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The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.

Wave Electrode is an active analogue electrode for detecting any surface electromyographic signals, used for controlling prosthetic devices. It is compact and low-power, ensuring an accurate and fast reading of muscle electrical potentials generated voluntarily by the user. It also provides a real-time output signal proportional to the detected muscle activation. Through the Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral amputees, starting from a transradial amputation level) and send an electrical signal to the electronic board of the prosthetic hand with a proportional width to the detected contraction. Wave Electrode is only compatible with the Adam's Hand that, according to the Requlation Number 890.3420, are classified as class I medical device. Wave Electrode is available in two different models: Mod. AE02-50, with notch filter centred on the 50 Hz frequency; Mod. AE02-60, with notch filter centred on the 60 Hz frequency

This document is a 510(k) Premarket Notification from BionIT Labs Srl for their Wave Electrode (AE02-60; AE02-50) devices, seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain acceptance criteria or performance studies in the way you might expect for a novel device or AI/ML algorithm.

Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and functional compatibility with a specific prosthetic hand. The performance is assessed by meeting these standards and ensuring the device operates as intended alongside the "Adam's Hand®" prosthetic hand.

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

This information is not provided in the document. The non-clinical performance data refers to "internal testing" and testing by "an accredited laboratory," but specifics on sample sizes, types of data (e.g., specific scenarios, duration), provenance, or study design are omitted.

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)

This information is not applicable/not provided as there is no mention of a ground truth established by experts in the context of diagnostic or interpretive performance for an AI/ML algorithm. The device is a cutaneous electrode for EMG signal detection, and its performance is evaluated against engineering and biological safety standards, not against an expert-derived ground truth for an interpretation task.

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

This information is not applicable/not provided. As explained above, there's no mention of a ground truth derived from expert adjudication for interpretive tasks.

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 MRMC comparative effectiveness study was done or mentioned. This type of study is typically relevant for AI/ML-driven diagnostic or interpretive devices that assist human readers. The Wave Electrode is a hardware device for signal acquisition, not an AI/ML diagnostic tool.

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

No standalone algorithm-only performance study was done or mentioned. The device itself is hardware. The document states it is an "analog device and has no on-board programmable electronics (FW and or PEMS)."

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

Given the nature of the device (cutaneous electrode), the "ground truth" implicitly refers to:

• Engineering specifications and recognized standards: Performance is measured against criteria for electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993 series).
• Intended function: The ability to "detect, process, and transmit physiological signals" and operate as intended "in conjunction with 'Adam's Hand®' prosthetic hand."

There is no mention of ground truth related to medical diagnoses, pathology, or outcomes data, as these are not relevant to the function of a cutaneous EMG electrode.

8. The sample size for the training set

This information is not applicable/not provided. The Wave Electrode is described as an analog device without programmable electronics or software. Therefore, there is no AI/ML algorithm that would require a "training set."

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

This information is not applicable/not provided for the same reasons as point 8.

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This is an EEG electrode set intended for routine clinical settings where rapid placement of a large number of EEG electrodes is desired. Patient population from infants up to any age.

WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in Chin-strap (placed under the chin). Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 different cap sizes.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "WaveGuard Net EEG Cap." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven system.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" requested in the prompt are typically associated with performance validation studies for software or AI/ML-based medical devices, often requiring clinical or technical performance metrics against a defined ground truth.

This 510(k) summary primarily addresses:

• Device Description: What the device is (EEG electrode cap with saline-soaked electrodes).
• Intended Use: For routine clinical EEG settings.
• Comparison to Predicate Device: How it's similar and different from a previously cleared device (WaveGuard EEG Cap K110223). Key differences noted are electrode material (Coated Ag vs. Sintered Ag/AgCl), cap material (Silicone Mesh vs. Lycra), and Magnetic Resonance compatibility (MR unsafe vs. MR safe).
• Non-Clinical Testing: This section refers to performance standards and biocompatibility testing for the device itself (like electrical safety, material safety), not against an AI/algorithm's predictive accuracy or diagnostic performance. The listed standards (e.g., ISO 10993 series, 21 CFR PART 898) relate to safety, material characteristics, and electrical performance of electrodes/cables.

