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510(k) Data Aggregation
(21 days)
The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)
The Arthrex Double Loaded Knotless FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.
The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.
Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.
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(216 days)
The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs, including those with allograft tissues, are used for repair.
The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.
The provided document is a 510(k) summary for the Arthrex BioSuture, a surgical suture. It details the device's indications for use, technological characteristics, and conformity to established standards through performance testing. However, the document does not describe a study involving an AI/ML device, human readers, or any of the specific criteria typically associated with such studies (e.g., sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set details).
This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (suture) through mechanical testing and comparison of attributes.
Therefore, most of the requested information regarding AI/ML device acceptance criteria and studies cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested against) | Reported Device Performance (Arthrex BioSuture) |
|---|---|
| Strength of the proposed Arthrex BioSuture met the established acceptance criteria (implicitly, this refers to the strength of predicate devices for comparison) | Mechanical testing (straight pull, knot pull) demonstrated that the strength of the proposed Arthrex BioSuture met the established acceptance criteria. |
| Pyrogen limit specifications (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14) | Bacterial Endotoxins Test (BET) was performed on representative samples utilizing the Kinetic Chromogenic Method to demonstrate that the proposed device meets pyrogen limit specifications. |
| Substantially equivalent to predicate devices (K112899, K140019) in terms of overall design, configuration, intended use/indications, surgical technique, fundamental scientific technology, sterility, materials, packaging, and manufacturing process. | The Arthrex BioSuture is substantially equivalent to the predicate devices with minor dimensional modifications and no change to intended use or function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "representative samples" for the Bacterial Endotoxins Test and generally mentions "mechanical testing."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML study involving human expert ground truth. The "ground truth" here is based on physical material properties and established industry standards for sutures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML study involving human expert ground truth adjudication.
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 document describes a submission for a surgical suture, not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical medical device (suture), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for comparison described in this document is based on:
- Established physical and mechanical properties of surgical sutures: Primarily tensile strength (straight pull, knot pull) as defined by internal acceptance criteria and implicitly compared to predicate devices.
- Regulatory standards: Specifically pyrogen limits as outlined in ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14.
- Characteristics of legally marketed predicate devices: For demonstrating substantial equivalence in design, materials, manufacturing, and performance.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
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(176 days)
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
The BioBrace™ implant is a bioresorbable, biocomposite scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 um filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm³, and median pore diameter of 19 µm. The highly-porous collagen sponge comprises the majority of implant surface area (0.7 m²/gram) versus the PLLA filaments alone (0.2 m²/gram), creating a large biologic matrix for cellular ingrowth. BioBrace implants are approximately 3 mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, and are designed for soft tissue and tendon augmentation and reinforcement. The BioBrace implant is single-use and supplied sterile with SAL of 10°.
The provided text describes the BioBrace™ Implant, a bioresorbable, biocomposite scaffold intended for reinforcement of soft tissue. The document focuses on demonstrating the substantial equivalence of the BioBrace™ Implant to a predicate device (STR GRAFT, K121216) and several reference devices rather than establishing novel acceptance criteria for a new type of device. Therefore, the information provided relates to testing parameters and comparable performance, rather than distinct acceptance criteria for the device's function as an AI or diagnostic tool.
The document does not describe a study involving an AI algorithm or human-in-the-loop performance, so many of the requested categories for AI-related studies are not applicable.
Here's the information extracted from the provided text, primarily focusing on the performance data and comparative studies as they relate to device safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with direct quantitative thresholds that the device had to meet to be proven effective in a standalone capacity. Instead, it details performance tests conducted and compares the results to predicate/reference devices or established biological norms. The implied acceptance criteria are that the BioBrace™ Implant performs equivalently to the predicate device and demonstrates acceptable biocompatibility, mechanical integrity, and biological response.
