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The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space for the treatment of cervical degenerative disc discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies) using autograft bone.

Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.

The Arcadius X C spinal system is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy procedures. The system consists of a PEEK cage and two bone screws. The PEEK cages are manufactured from a radiolucent material medical grade LT1 polyetheretherketone (PEEK) per ASTM F2026, with a titanium layer and a vacuum titanium plasma spray coating (PlasmaporeXP). The Arcadius N C implants are offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients. The Arcadius C implant is available in two footprints. The wide central opening holds optimal graft material. The screws are 4mm in diameter and offered in three lengths. The fixation screws and radiographic markers are manufactured of titanium alloy, (Ti6Al4V) according to ISO 5832/3.

The provided text is a 510(k) Summary for the Arcadius C Spinal System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing. It does not contain information about studies involving human readers, AI assistance, or the establishment of ground truth for a test set in the context of diagnostic or interpretive tasks.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered:

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

The document states that the Arcadius C Spinal System "meets or exceeds the performance of the predicate devices" for various tests. However, it does not provide specific acceptance criteria (e.g., minimum load values, maximum wear rates) or detailed reported device performance values for these tests. It only lists the types of tests performed.

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

Not applicable. This document describes non-clinical (mechanical) testing of a medical implant, not a study involving a test set of data (like images or patient records) for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for non-clinical mechanical testing is established by measurement instruments and scientific standards, not human experts.

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

Not applicable.

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

Not applicable. This is not an AI or diagnostic device.

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

Not applicable.

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

For the non-clinical performance data, the "ground truth" is based on established ASTM standards and methodologies for mechanical testing of implants, utilizing precise measurement devices and engineering principles.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable.

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The Plasmapore® XP Spinal Implant System are indicated 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 involved levels. These patients may have had previous non-fusion surgery at the involved spinal level(s). The Plasmapore® XP Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The Plasmapore® XP Spinal Implants can be used individually or in pairs. The Plasmapore® XP Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regiment of non-operative treatment prior to being treated with the device.

The Plasmapore® XP Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK – Optima (per ASTM F2026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have titanium alloy (TiAl6V4) radiographic markers per ISO 5832-3.

The provided document, K132421, describes the 510(k) premarket notification for the Plasmapore® XP Spinal Implant System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or related ground truth establishment, expert consensus, or multi-reader multi-case studies.

Therefore, the following information is extracted directly from the provided text, and many of the requested sections related to AI performance, human user studies, and ground truth are not applicable or not present in this type of submission.

Acceptance Criteria and Device Performance

The device's premarket submission is based on demonstrating substantial equivalence to existing predicate devices through a series of non-clinical, laboratory performance tests. The acceptance criteria are implicitly that the Plasmapore® XP Spinal Implant System "meets or exceeds the performance of the predicate devices" for the tested parameters.

Study Details

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

   • This submission describes non-clinical (laboratory) testing of the device, not a human clinical study or AI algorithm test set. Therefore, there is no "test set" of patient data in the context of an AI algorithm or clinical trial. The "samples" would typically refer to physical device specimens tested in a laboratory. The document does not specify the number of device samples used for each test.
   • Data Provenance: Not applicable as it refers to non-clinical laboratory testing. The testing was performed by Aesculap, an American company (or its affiliates under the Aesculap brand), suggesting the data originates from their internal testing or third-party labs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. Ground truth in this context is established by standardized laboratory testing methods (ASTM and ISO standards) and the physical properties/performance of the device specimens, rather than human expert interpretation of data.

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

   • Not applicable. This pertains to non-clinical laboratory testing.

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 submission concerns a physical medical device (spinal implant), not an AI-assisted diagnostic or interpretative system.

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

   • Not applicable. This submission concerns a physical medical device, not an AI algorithm.

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

   • The "ground truth" for this device's performance is derived from standardized physical and mechanical testing protocols (ASTM and ISO standards) applied to device specimens in a laboratory setting. The acceptability is determined by meeting or exceeding the performance thresholds of the predicate devices under these controlled conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm. There is no "training set" in this context.

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

   • Not applicable. This is not an AI algorithm.

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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2) spondylolisthesis,
3) trauma (i.e., fracture or dislocation),
4) spinal stenosis,
5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6) tumor.
7) pseudoarthrosis, and
8) failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, staples, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided text describes a 510(k) premarket notification for the "S4 Spinal System Modification Dual Rod Extension." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, rather than a clinical study with acceptance criteria measuring device performance on patients or human readers.

Therefore, many of the requested sections are not applicable to the information contained within this 510(k) summary.

Here's a breakdown of what can be extracted and what information is not present:

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

Study that proves the device meets the acceptance criteria:
Non-clinical testing was performed according to FDA Guidance for Spinal System 510(k)'s. This included:

• Static Axial Compression per ASTM 1717-12
• Dynamic Axial Compression per ASTM F1717-12
• Static Torsion per ASTM 1717-12

The results of these studies showed that the subject S4 Staples "meet or exceed the performance of the predicate devices," thereby demonstrating substantial equivalence.