Therefore, based on the provided text, it is not possible to extract the information requested in the prompt, as the document does not describe a performance study for an AI/algorithm-driven device with accuracy, sensitivity, or specificity metrics.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance for an AI/algorithm. The document discusses performance standards for an electrode cap (e.g., electrical safety, biocompatibility), not a software's classification or prediction accuracy.
2. Sample size used for a test set or data provenance for an AI/algorithm validation.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm test set.
4. Adjudication method for an AI/algorithm test set.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a physical electrode cap, not an AI or software assistant for human readers.
6. Information on standalone (algorithm-only) performance. Again, this is a physical device.
7. The type of ground truth used in the context of an algorithm's performance. The "ground truth" for this device would relate to its physical and electrical properties meeting specified standards.
8. Training set sample size for an AI/algorithm.
9. How ground truth for the training set was established for an AI/algorithm.

The document's "Performance Data / Summary of Non-Clinical Testing" section refers to:

• 21 CFR PART 898—Performance Standard for Electrode Lead wires and Patient Cables: This regulation sets electrical safety and performance standards for the physical components of the EEG cap.
• Biocompatibility testing (ISO 10993 series): This ensures the materials in contact with the patient are safe (non-toxic, non-irritating, etc.).

These are standard regulatory requirements for all medical devices like EEG caps, not specific to the validation of AI/ML software.

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The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

The provided text describes a 510(k) premarket notification for the WaveSense Jazz Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to a predicate device (K072413), rather than presenting a de novo clinical study with detailed acceptance criteria and performance data as typically seen for novel devices, especially those incorporating AI.

Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving device performance (especially for an AI/ML context) is largely absent from this specific 510(k) summary. The document primarily discusses the intended use, technological comparison to a predicate, and the modifications made (new colors, new data management feature), implying that much of the performance data would have been established for the original predicate device.

However, I can extract the relevant information that is present and indicate where information is not available from the provided text.

Here's an attempt to answer based on the provided document, acknowledging its limitations for an AI/ML-centric request:

Acceptance Criteria and Device Performance (based on the provided 510(k) Summary for a Glucose Monitoring System)

It's crucial to understand that this 510(k) pertains to a Blood Glucose Monitoring System, which is a hardware-based diagnostic device, not an AI/ML-powered software or imaging device. Therefore, many of the typical questions regarding AI/ML clinical studies (MRMC, expert consensus for ground truth, training set details, etc.) are not applicable to this type of submission.

The "study" referenced in the provided text is primarily focused on verification and validation (V&V) of the modifications made to an existing predicate device, rather than a large-scale clinical trial to establish novel performance.

1. Table of Acceptance Criteria and Reported Device Performance

For a Blood Glucose Monitoring System, acceptance criteria usually relate to accuracy standards (e.g., ISO 15197 for point-of-care testing), precision, and other analytical performance characteristics. The provided 510(k) summary does not explicitly list these numerical acceptance criteria or the specific performance results in a table. It instead states that "verification and validation results" were sufficient to establish substantial equivalence.

However, based on typical FDA requirements for Blood Glucose Monitoring Systems, the implicit acceptance criteria would relate to:

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Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

No-profile Implants w/ Screws:

The SeaSpine WaveForm A System No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.

No-profile Implants w/ Inline Fixation Anchors:

The SeaSpine WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine WaveForm A Noprofile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine WaveForm A System Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.

The WaveForm A Interbody System consists of anterior intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic configurations to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.

The WaveForm A Interbody can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile Interbody configurations. Fixation implants include Anterior Plates, Spin Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.

