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The NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

NuGen™ FX Screw is composed of poly-L,D-lactide copolymer. It is supplied partly threaded with 3.5mm in diameter, lengths 14-40mm and 4.5mm in diameter, lengths 24 - 70mm.

The provided text describes a 510(k) submission for a medical device called the NuGen™ FX Screw. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, expert involvement, and ground truth establishment are not applicable or extractable from this type of FDA submission. The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to independently prove its effectiveness with new clinical trials.

Here's an assessment based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This document does not present specific quantitative acceptance criteria or a study designed to measure the NuGen™ FX Screw's performance against such criteria. The "performance" being demonstrated is its substantial equivalence to predicate devices, implying similar safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. There is no mention of a distinct "test set" in the context of device performance testing in this document. The substantial equivalence argument relies on comparing the new device's characteristics (design, materials, intended use, operating principle, packaging, sterilization, shelf life) to those of predicate devices, which would have undergone their own testing previously.

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. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set 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:

Not applicable. This is a medical implant device, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The document discusses substantial equivalence based on the device's characteristics and intended use being similar to existing predicate devices.

8. The sample size for the training set:

Not applicable. No "training set" in the context of algorithm development or performance testing is mentioned.

9. How the ground truth for the training set was established:

Not applicable. No "training set" or ground truth establishment for it is mentioned.

Summary of Device Acceptance and "Study" (Demonstration of Substantial Equivalence):

The "acceptance criteria" for the NuGen™ FX Screw, as presented in this 510(k) submission, are effectively the conditions for demonstrating substantial equivalence to predicate devices. The "study" that proves the device meets these criteria is the comparison and argument presented in the submission itself.

Acceptance Criteria for Substantial Equivalence (implied from the document):

• Same indicated use: The NuGen™ FX Screw must have the same intended use as the predicate device(s).
• Same operating principle: The fundamental way the device achieves its intended action must be the same.
• Same basic design of thread: The screw thread design should be consistent.
• Same basic dimensions: The general size ranges should be comparable.
• Packaged and sterilized using the same materials and processes: Consistency in these aspects ensures similar safety profiles.
• Same shelf life: The stability and integrity over time should be equivalent.
• No new issues of safety or effectiveness: Any differences from the predicate devices must not raise new questions about the device's safety or how well it works.
• Similar materials: The raw materials used should be the same as or previously accepted for similar devices.

Reported Device Performance (as demonstrated for substantial equivalence):

The document asserts that the NuGen™ FX Screw meets these implicit criteria by stating:

• "NuGen™ FX Screw has the following similarities to the cleared SmartScrew (K003077):
  • has the same indicated use
  • uses the same operating principle
  • incorporates the same basic design of thread
  • utilizes the same basic dimensions
  • is packaged and sterilized using the same materials and processes
  • has the same shelf life"
• "This raw material and design of head of screw are already introduced with fully threaded screw model (K012001)."
• "In summary, the NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the NuGen™ FX Screw and the predicate devices do not raise any new issues of safety or effectiveness."

The FDA's decision letter (K023022) confirms their agreement with this assessment: "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

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The BioSorbFX O/M 2.0/2.4 System is intended for use in trauma and reconstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes bone during healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:

1. Mandibular tumor resection.
2. Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
3. Significant comminuted fractures, including significant bone loss; of the mandible.
4. Intermaxillary fixation without an appropriate external fixation by other means.

The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks.

Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors.

Here's an analysis of the provided text regarding the BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific, novel acceptance criteria through extensive clinical trials for efficacy and safety. Therefore, much of the requested information (like detailed acceptance criteria and standalone study results, detailed ground truth establishment for a training set, or MRMC studies) is generally not found in a 510(k) summary for this type of device. The focus is on demonstrating that the new device is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a bone fixation system, the "acceptance criteria" are primarily related to material specifications, mechanical properties, and equivalence in intended use and operating principles to predicate devices. The document does not explicitly state quantitative "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance is implicitly "accepted" if found substantially equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of an AI/software algorithm evaluation. Instead, the submission relies on:

• Engineering/Bench Testing: Implied by the discussion of material properties (strength retention, biodegradation). No specific sample sizes for these tests are provided in this summary.
• Comparison to Predicate Devices: The primary "test" is to demonstrate substantial equivalence to previously cleared devices. This involves comparing specifications, intended use, operating principles, and materials. The "sample" in this case is the new device itself, being compared element-by-element to the predicate devices.
• Data Provenance: Not applicable in the context of human data. The "data" here refers to the device's design, material properties, and intended function.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a bioabsorbable fixation system, not a diagnostic AI system requiring expert-established ground truth from medical images or patient data. The "ground truth" for this submission is whether the device's characteristics (material, strength, design, intended use) are substantially equivalent to legally marketed predicate devices, which is assessed by the FDA based on the submission's technical details.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication method" in the sense of resolving discrepancies in expert interpretations, as there's no expert labeling task described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a surgical implant designed to stabilize bone, not a diagnostic tool, and therefore an MRMC study is not relevant or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the evaluation of the device's physical and mechanical properties (material composition, strength retention, biodegradation time) can be considered a "standalone" assessment of the device's intrinsic characteristics. However, this is not an "algorithm-only" standalone performance as typically discussed for AI/software. The device itself (the implant) is the "standalone" subject of the evaluation, separate from its use in a patient (human-in-the-loop). No specific study in this format is detailed beyond the general statements of properties.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices already on the market. The BioSorbFX™ O/M 2.0/2.4 System is deemed safe and effective because it is substantially equivalent to these predicate devices. The factual basis for this substantial equivalence includes:

