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Ask a specific question about this device

Ask a specific question about this device

IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

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

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

2. Sample sizes used for the test set and the data provenance:

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

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:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

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

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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MIS dental implant system is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.30mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The subject devices, MIS Implants, are supplied sterile and packaged together with a cover screw which can be connected to the implant during the initial healing period after implant placement.

The implants and cover screws are made of titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The design and material of the implants and cover screws remain unchanged since most recently cleared 510(k).

The implants are also used with a wide range of previously cleared abutments which are sold separately.

This document is a 510(k) clearance letter for dental implants, not an AI/software as a medical device (SaMD) submission. Therefore, it does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/SaMD product.

The document discusses dental implants and their physical and material characteristics, regulatory classifications, predicate devices, and performance testing for mechanical properties, sterility, and packaging. The "Performance Data" section specifically mentions "Hydrophilicity testing" for "wet-packed implants" and other physical tests, but none of these relate to AI/SaMD performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide a table of acceptance criteria, sample sizes for test sets, expert qualifications, or details on MRMC studies, standalone performance, or ground truth establishment relevant to an AI/SaMD product based on the provided text.

The prompt asks for information that this type of medical device submission (dental implants) would not typically include.

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RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch.

There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

This document is an FDA 510(k) clearance letter for an RF Electrosurgical Device (RFMagik). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain information about acceptance criteria, device performance results, sample sizes, expert ground truth establishment, or clinical study details. The section on "Clinical Testing" explicitly states: "Clinical testing is not a requirement and has not been performed."

The document focuses on:

• Regulatory details: Device classification, product codes, indications for use.
• Technological comparison: Detailed comparison of the subject device (RFMagik) with a primary predicate device (RFMagik Lite) and a reference device (AGNES). This comparison highlights similarities and differences in handpieces, electrodes, output power, etc., and explains why these differences do not affect substantial equivalence.
• Non-clinical testing: Biocompatibility, sterility, shelf-life, and performance bench testing. An "Ex Vivo Study" was conducted on tissue types (liver, skin, muscle) for thermal testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for the test set, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. This information is typically found in specific study reports or sections of a 510(k) submission that go beyond what is published in the clearance letter itself.

The document indicates that the substantial equivalence was primarily demonstrated through bench testing and comparison to predicate devices, rather than clinical trials or extensive human-in-the-loop performance studies.

Summary of what CANNOT be provided from the given document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size for the test set and data provenance: No clinical test set. Ex vivo study mentioned, but specific sample sizes are not detailed.
3. Number of experts and qualifications for ground truth: Not applicable as no clinical study with expert ground truth review was performed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical electrosurgical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for a clinical study. Ex vivo study used physical tissue, but no "ground truth" akin to medical image labeling.
8. Sample size for the training set: Not applicable as there is no mention of an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in one or two adjacent spinal levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The previously cleared SABER-C interbody devices are offered manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers, as specified in ASTM F2026, ASTM F136, ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spikes or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
The subject submission seeks to expand size offerings and gain clearance for expanded indications and minor design modifications to the previously cleared devices.

The provided text is a 510(k) clearance letter for the SABER-C System, an intervertebral body fusion device. It details the regulatory clearance, indications for use, device description, and a brief summary of performance testing.

However, the document does not contain information related to a study proving the device meets acceptance criteria specific to an AI/ML algorithm, nor does it specify any AI/ML components within the SABER-C System. The performance testing listed is entirely mechanical/physical bench testing for a physical implant (Axial Screw Pullout, Insertion Torque, plate pushoff), which is standard for orthopedic devices.

Therefore, it is not possible to complete the requested table and answer questions about AI/ML acceptance criteria, study design, sample sizes for AI, expert involvement for AI ground truth, MRMC studies, or standalone algorithm performance based on the provided text. The document is for a traditional medical device, not a software as a medical device (SaMD) or an AI-enabled device.

To address the prompt directly based on the provided text, the answer is that the document does not contain the information requested, as the device is a physical implant and not an AI/ML enabled medical device.

Summary of missing information directly related to AI/ML acceptance criteria and study:

• No AI/ML Component: The document describes a physical interbody fusion device and its associated plates and screws. There is no mention of any AI or machine learning functionality.
• Acceptance Criteria for AI/ML: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Study Proving AI Compliance: There is no study described that would evaluate AI performance. The performance testing mentioned is purely mechanical (bench testing).
• Sample Size (AI): Not applicable, as there's no AI component.
• Data Provenance (AI): Not applicable.
• Experts for Ground Truth (AI): Not applicable.
• Adjudication Method (AI): Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance (AI): Not applicable.
• Type of Ground Truth (AI): Not applicable.
• Training Set Sample Size (AI): Not applicable.
• Training Set Ground Truth (AI): Not applicable.

If the prompt assumed an AI/ML component was present and requested how one would describe these aspects for a hypothetical AI/ML device in a similar FDA clearance, I would construct a general example. However, as the instruction is to describe "the study that proves the device meets the acceptance criteria" based on the input, and the input clearly does not describe an AI/ML device, the direct answer is that the information is not present.

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This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The device is suitable for professional healthcare facility environments such as hospitals and clinics.

This product shall not be used for other purposes.

The Single-Use Video Flexible Cysto-Nephroscope mainly consist of insertion portion, handle and connector section which include a detachable video cable which connect the endoscope to the Endoscopic Video Image Processor.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (Single-Use Video Flexible Cysto-Nephroscope), not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of the new device to a predicate device based on non-clinical performance testing of the physical properties and functionality of the endoscope itself. There is no mention of any AI component or software that processes images or provides diagnostic assistance.