The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

This document describes the FDA's 510(k) clearance for the SeaSpine WaveForm A Interbody System. In this case, the clearance is based on substantial equivalence to predicate devices, meaning extensive clinical studies or specific acceptance criteria for device performance as a standalone AI system are not provided in this document.

Here's a breakdown of the requested information based on the provided text:

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

Based on the provided text, the device is cleared based on demonstrating substantial equivalence to legally marketed predicate devices, not on meeting specific quantitative performance metrics against a defined acceptance criterion for a novel AI function. The "acceptance criteria" here are implicitly that the device performs as well as or similarly to the predicate devices.

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

Not applicable. This is not an AI/software device that undergoes testing with a "test set" of patient data. The evaluation is for a physical intervertebral body fusion device and is based on non-clinical (mechanical) testing and comparison to predicate devices, not a clinical data set.

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

Not applicable. See point 2.

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

Not applicable. See point 2.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an implantable medical device, not an AI software intended to assist human readers.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. The "ground truth" for this device's clearance is that its design, materials, and mechanical performance are substantially equivalent to legally marketed predicate devices, as demonstrated through non-clinical mechanical testing.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

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The WavelinQ™ Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The WavelinQ™ Generator is a high frequency isolated generator that utilizes electrical current to deliver radiofrequency (RF) energy to the catheter electrode for formation of a vascular fistula. The generator offers a receptacle for a monopolar handpiece. The WavelinQ™ Generator is intended to be used with the currently marketed and cleared device WavelinQ™ EndoAVF System (K192239). The generator has one setting (AV1) equivalent to the mode (Cut T, 60W, 0.7s) of the predicate device, ESU-1 Electrosurgical Generator, that is used during the WavelinQ™ EndoAVF System procedure. This mode is set to deliver energy at 60 Watts for 0.7 seconds. The generator has a return electrode contact, for use with a split ground pad, and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use only a split return electrode, also referred to as a split ground pad.

The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).

The provided text is a 510(k) Summary for a medical device (WavelinQ™ Generator) and does not contain information about an AI/ML-based device. Therefore, it is not possible to describe acceptance criteria, a study proving device performance, or details regarding AI/ML ground truth, expert opinions, or MRMC studies, as none of that information is applicable to this document.

The document discusses the substantial equivalence of the WavelinQ™ Generator to a predicate device based on its intended use, indications for use, technological characteristics, and performance testing for electrical safety, mechanical aspects, reliability, and functionality. The tests performed are standard for electro-surgical devices and do not involve AI/ML components or human interpretation of outputs that would require multi-reader studies or complex ground truth establishment for AI model evaluation.

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The SeaSpine WaveForm L™ System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L 1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical, cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine WaveForm L™ System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc hermiation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The SeaSpine WaveForm L System is intended for use with supplemental fixation.

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation.

The Seaspine WaveForm Lumbar Systems are additively manufactured intervertebral fusion devices that feature a sodium hydroide (NaOH) surface treatment which results in a microroughened surface over the entirety of the implant. The devices include both NaOH treated and non-treated versions and have large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. WaveForm Lumbar System includes 3 different implants:

• A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred to as WaveForm L
• . A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm TO, and
• . A curved, banana-shaped cage, intended for transforaminal surgical placements, and referred to as WaveForm TA

The implants are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.

The provided document is a 510(k) summary for the SeaSpine WaveForm Lumbar Systems. It describes the device, its intended use, and a summary of non-clinical testing. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of diagnostic performance or AI effectiveness.

Specifically, the document focuses on the mechanical performance and substantial equivalence of the intervertebral body fusion device to predicate devices, as required for FDA 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria for diagnostic performance or AI, as this type of information is not present in the given text.

The closest relevant information, which pertains to device performance in a mechanical sense (not diagnostic or AI performance), is:

Non-Clinical Testing:
"The SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion."

The document concludes that the device performs at least as safely and effectively as the predicate based on these non-clinical mechanical tests, implying these standards serve as the "acceptance criteria" for mechanical performance and safety for this type of medical device.

