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The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ System hooks, APEX® System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.

In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy during surgery. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The provided text describes a 510(k) premarket notification for the "Vitality® Spinal Fixation System" and its substantial equivalence to predicate devices. It focuses on mechanical testing to demonstrate substantial equivalence for a medical device (spinal fixation system), not an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are typical for AI/ML device evaluations, are not present.

However, based on the provided text, I can extract the following information regarding the performance study:

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

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

• Sample Size: Not specified. The document refers to "mechanical testing of the modified screw implants" but does not quantify the number of screws or tests performed.
• Data Provenance: Not applicable in the traditional sense for AI/ML. The "data" here refers to the outcomes of physical mechanical tests.

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

• Not applicable. This is a mechanical device, not an AI/ML device requiring human expert ground truth. The "ground truth" is established by the predefined ASTM standards and the physical properties of the materials and design.

4. Adjudication method for the test set:

• Not applicable. As a mechanical device study, there is no expert adjudication process. The results are based on objective measurements against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation, which is not the function of a spinal fixation system.

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

• Not applicable in the context of AI/ML algorithms. The device itself (the spinal fixation system) is standalone in its mechanical function, but "standalone performance" usually refers to an AI algorithm operating without human intervention.

7. The type of ground truth used:

• Engineering Standards: The ground truth for performance is based on established engineering standards (ASTM F1717 and ASTM F1798) for spinal implant mechanical testing. These standards define the acceptable performance parameters.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device design and manufacturing processes are informed by engineering principles and previous designs, not by a data-driven training set.

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

• Not applicable. As there's no training set for an AI/ML algorithm, this question is irrelevant to this device.

In summary, the provided document describes a 510(k) submission for a spinal fixation system, focusing on demonstrating substantial equivalence through mechanical testing against established ASTM standards. It does not pertain to an AI/ML device, and thus, many of the questions related to AI/ML specific evaluation criteria are not applicable.

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The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions for use.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should hot be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Hooks, and Universal Clamp® Spinal Fixation System.

The provided document pertains to a 510(k) premarket notification for a medical device, specifically the Vitality® Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be seen for a novel AI/software medical device.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this submission. The document explicitly states:

• "To support substantial equivalence, mechanical testing of the modified screw implants of the subject Vitality® Spinal Fixation System were assessed and tested appropriately in accordance with ASTM standards. Performance testing included tests per ASTM F1717 (dynamic compression bending) and demonstrated the subject devices are safe and effective for use with pedicle screw fixation. In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)."
• "The subject Vitality® Spinal Fixation System is substantially equivalent to the Vitality® Spinal Fixation System (K171907)."
• "Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates."

This means the "acceptance criteria" and "study" are primarily focused on mechanical performance testing against established ASTM standards and demonstrating substantial equivalence to a previously cleared device (Vitality® Spinal Fixation System, K171907). There is no mention of an AI algorithm, human readers, or clinical performance studies with ground truth in the context of this submission.

Here's how to address the request based on the provided text:

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

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

The document mentions "mechanical testing of the modified screw implants."

• Sample size: Not explicitly stated (e.g., number of screws, number of tests performed). It refers to "the modified screw implants" generally.
• Data provenance: Lab-generated data from mechanical testing according to ASTM standards for medical devices (product testing). Not applicable to country of origin, retrospective/prospective in the clinical sense.

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

Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test results rather than expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. Mechanical testing results are objective measurements against a standard.

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

Not applicable. This device is a mechanical implant; no AI component or human reader studies are mentioned.

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

Not applicable. This device is a mechanical implant; no AI algorithm is involved.

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

For mechanical testing, the "ground truth" would be the pass/fail criteria defined by the ASTM F1717 standard (e.g., maximum force before failure, displacement at yield, fatigue life cycles) for the specific type of spinal fixation device.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This is a mechanical device, not a machine learning algorithm.

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The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.

Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The Vitality®+ Power Instrument System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The system includes reusable Vitality drills, taps, drivers and adapters to be used with an electric handpiece. The subject instruments are compatible for use with the Vitality® Spinal Fixation System implants.

The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.