Here's a breakdown of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The proposed device has met the testing acceptance criteria in accordance with internal requirements and applicable standards to support substantial equivalence of the proposed device." However, it does not provide a specific table listing detailed acceptance criteria and the corresponding reported performance values for each physical test. It only lists the types of tests performed.

• Sterilization Validation:
  • Acceptance Criteria: Determined by ISO 11135:2014 half-cycle method to establish routine control and monitoring parameters.
  • Reported Performance: Method validated. (Specific parameters not provided).
• Shelf Life and Simulated Transportation Distribution followed by Sterile Packaging Integrity Test:
  • Acceptance Criteria: Validated according to ASTM F1980-21, ISO11607-1:2019, ISO11607-2:2019, ASTM F1929-23, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23.
  • Reported Performance: Validated. (Specific results not provided).
• Performance Testing (using methods and acceptance criteria from K241500):
  • Surface and Edges:
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.
  • Deflection system and Fatigue test of Rocker and Bending Section: (Note: Downward deflection angle changed from 135° to 225° for all models).
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.

Information Not Applicable to this Device/Document (for AI/ML products):

The following points are typically relevant for AI/ML device submissions but are not found in this document because it pertains to a physical, non-AI medical instrument.

• Sample sized used for the test set and the data provenance: Not applicable. Evaluation was based on physical device testing, not a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The study described is a non-clinical performance testing study for a physical medical device (endoscope), designed to demonstrate substantial equivalence to a previously cleared predicate device. It involves component and system-level testing of physical characteristics, sterilization, packaging integrity, and functionality based on established industry standards and previous submission's methodologies. There is no AI or software performance evaluation in this clearance.

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For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood coagulation. Fibrinogen is also a useful marker in the evaluation of several disease states including disseminated intravascular coagulation, liver disease, inflammatory diseases and malignancy. High levels of fibrinogen are associated with an increased risk for cardiovascular disease. Increased levels are also found during pregnancy and oral contraceptive use, while reduced levels are found during thrombolytic therapy.

The HemosIL Fibrinogen-C kit and HemosIL Fibrinogen-C XL kit use an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of fibrinogen concentration.

This document, an FDA 510(k) clearance letter for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL, does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary clearly states:

• Reason for Submission: "This Special 510(k) is being submitted to remove the reconstituted reagent frozen stability claim of 1 month at -20°C in the original vial for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL."
• Data Requirement: "No new performance data are needed to remove the reconstituted reagent frozen stability claim."
• No new performance claims: "Changes to labeled performance claims, except to remove the reconstituted reagent frozen stability claim from the Instructions for Use and add 'Do not freeze reconstituted reagent.'"

Therefore, the document explicitly states that no new performance data or studies were required or submitted for this particular 510(k) clearance. The clearance is based on a minor labeling change related to reagent stability, not on new performance validation.

To provide the information you requested (acceptance criteria, study details, sample sizes, expert involvement, ground truth, etc.), you would need a different type of submission document, such as an original 510(k) application or a PMA, where initial and comprehensive performance validation studies are typically included.

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The Unimed disposable blood pressure cuff (Models U1682S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (4–15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.

The Unimed Disposable Neonatal NIBP Cuffs (Models U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N) are single-patient-use accessories for non-invasive blood pressure (NIBP) measurement. Each cuff is designed for neonatal limb circumferences ranging from 4 cm to 15 cm (Neonate 2 through Neonate 5) as follows.

• U1682S-C51N: 4 cm - 8 cm.
• U1683S-C51N: 6 cm - 11 cm.
• U1684S-C51N: 7 cm - 13 cm.
• U1685S-C51N: 8 cm - 15 cm.
  The cuffs are intended to be used with compatible blood pressure monitors employing oscillometry. They are non-sterile, and are disposed of after single-patient use to reduce cross-contamination risks.

This 510(k) clearance letter is for a Disposable Neonatal NIBP Cuff. It does not describe an AI/ML powered medical device, nor does it detail a study involving AI/ML.

Therefore, many of the requested criteria related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, etc.) are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing and material biocompatibility.

Here's the information that can be extracted from the provided text, primarily related to the non-clinical testing performed to meet acceptance criteria for a physical medical device:

Acceptance Criteria and Device Performance for Disposable Neonatal NIBP Cuff

The acceptance criteria for this device are primarily based on established international standards for non-invasive blood pressure cuffs and biocompatibility. The performance is demonstrated through non-clinical testing, confirming adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The non-clinical testing likely involved a representative sample of each cuff model (U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N).
• Data Provenance: The document states "Non-clinical tests were conducted..." but does not specify the country of origin where the testing was performed. Given the manufacturer's location (Shenzhen, China), it's plausible the testing was conducted there or at a certified lab supporting the manufacturer. The testing is described as non-clinical, implying it was laboratory-based product verification and validation, not retrospective or prospective human clinical data collection.

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

This is not applicable. This document describes the clearance of a physical medical device (NIBP cuff) via substantial equivalence, not an AI/ML algorithm. Therefore, there is no mention of "ground truth" derived from expert consensus on medical images or data. The "ground truth" for this device would be the defined specifications and performance requirements established by the relevant ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings, especially for AI/ML performance evaluation where multiple human readers might disagree on findings. For non-clinical device testing like this, adherence to predefined test protocols and specifications is the primary method of evaluation.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a non-AI medical device like a blood pressure cuff.

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

No, a standalone performance evaluation of an algorithm was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized consensus standards (ISO 81060-1, ISO 80601-2-30, and ISO 10993 series for biocompatibility). The device's performance metrics are evaluated against the specific requirements and test methods outlined in these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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