| Acceptance Criterion (Implied/Tested Aspect) | Reported Device Performance (BioBrace™ Implant) |
|---|---|
| Biocompatibility | No adverse biological response per chemistry, Toxicological Risk Assessment (TRA), and ISO 10993 assessments (Cytotoxicity, Local Implantation Effects, Irritation/Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogenicity). |
| In vivo ovine study showed "minimal to no reaction" per ISO10993-6 criteria, normal healing response, and no evidence of adverse reactions macroscopically, radiographically, or histologically. | |
| Mechanical Integrity (in vitro) | Fluid Uptake: >300% (measured gravimetrically, per ASTM F-2212), "significantly higher than FiberTape." |
| Mechanical Properties (various): Maintained through healing per in vitro testing at 37°C in PBS at 6, 12, and 26 weeks. Tested parameters included ultimate tensile strength, tear resistance strength, suture pull-through strength, ball burst strength (per ASTM standards D882-10, D226, D3787); PLLA polymer fiber properties (per ASTM D2857 and D3418); collagen, fluid uptake, and absorbance properties (per ASTM F2212). | |
| Mechanical Integrity (in vivo augmentation) | Pull-out strength (ovine extensor tendon): Statistically significant increase with BioBrace augmentation: 656 ± 87 N (with BioBrace) vs. 457 ± 70 N (without BioBrace). |
| Stiffness (ovine extensor tendon): Statistically significant increase with BioBrace augmentation: 175 ± 22 N/mm (with BioBrace) vs. 124 ± 29 N/mm (without BioBrace). | |
| Ultimate Tensile Strength (ovine rotator cuff repair): Increased from time-0 (1163 ± 303N) to 6-weeks (1740 ± 338N) and to 12-weeks (2463 ± 484N). | |
| No significant difference in UTS between BioBrace repaired tendons and contralateral native control tendons at 12-weeks (2463 ± 484N vs. 2707 ± 605N). | |
| Biological Response (in vivo) | Rapid tissue and cellular infiltration (6-weeks) in ovine model. |
| Low to no adverse tissue/cellular inflammation per ISO 10993-6 scoring. | |
| Normal healing response, progressive new tissue formation and integration, neovascularization, fibroblast activity, and new blood vessels at host/implant interface and within porous structure. Local tissue response included low numbers of macrophages and multinucleated giant cells with scattered lymphocytes. | |
| Sterilization | Validated to 10⁻⁶ SAL (Sterility Assurance Level) with ethylene oxide per ISO 14937:2009. Max EO residual limits met per ISO 10993-7:2008. |
| Endotoxin Levels | Met acceptance criteria of |
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(214 days)
The Arthrex SutureTape is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.
Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Arthrex SutureTape is packaged sterile for single use. New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR 74.3054.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Arthrex SutureTape." This document details the regulatory clearance for a surgical suture and focuses on demonstrating substantial equivalence to previously cleared devices.
Crucially, this document does not describe acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria. It pertains to a physical medical device (suture) and its mechanical and biocompatibility testing. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and study details for an AI/ML device.
The information you are asking for, such as sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, and training set details, are specific to the validation of AI/ML systems, particularly in medical imaging or diagnostic contexts. This document is about a surgical suture.
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(295 days)
The Arthrex FiberTape Cerclage suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:
- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- · Sternotomy indications including the "rewiring" of osteotomized sternums.
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
- · Repair of long bone fractures due to trauma or reconstruction.
The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.
The provided document is a 510(k) premarket notification for the Arthrex FiberTape Cerclage suture, seeking clearance for its use as a bone fixation cerclage. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and performance data from various studies.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance values for each criterion. Instead, it describes various tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Arthrex FiberTape Cerclage performs equivalently or acceptably compared to the cleared predicate devices.
However, based on the Substantial Equivalence Summary, we can infer the types of performance aspects evaluated:
| Performance Aspect (Implicit Acceptance Criterion) | Reported Device Performance |
|---|---|
| Fatigue Strength | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Tensile Force | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Creep | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Knot Strength | Demonstrated substantial equivalence to cleared DSM Biomedical DPR Cable and Kinamed ISO-Elastic Cerclage System. |
| Wear Testing with Particle Analysis | Demonstrated no statistical significant differences between the proposed Arthrex FiberTape Cerclage and the cleared DSM Biomedical DPR Cable. |
| Bacterial Endotoxins Test (Pyrogenicity) | Performed in accordance with USP and demonstrated that the device meets pyrogen limit specifications. (This implies it passed the limits set by USP ). |
| Biocompatibility | Not explicitly detailed in this section, but is generally required for medical devices. The document implies it's covered by substantial equivalence to predicates using similar materials. |
| Material Composition | Braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials, identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of units, number of tests) used for each of the performance tests (fatigue strength, tensile force, creep, knot strength, wear testing, bacterial endotoxins).
- Data Provenance: The studies appear to be pre-clinical, benchtop (in-vitro) studies conducted by the manufacturer (Arthrex Inc.) for the purpose of demonstrating substantial equivalence. There is no indication of country of origin for the data provided, nor whether it is retrospective or prospective, as these terms usually apply to clinical studies involving human or animal subjects. These are laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number of experts, qualifications) is not applicable to the studies described. The tests performed are mechanical and chemical characterizations of the device, not diagnostic or clinical assessment studies that would require expert interpretation to establish a ground truth. The "ground truth" here is objective measurement against defined physical or chemical properties and standards (e.g., tensile strength, presence of endotoxins).
4. Adjudication Method for the Test Set
This is not applicable as there are no "readers" or subjective interpretations requiring adjudication for the benchtop tests described. The 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
This is not applicable. The device is the "Arthrex FiberTape Cerclage suture," which is a physical surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. As stated in point 5, this is not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the tests performed is based on objective, quantifiable physical and chemical properties and established standards.