To directly answer your numbered points based only on the provided text, many will be marked as "Not Applicable" or "Not Provided" due to the nature of this regulatory document:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit for non-clinical mechanical performance): Adherence to standards ASTM F2077, ASTM F2267, ASTM F1877, and successful Expulsion testing, demonstrating equivalent mechanical performance to the predicate device (K082310: SeaSpine Spacer System - Pacifica).
   • Reported Device Performance: "The SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion."

2. Sample size used for the test set and the data provenance: Not applicable. This document describes mechanical testing, not a diagnostic test with a "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process for a "test set" (related to diagnostic or AI performance) is mentioned.

4. Adjudication method 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 document does not concern AI or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not concern an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic or AI performance. For the mechanical tests, the "ground truth" would be the established testing parameters and results of the predicate device.

8. The sample size for the training set: Not applicable. This document does not describe AI development or training.

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

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The SeaSpine WaveForm™ L System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical, cancellous and/or corticocancellous bone, Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine WaveForm™ L System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm™ L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

The SeaSpine WaveForm™ L System is intended for use with supplemental fixation.

When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation.

The Seaspine WaveForm™ Lumbar Systems are additively manufactured intervertebral fusion devices with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. WaveForm™Lumbar System includes 3 different implants:

• A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred to as WaveForm™ L
• A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm™ TO, and
• A curved, banana-shaped cage, intended for transforaminal surgical placements, and referred to as WaveForm™ TA, and

The implants are manufactured from Ti-6AI-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) Pre-Market Notification from the FDA regarding the SeaSpine WaveForm™ Interbody Systems. It pertains to spinal implants, not an AI/ML medical device. Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not applicable to this document.

The document primarily focuses on:

• Submission Information: Date of submission, contact details, device names (WaveForm™ L, TO, TA Interbody Systems).
• Regulatory Classification: Class II medical device, product codes MAX, PHM, regulation number 21 CFR 888.3080 (Intervertebral Body Fusion Device).
• Predicate Devices: Lists previously cleared devices (K082310, K163230, K181079, K192132) that the new device is compared against for substantial equivalence.
• Device Description: Additively manufactured intervertebral fusion devices made from Ti-6AI-4V ELI titanium alloy, designed with central graft windows for autogenous and/or allogeneic bone graft. Specifies three types (L, TO, TA) for different surgical placements.
• Indications for Use: Details the specific conditions and anatomical locations for which the devices are intended, primarily degenerative disc disease (DDD) and spondylolisthesis in the lumbar and thoracolumbar spine. Emphasizes use as an adjunct to fusion with supplemental fixation and after non-operative treatment.
• Technological Characteristics: States that the devices are identical or similar to predicate devices in components, design, materials, and mechanical performance.
• Non-Clinical Testing: Mentions that mechanical performance equivalence was demonstrated (to the predicate systems) according to ASTM standards F2077, F2267, and F1877.
• Conclusion: The submitted data supports that the SeaSpine WaveForm™ Lumbar Systems perform at least as safely and effectively as the cited legally marketed predicate devices.

Since the request explicitly asks for details related to an AI/ML medical device and a study proving the device meets acceptance criteria, which is not present in this document, I cannot provide the requested information. This document is a clearance for a traditional medical implant, not an AI/ML system.

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The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

The WavelinQ™ EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation.

The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment.

The provided text describes the WavelinQ EndoAVF System and its substantial equivalence to a predicate device (WavelinQ 4F EndoAVF System). However, it does not contain detailed information about specific acceptance criteria for a diagnostic performance study, nor does it describe a study that uses a test set, ground truth, or expert readers/adjudication in the way requested in the prompt.

The document refers to "acceptance criteria" in the context of device design verification and validation, but these appear to be related to engineering, safety, and functionality, rather than a diagnostic performance study comparing device outputs to a ground truth established by experts.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not present in the provided text.