The FDA 510(k) summary for the Vitality® Spinal Fixation System and Vitality®+ Power Instrument System describes non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics for an AI device. The document pertains to a medical device for spinal fixation, explicitly mentioning implants, instruments, and surgical techniques, not an AI or algorithm-based system.

Therefore, many of the requested categories related to AI performance metrics (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this document. The provided text does not contain information on an AI device.

However, I can extract the information relevant to the non-clinical testing performed for the substantial equivalence determination of the Vitality® Spinal Fixation System and Vitality®+ Power Instrument System.

Acceptance Criteria and Device Performance for Vitality® Spinal Fixation System & Vitality®+ Power Instrument System:

• Clinical Literature Assessment |
  | Intended Use/Indications for Use | The Vitality® Spinal Fixation System is a non-cervical spinal fixation device for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5) in skeletally mature and adolescent patients. It is an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, and/or failed previous fusion. Also indicated for severe spondylolisthesis (Grade 3 and 4) of L5-S1. Pediatric pedicle screw fixation is limited to a posterior approach for adolescent idiopathic scoliosis.

The Vitality®+ Power Instrument System is intended for use with the Zimmer Biomet Universal Power System to facilitate preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique in non-cervical spine procedures (open and minimally invasive). |
| Materials | Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Instruments are reusable. |
| Sterility | Assumed to meet industry standards as part of overall substantial equivalence, though not explicitly detailed with specific data in this summary. |
| Manufacturing Methods | Same or similar to predicate devices. |
| Operational Principles | Substantially equivalent to predicate devices. |

Additional Information (where applicable based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing for a physical medical device, not an AI algorithm evaluated on a data test set. The tests mentioned are "Cadaveric Testing" and "Clinical Literature Assessment," but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided for these.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the evaluation of an AI device with a ground truth established by experts.
3. Adjudication method for the test set: Not applicable. No adjudication method for an AI test set is described.
4. 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 not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The concept of "ground truth" in the context of AI evaluation does not apply to this device. The evaluation focuses on physical performance and substantial equivalence to existing devices.
7. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable. This document describes a physical medical device, not an AI algorithm.

Ask a specific question about this device

The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The provided document is a 510(k) premarket notification letter from the FDA to Zimmer Biomet Spine, Inc., regarding the Vitality® Spinal Fixation System. It confirms the device's substantial equivalence to previously marketed predicate devices.

However, the document does not contain specific acceptance criteria, reported device performance data in a table format, or details about a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not part of this FDA clearance letter.

The "Performance Data" section in the 510(k) summary only mentions mechanical testing of the modified screw implants against ASTM standards (ASTM F1798 and ASTM F1717) to support substantial equivalence. It states: "In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria were met, specifically regarding clinical or diagnostic performance, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what can be extracted or inferred from the document regarding its performance aspects:

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

   • Acceptance Criteria (Inferred from mechanical testing standards): The device (specifically, modified screw implants) must meet the performance requirements stipulated by ASTM F1798 (axial grip strength, torsional grip strength, and flexion/extension moment grip strength) and ASTM F1717 (static compression bending, dynamic compression bending, and static torsion). These standards define the expected mechanical properties and limits for spinal fixation devices.
   • Reported Device Performance: "In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)." This indicates that the device met the mechanical performance requirements of the specified ASTM standards and was comparable to the predicate.

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

   • The document does not specify the number of samples (e.g., individual screws) used in the mechanical tests.
   • Data provenance is not mentioned, as these are in vitro mechanical tests, not clinical studies with patient data.

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

   • Not applicable as this document describes mechanical performance testing, not a diagnostic or clinical efficacy study requiring expert review or ground truth labeling by medical professionals.

4. Adjudication method for the test set:

   • Not applicable for mechanical testing.

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

   • Not applicable. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool or imaging device.

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

   • Not applicable. This is a mechanical device.

7. The type of ground truth used:

   • For the mechanical tests, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM F1798 and ASTM F1717 standards.

8. The sample size for the training set:

   • Not applicable, as this is a mechanical device and not an AI/machine learning system that requires a "training set."

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

   • Not applicable.

In summary, the provided FDA letter confirms mechanical substantial equivalence but does not offer the details of a clinical or diagnostic performance study as requested in the prompt.

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