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 testing described is non-clinical (mechanical bench testing), and typically, the sample sizes for such tests are reported as the number of devices or test specimens, not patient data. Data provenance (country of origin, retrospective/prospective) is also not applicable for non-clinical bench testing.

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 is not applicable. The "ground truth" for non-clinical mechanical testing is typically the measured mechanical properties against established standards or predicate device performance, not expert consensus on clinical findings.

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

This is not applicable. Adjudication methods are relevant for clinical studies where subjective assessments (e.g., image interpretation) require consensus among experts. This document describes non-clinical 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

This is not applicable. This document describes a medical device (spinal implant) and its non-clinical mechanical performance. There is no mention of AI, human readers, or clinical effectiveness studies in an MRMC format.

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

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

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

The "ground truth" for this non-clinical study is the mechanical performance of the predicate devices and established ASTM standards (ASTM 1717-12). The S4 Staples' performance was compared against these benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" mentioned or implied in the context of this non-clinical mechanical performance testing for a spinal implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable as there is no training set.

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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

2. spondylolisthesis,

3. trauma (i.e., fracture or dislocation),

4. spinal stenosis,

5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

6. tumor,

7. pseudoarthrosis, and

8. failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided text describes a 510(k) premarket notification for the Aesculap® Implant Systems S4 Spinal System, specifically focusing on a line extension to include additional rod connectors. The evaluation largely relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study described, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a "sample size" in the context of clinical test subjects or datasets as would be common for AI/diagnostic device studies. Instead, it refers to non-clinical testing of the physical device components. The sample size for these non-clinical tests (e.g., number of rod connectors tested) is not provided.
• Data Provenance: Not applicable in the context of clinical data provenance. The "data" here comes from laboratory mechanical testing of physical devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This submission is for a physical spinal implant system, not a diagnostic or AI-driven device requiring expert consensus for ground truth establishment. The "truth" in this context is determined by adherence to ASTM standards and mechanical performance metrics compared to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The performance is assessed through standardized mechanical testing methods per ASTM F1717-11a.

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

• Not applicable. This is a spinal implant, not a diagnostic imaging or AI-assisted interpretation device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This submission describes a physical medical device, not an algorithm or software.

7. Type of Ground Truth Used:

• For the performance studies, the "ground truth" implicitly refers to the specified performance criteria set by ASTM standards (F1717-11a) for static axial compression bending, dynamic axial compression bending, and static torsion, as well as the performance profiles of legally marketed predicate devices. The device's performance is compared against these benchmarks rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary: The provided document describes the regulatory pathway for a spinal implant system, which primarily involves demonstrating mechanical equivalence to predicate devices through standardized non-clinical testing. It does not involve AI, diagnostic algorithms, or human-in-the-loop performance studies.

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The AIS SIBD XP Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplemental fixation is used.

As an intervertebral body fusion device designed for use with autograft, the SIBD XP Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).

Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.

The AIS SIBD XP Spinal System is an implantable spinal device manufactured from PEEK-OPTIMA® LT (Polyetheretherketone) per ASTM F2026, with a titanium laver and a vacuum plasma spray coating (Plasmapore®). The device will have Tantalum markers per ASTM F-560.The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.

This is a medical device submission, not an AI/ML device, so many of the requested fields are not applicable. Here's what can be extracted:

Acceptance Criteria and Device Performance Study

The submission describes the Aesculap® Implant Systems (AIS) - SIBD XP Spinal System as a substantially equivalent device to its predicate. The "acceptance criteria" are implied by the performance of the predicate devices and existing ASTM standards. The study performed is a series of non-clinical tests to demonstrate that the new device meets or exceeds these established performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. Standard practice for these types of mechanical tests would typically involve a small number of samples (e.g., 5-10 per test condition) to establish statistical significance within the test's scope.
• Data Provenance: Not explicitly stated, but these are non-clinical tests, meaning they were conducted in a laboratory setting. Not applicable to country of origin or retrospective/prospective in the conventional sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is for a physical implant device and involves mechanical and material testing, not expert review of diagnostic interpretations. The "ground truth" is defined by established engineering and material science standards (ASTM).

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical tests are evaluated against predefined acceptance limits set by ASTM standards and comparison to predicate devices, not by human adjudication of ambiguous results.

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

• Not Applicable. This is a mechanical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a mechanical device, not an AI algorithm.

7. Type of Ground Truth Used

• Engineering and Material Standards: The ground truth is established by recognized industry standards, specifically ASTM (American Society for Testing and Materials) standards for spinal implants and coating characteristics. The performance is also benchmarked against legally marketed predicate devices.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, and the concept of a "training set" is not relevant here. The design of the device is based on established engineering principles and prior validated devices.