The closest information related to testing is in the "Performance Data: Non Clinical Performance Data" section, which lists:

• Electrical Safety per IEC 60601
• Electromagnetic Compatibility (EMC) Testing
• Design Validation Cadaver Study
• Magnet Array Force Coaptation Testing
• S-Turn Tortuosity Coaptation and Alignment Comparison Testing

These tests are primarily focused on the physical and functional performance of the device's components and its ability to create the fistula, rather than assessing a diagnostic output against a clinical ground truth.

The document states: "The subject device, WavelinQ™ EndoAVF System, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This is a general statement of compliance but does not provide the specifics requested for a diagnostic performance study.

In summary, the provided text does not contain the information necessary to fulfill the request for acceptance criteria and study details related to diagnostic performance.

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The WaveLight FS200 Patient Interface 1515 is indicated to be used only with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

The WaveLight® FS200 Patient Interface 1515 is a patient consumable (disposable) consisting of a tubing system with an integrated suction ring and an applanation cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.

This document is a 510(k) Premarket Notification for the WaveLight FS200 Patient Interface 1515. It is a Class II medical device (product codes GEX/HNO) intended for use with the WaveLight FS200 Laser System in ophthalmic surgical procedures.

The device is a sterile, disposable consumable consisting of a tubing system with an integrated suction ring and an applanation cone. The application being considered here is for a Patient Interface device, which connects a patient's eye to a laser system. This is a physical component, not a software or AI-driven diagnostic device. Therefore, the typical "acceptance criteria" and "study" questions related to AI/software performance (e.g., sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment by experts) are not applicable in this context.

Instead, the acceptance criteria and supporting studies for this type of device focus on manufacturing, material, sterility, packaging, and functional performance, demonstrating equivalence to an existing (predicate) device.

Here's the information extracted and formatted as requested, with "N/A" for sections not relevant to this device type:

Acceptance Criteria and Study for WaveLight FS200 Patient Interface 1515

The acceptance criteria for this device are demonstrated through non-clinical testing to ensure its safety, performance, and substantial equivalence to a predicate device, the WaveLight FS200 Patient Interface 1505. The studies performed are primarily engineering and laboratory-based tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices/units, but functional testing was performed on units after sterilization, transportation, and aging (accelerated and real-time). The specific number of units tested for each non-clinical test (biocompatibility, sterility, packaging, transport stability, functional testing) is not provided in this summary. These are typically engineering validation tests with defined sample sizes based on statistical methods/standards rather than patient data cohorts.
• Data Provenance: The studies are non-clinical, meaning they are laboratory and engineering tests conducted by the manufacturer (Alcon Research, Ltd.). The data originates from these controlled testing environments. Given this is a 510(k) submission to the US FDA, the tests would be expected to meet international and US-specific standards. This is retrospective in the sense that the studies detailed were completed prior to submitting the 510(k) application.

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

• N/A. This device is a physical consumable, not an AI/diagnostic imaging device that requires expert review for "ground truth" establishment in a clinical performance study context. Ground truth is established through validated testing methodologies and adherence to recognized consensus standards (e.g., ISO for sterility, biocompatibility, packaging; ASTM for aging).

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (e.g., 2+1, 3+1) refer to procedures for resolving discrepancies in expert clinical assessments (e.g., image interpretations). This is not relevant to non-clinical engineering and laboratory validation tests.

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 medical device, not an AI or software product. MRMC studies are not applicable.

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

• N/A. This is a physical medical device, not an algorithm. Standalone performance as typically described for AI/software is not applicable.

7. The Type of Ground Truth Used

• Engineering and Laboratory Standards / Test Results: The "ground truth" for this device's performance is established by demonstrating adherence to recognized consensus standards (e.g., ISO 10993, ISO 11135, ISO 11607, ASTM F1980) and by comparative functional testing against the predicate device. For example, sterility "ground truth" is meeting a 10⁻⁶ SAL, biocompatibility "ground truth" is passing specific ISO 10993 tests, and functional "ground truth" is equivalence to the predicate device's measured performance.