• Material Science/Engineering Data: Data on the polymer composition, strength, and degradation characteristics.
• Design Specifications: Detailed blueprints and specifications of the plates, screws, and instrument set.
• Previous FDA Clearances: The regulatory history and clearance (510(k) numbers K982139, K982721, K981666, etc.) of the predicate devices serve as the "ground truth" for what is considered safe and effective for this product type.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved.

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1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000)
Lengths of implants are 14, 16, 18, 20 and 25 mm. -
Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) and -1.5mm Bone Fixation Kit (K012000)
Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000). -
Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The modifications are:

Amendment of new length, 14mm implant, into product line. -
Modified design accordingly. -

The provided 510(k) summary does not contain the detailed information typically associated with acceptance criteria and a study that proves a device meets those criteria, especially for a software-based medical device.

This submission is for a physical medical device: the 1.5mm Bone Fixation Kit, an absorbable bone fixation nail. For such devices, "acceptance criteria" and "study" would typically refer to mechanical and material testing, and possibly pre-clinical (animal) or limited clinical trials (human) demonstrating safety and performance. However, this submission focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed study results.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of acceptance criteria or reported device performance in the way a software or AI device submission would. Instead, it relies on demonstrating that the revised device (with a new length and minor design modification) is substantially equivalent to existing cleared devices.

The key performance aspect mentioned is:

• "This modification has no effect on pull-out properties of the device."
  • This is a critical mechanical property for bone fixation devices, implying that testing was conducted to ensure the pull-out strength of the modified device remained comparable to the predicate. However, no specific values, criteria, or test results are provided in this summary.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not mentioned. It's likely that mechanical and material testing involved a certain number of implants, but this detail is not in the summary.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable to a physical bone fixation device. "Ground truth" in this context would be established through engineering and material testing standards.

4. Adjudication method for the test set

• This is not applicable to
  a physical bone fixation device.

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 as the device is a physical bone fixation implant, not a diagnostic or AI-assisted device for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the device is a physical bone fixation implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For this device, "ground truth" would be established through recognized engineering standards for mechanical strength (e.g., pull-out strength, bending strength), material biocompatibility, and degradation rates. The submission states the device uses the "very same raw material" as predicates, implying material properties are consistent. Specific details of these tests and their results are not included in the summary.

8. The sample size for the training set

• This question is not applicable as the device is a physical bone fixation implant. There is no AI or machine learning component requiring a training set.

9. How the ground truth for the training set was established

• This question is not applicable as the device is a physical bone fixation implant.

Summary of Device Performance (Based only on the provided text):

The device performance is inferred from its substantial equivalence claim, specifically:

• The material (poly-L/D-lactide copolymer) is identical to predicate devices.
• The diameter (1.5mm) is identical to predicate devices.
• The shelf life is identical to predicate devices.
• Crucially, the submission explicitly states: "This modification has no effect on pull-out properties of the device." This implies that testing was conducted to confirm this, and the device performs equivalently to the predicates in terms of its ability to fix bone fragments without prematurely dislodging.

Missing Information:

The 510(k) summary provided here is a high-level overview focused on substantial equivalence. It lacks the specific details of mechanical testing methodologies, quantitative acceptance criteria (e.g., minimum pull-out strength in Newtons), and the actual test results that would typically be reviewed by the FDA as part of the full submission for a physical device. These details are generally found in the comprehensive testing reports within the complete 510(k) submission, not typically in the public-facing summary document.

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Properly used, in the presence of adequate immobilization, absorbable BioCuff CM screw/washer maintains proximity between soft tissue and bone to facilitate the soft tissue reattachment. BioCuff C™ loses its strength over 20 to 50 weeks while the lesion of the tendon is healing. This indication is completely identical with the previously cleared BioCuffM (K001378).

The BioCuff C™ is not intended for use in and is contraindicated for: 1) Insufficient quality or quantity of bone, 2) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity. 3) Patients with active sepsis or infection. 4) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.

BioCuff CTM is composed of poly-L/D-lactide copolymer. This raw material is completely identical with the previously cleared Bionx Implants Inc. BioCuff™ (K001378).