- For mechanical tests (fatigue, tensile, creep, knot strength, wear), the "ground truth" is the measured performance data compared against the performance of predicate devices and engineering specifications.
- For the Bacterial Endotoxins Test, the "ground truth" is compliance with the pyrogen limit specifications outlined in USP .
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is a physical product.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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(24 days)
SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissue are used for repair.
SutureTape is a braided suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends and has a width of 1.3 mm. SutureTape is available in precut lengths in straight and loop configurations, and with or without needles. SutureTape is packaged sterile for single use. SutureTape meets USP standards for size 2 suture, except for an oversize in diameter. The SutureTape modifications as compared to the predicate device(s) include smaller tape width (1.3mm vs. 1.5mm), lack of a suture core and different braiding pattern of colored yarns. Additionally, SutureTape is braided flat similar to the cleared LabralTape (K122374) but has round suture tails similar to the cleared FiberTape (K032245).
The provided text is a 510(k) summary for a medical device called "SutureTape." It describes the device, its intended use, and performance data from various tests. However, it does not contain information about a study involving AI or human readers, or any other details related to AI performance criteria.
Therefore, many of your requested points cannot be answered from the provided document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Strength (straight pull, knot pull, needle pull) exceeds USP requirements for size 2 suture | Exceeds USP requirements for size 2 suture (based on diameter of suture ends spanning USP size 1 and 2 diameter ranges) |
| Pyrogen limit specifications (Bacterial endotoxin testing per EP 2.6.14/USP ) | Meets pyrogen limit specifications |
| Biocompatibility | Acceptable (due to similarities with predicate) |
| Shelf-life | Acceptable (due to similarities with predicate) |
2. Sample size used for the test set and the data provenance: Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI-assisted diagnostic device. The "ground truth" here refers to established standards (USP requirements, EP/USP standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used: For mechanical properties, the ground truth is United States Pharmacopeia (USP) requirements for surgical sutures. For pyrogen testing, the ground truth is EP 2.6.14/USP standards. Biocompatibility and shelf-life are determined based on similarity to predicate devices.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
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(106 days)
The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used in conjunction with FiberTape, they can be used to treat patella fractures.
The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.
The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainless steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape.
The provided document is a 510(k) premarket notification for a medical device called "Arthrex Blunt Tip Screws with FiberTape." This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
Unfortunately, this document does not contain the detailed information required to fill out all parts of your request regarding acceptance criteria and a study proving device performance.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the device is "substantially equivalent" to predicate devices based on "Geometrical analysis" and "the summary of data submitted." It does not provide a table with specific performance acceptance criteria (e.g., tensile strength thresholds, bending stiffness limits) or detailed reported device performance values for these criteria.
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| No specific criteria or performance values provided in text. | No specific criteria or performance values provided in text. |
| (Hypothetical: Tensile Strength > 100N) | (Hypothetical: 120N) |
| (Hypothetical: Fatigue Life > 1,000,000 cycles) | (Hypothetical: 1,500,000 cycles) |
2. Sample size used for the test set and data provenance:
The document mentions "Geometrical analysis" and a "summary of data submitted" but does not specify numerical sample sizes for any test sets. It also does not discuss data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and qualifications:
Not applicable to this type of submission. This document pertains to mechanical properties and substantial equivalence, not clinical diagnostic performance or expert consensus on a test set.
4. Adjudication method for the test set:
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is a medical device for internal bone fixation and soft tissue approximation, not a diagnostic imaging device typically evaluated with MRMC studies.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used:
The "ground truth" in this context is the performance of the legally marketed predicate devices. The submission implies that the Arthrex Blunt Tip Screws with FiberTape either meet or exceed the performance of these predicates, or that any differences do not raise new questions of safety or effectiveness. The methods used to establish this "ground truth" for the predicate devices would have been their own clearance processes, likely involving mechanical testing and potentially clinical data.
8. Sample size for the training set:
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is present in the document relevant to your query:
- Device: Arthrex Blunt Tip Screws with FiberTape
- Purpose of Submission: To obtain clearance for the device for internal bone fixation for bone fractures in the patella.
- Method for demonstrating equivalence: "Geometrical analysis" and "summary of data submitted" demonstrate substantial equivalence to predicate devices.
- Predicate Devices:
Conclusion Regarding your Request:
The provided 510(k) clearance letter and summary confirm the FDA's determination of substantial equivalence for the Arthrex Blunt Tip Screws with FiberTape to predicate devices. However, it does not contain the detailed study results, specific acceptance criteria, sample sizes, or expert involvement data that you requested. These details would typically be found in the manufacturer's internal test reports or the full 510(k) submission, portions of which are not public in this summary document. The document emphasizes mechanical and design equivalence rather than diagnostic performance assessed by human readers or algorithms.
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