8. The Sample Size for the Training Set

• N/A. This device does not involve a "training set" in the context of machine learning or AI models.

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

• N/A. As above, no training set for AI/ML is involved.

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The WavelinQ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

The WavelinQ™ 4F EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation.

The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment.

The provided text describes the performance data for the WavelinQ™ 4F EndoAVF System, a medical device for creating arteriovenous fistulas (AVFs) for hemodialysis access. It is not an AI/ML device, so the typical AI/ML acceptance criteria and study information (like sample size for training data, number of experts for ground truth, MRMC study, or standalone performance of an algorithm) are not applicable or detailed in the document.

The document primarily focuses on demonstrating the device's substantial equivalence to a predicate device through clinical performance data, rather than showing how an algorithm meets specific acceptance criteria based on AI/ML metrics.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance specific to AI/ML metrics. The document lists clinical endpoints and their outcomes.
• Sample size used for the test set and data provenance in the context of AI/ML validation. The study uses a pooled clinical cohort.
• Number of experts used to establish ground truth or their qualifications for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone performance of an algorithm.
• Sample size for the training set for an AI/ML algorithm.
• How ground truth for the training set was established for an AI/ML algorithm.

However, I can provide the available information regarding the clinical study and its outcomes as presented in the document:

Clinical Study for WavelinQ™ 4F EndoAVF System

The study was conducted to confirm that the WavelinQ™ 4F EndoAVF System is a substantially equivalent treatment option for patients in need of hemodialysis access.

1. Table of Acceptance Criteria (Clinical Endpoints) and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets in the same way an AI/ML study would define performance thresholds. Instead, it describes "Primary effectiveness endpoints" and "Primary safety endpoints" and reports the observed rates. While not explicitly stated as "acceptance criteria," these are the performance outcomes the device demonstrated.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Ninety-one (91) total subjects were included in the global analysis.
• Data Provenance: Data were collected from three sources: the EASE Study, the EASE-2 Study, and the EU Post-Market Study (4F cohort).
  • Countries of Origin: Paraguay (EASE and EASE-2), Germany, and the United Kingdom (EU Post-Market Study).
  • Type of Study: Clinical studies. The text states "Data from three sources... was collected and analyzed." This implies prospective collection for the original studies but analyzed retrospectively as a pooled global analysis for this submission.

3. Number of Experts and Qualifications for Ground Truth

• The document does not describe details about a "ground truth" establishment by experts in the context of an AI/ML algorithm or image interpretation.
• For clinical outcomes, procedural success was confirmed intraoperatively with fistulography or postoperative duplex ultrasonography. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC). The qualifications of these individuals are not specified beyond their roles.

4. Adjudication Method for the Test Set

• For adverse events, "Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC)." This implies a form of expert review and adjudication for adverse event reporting, but not in the context of establishing a truth standard for an AI algorithm's output.

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

• No, this was not an MRMC study and AI assistance was not involved. The study focused on the clinical performance of a medical device (WavelinQ™ 4F EndoAVF System) for creating AVFs, not on evaluating human readers' performance with or without AI assistance.

6. Standalone Performance

• Not applicable for an AI algorithm. This document describes the performance of a physical medical device. The "performance data" presented are the clinical outcomes of using the device in patients, not the performance of a standalone algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the device's performance is based on clinical outcomes observed in patients, confirmed by standard medical procedures (e.g., fistulography, duplex ultrasonography for success, and independent review for safety events). It is not pathology or expert consensus on image interpretation for an AI system.

8. Sample Size for the Training Set

• Not applicable. This document describes a clinical study of a medical device, not the development or training of an AI algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable. This document describes a clinical study of a medical device, not the development or training of an AI algorithm.

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