clinical bench testing, conducted by the manufacturer (ArthroCare Corporation). Not applicable for country of origin or retrospective/prospective in the context of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical data or human expert evaluation was used for this submission. Ground truth for bench testing would be defined by engineering specifications and material properties.
4. Adjudication method for the test set
Not applicable, as no clinical data or human expert evaluation was used. Adjudication methods are typically relevant for subjective human assessments.
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 performed as no clinical data, AI, or human reader evaluations were part of this submission. The device is a manual arthroscopic instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. A standalone algorithm performance study was not performed as the device is a manual medical instrument and does not involve an algorithm.
7. The type of ground truth used
For the non-clinical bench testing, the ground truth would have been established by engineering specifications, material standards, and validated testing methodologies to assess the physical and mechanical properties of the device (tensile strength, durability, needle penetration, suture delivery mechanisms, etc.).
8. The sample size for the training set
Not applicable, as no machine learning or AI component is mentioned or relevant to this device. Bench testing does not involve training sets in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML model.
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(65 days)
ARTHOCARE CORPORATION
The Endoflip graft fixation device is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
Endoflip graft fixation device for femoral fixation of hamstrings grafts in cruciate ligament reconstruction.
I am sorry, but the provided text is a heavily redacted FDA document that does not contain information regarding acceptance criteria, study details, or performance data for the "Endoflip" device. The document is primarily a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to a predicate device and outlining regulatory responsibilities.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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