The device description of BioCuff C™ screw and washer combination is as follows:

• Composed of poly-L/D-lactide copolymer
• -Lengths 18, 28 and 36mm.
• Diameter 6.0 mm
• -Cannulation for 1.5mm K-wire

The only modifications that were made are:

• Cannulated design for easier installation of the product
• Increased outer diameter
• Minor design changes in head of the screw and washer accordingly
• Revision of instrument set according to needs of cannulation. This means cannulated screwdriver, cannulated drill, grasper, cannulated bone tap, sterilization tray and K-wire. Instrument set is substantially equivalent to previously cleared Bionx Implants Inc. BioCuff™ screw/washer (K001378) and Cannulated SmartScrew (K974876, K992947).
• Introduction of new reference numbers
• Introduction of new trade name, BioCuff CTM

This 510(k) submission (K013057) for the Bionx Implants Inc. BioCuff CTM is for a bioabsorbable soft tissue fixation fastener. The submission establishes substantial equivalence to a predicate device, the Bionx Implants Inc. BioCuff™ (K001378).

The core of this submission is demonstrating that the BioCuff CTM is substantially equivalent to the predicate device, BioCuff™. This means the acceptance criteria are implicitly those of the predicate device, and the study proves the new device meets these criteria by showing it has the same or very similar performance and safety characteristics.

Here’s an breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on minor modifications and identical materials to a predicate, explicit numerical acceptance criteria and a detailed performance study with reported values for the new device (BioCuff CTM) against those criteria are not provided in the document in the format you expect for a novel device. Instead, the "acceptance criteria" are implied to be the performance characteristics of the predicate device, which the new device is claimed to match.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe an independent clinical or performance study with a test set of patients or devices where data was collected. This 510(k) relies on a declaration of substantial equivalence to a previously cleared device. Therefore, there is no mention of a "test set" and thus no sample size or data provenance in the context of a new performance study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

No new test set was used, and thus no expert ground truth establishment for a new test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable as no new test set and no expert review for a new test set were conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or mentioned. The device is a physical implant, not an AI or imaging diagnostic tool that would typically involve a MRMC study.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a medical device (implant), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this submission is effectively the established safety and effectiveness profile of the predicate device (BioCuff™ K001378). The new device's substantial equivalence is argued based on its identical material, intended use, and minor design changes that do not alter its fundamental function or safety profile.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "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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The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The device description of the Contour Meniscus Arrow™ is as follows.

• Composed of poly-L/D-polylactide copolymer
• Length 10, 13 and 16mm
• Diameter 1.1mm

The provided text is a 510(k) summary for the Contour Meniscus Arrow™, which focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the manner requested (e.g., clinical performance, efficacy testing with specific metrics like sensitivity, specificity, or accuracy).

Instead, the document asserts substantial equivalence based on:

• Identical intended use.
• Same operating principle.
• Same basic design (with minor modifications to raw material and design).
• Same manufacturing, packaging, and sterilization processes.
• Same shelf life.

The 510(k) summary is a regulatory document to clear a medical device for marketing, not a scientific publication detailing a study that meets specific acceptance criteria in terms of analytical or clinical performance metrics. The FDA's letter (K012334/S001) confirms the substantial equivalence determination.

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not present in this type of regulatory submission. The device's "performance" in this context refers to its physical and functional characteristics being substantially equivalent to predicates, implying similar safety and efficacy without needing new clinical studies if the differences are minor and do not raise new questions of safety or effectiveness.

Based on the provided text, the answer is that the document does not contain the information requested about acceptance criteria and a study proving the device meets those criteria in terms of clinical or analytical performance metrics.

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The Contour Labral Nail™ 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 Contour Labral Nail™ 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 reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

The Contour Labral Nail™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ is composed of poly-L,Dlactide copolymer, its length is 20mm and diameter 3.5mm.

The provided text is a 510(k) Summary for the Bionx Implants Inc. Contour Labral Nail™. This document describes a medical device and its intended use, demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not present a study with acceptance criteria and device performance results in the way requested in the prompt (e.g., in the context of AI/software performance).

The request asks for information typically found in a clinical or performance study report for a diagnostic device or AI algorithm, particularly points related to ground truth, expert review, sample sizes for training/test sets, and comparative effectiveness studies.

Since the provided document is a 510(k) summary for a physical medical implant (a biodegradable soft tissue fixation fastener), these specific types of studies and acceptance criteria are not applicable or present in the text. The basis for clearance is demonstrating "substantial equivalence" to existing cleared devices, rather than a performance study meeting specific statistical criteria for accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill the request as stated with the provided input.

However, based on the principle of substantial equivalence, the "acceptance criteria" can be inferred as demonstration of similar characteristics and performance to the predicate device.

Here's how the information in the document relates to the prompt, albeit with caveats due to the nature of the device:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Inferred from Substantial Equivalence): The device must have "the same intended use, similar principles of operation and technological characteristics" as the predicate devices, and "the minor technological differences... do not raise any new issues of safety or effectiveness."
• Reported Device Performance: The document does not provide quantitative performance metrics (e.g., success rates, complication rates) for the Contour Labral Nail™. Substantial equivalence is the basis for its clearance, implying its performance is expected to be similar to the predicate devices which are already on the market.

2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study testing an algorithm on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI/diagnostic algorithm for this physical implant.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical implant, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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