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

• Not Applicable. As there is no training set, this question is not relevant. The device's design is informed by existing knowledge, predicate devices, and regulatory requirements rather than a data-driven training process.

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The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile and or sterile.

The provided documentation describes a medical device, the "Aesculap Implant Systems Laminoplasty Plating System," which underwent a 510(k) premarket notification. This submission relies on performance data from in vitro testing rather than clinical studies or AI/algorithm performance. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for AI, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Performance: The device's performance was measured against the standards set by ASTM F2193 (for static and dynamic bending) and ASTM F543 (for screw pull-out). The submission states that the testing results demonstrate the device is "safe and effective comparable to other predicate systems currently on the market," implying that it met or exceeded the performance of these predicates under the specified tests. Specific numerical values for the acceptance criteria or the device's performance are not provided in this summary.

Regarding AI-specific questions (not applicable to this device submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. This device relies on in vitro mechanical testing, not a data-driven algorithm with a "test set" 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. Ground truth for in vitro mechanical testing is based on engineering principles and measurements rather than expert human interpretation of medical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No AI component.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component.
• 7. The type of ground truth used: For this device, the "ground truth" for demonstrating safety and effectiveness comes from the engineering principles and material science underlying the ASTM standards (F2193 and F543). The outcome measures are physical properties (e.g., bending strength, pull-out force) measured directly, rather than medical observations.
• 8. The sample size for the training set: Not applicable. No AI component.
• 9. How the ground truth for the training set was established: Not applicable. No AI component.

Summary of the Study and Device Approval:

The "study" in this context refers to the performance testing conducted according to recognized industry standards (ASTM F2193 and F543).

• Study Type: In vitro mechanical testing.
• Purpose: To demonstrate the mechanical safety and effectiveness of the AIS Laminoplasty Plating System.
• Methodology: The system underwent static bending, dynamic bending, and screw pull-out testing.
• Result: The testing reportedly demonstrated that the device is "safe and effective comparable to other predicate systems currently on the market." This comparison implies that the device performed equivalently to, or better than, legally marketed predicate devices that have established safety and effectiveness.
• Clinical Testing: No clinical testing was performed for this submission; the 510(k) relies solely on the in vitro performance data and substantial equivalence to predicates (AIS Laminoplasty Plating System (K090354) and Synthes AFS (K032534)) based on material, design, function, and intended use.

This 510(k) clearance (K103284) was granted based on the demonstration of substantial equivalence to predicate devices through in vitro performance testing, rather than through clinical trials or AI algorithm validation.

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The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used.

As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).

Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.

The Aesculap® Implant Systems SIBD Spinal System is an implantable spinal device manufactured from polyetheretherketone (PEEK) with tantalum markers. The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.

The provided text describes a medical device, the Aesculap® Implant Systems SIBD Spinal System, and its clearance process. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving device performance.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for a new, novel device. The "performance data" section primarily refers to mechanical testing.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it refers to mechanical testing standards and states that the device is "safe and effective."

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

This information is not present in the provided document. The performance data discussed is related to mechanical testing, not a clinical test set on patients.

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 present. The document doesn't describe a clinical study involving experts establishing ground truth for a test set.

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

This information is not present. No clinical test set with adjudication is described.

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

There is no mention of an MRMC study or AI in this document. This device is a physical spinal implant, not an AI/software device.

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

This information is not applicable/present. This is a physical implant, not an algorithm.

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

For the mechanical testing, the "ground truth" would be the parameters defined by the ASTM F2077/F2267 standards. For the overall device, the "ground truth" for FDA clearance is its substantial equivalence to existing predicate devices, implying similar safety and effectiveness profiles as established by the predicate devices' past performance and regulatory history. There is no specific, independent "ground truth" derived from patient data described for this 510(k) submission.

8. The sample size for the training set

This information is not present. There is no "training set" in the context of this 510(k) summary for a physical implant.

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

This information is not present/applicable.

Summary of what the document shows:

The document provides a 510(k) summary for a spinal implant system. The primary method for demonstrating its "safety and effectiveness" and meeting "acceptance criteria" (though not explicitly called that) is by showing:

• Substantial Equivalence: The device is similar in materials, design, and intended use to several already FDA-cleared predicate devices.
• Mechanical Testing: The device successfully passed standard mechanical tests (ASTM F2077/F2267) relevant to spinal implants.

This type of submission typically relies on non-clinical data and comparison to predicates, rather than extensive, new clinical performance studies with defined acceptance criteria and ground truth derived from patient data.

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The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion. Patients with acute femoral neck fractures. The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without u-CaP®.

The Excia M and ML femoral stem are available in one design. The femoral stem is manufactured from TI with a plasma spray coating (Plasmapore) with U-CaP®. The Excia M and ML femoral stem will be offered in an 8/10 or 12/14 taper. This component is intended for uncemented use.

The provided text is a 510(k) summary for the Excia Total Hip System M and ML Femoral Stem. It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria.

Instead, the "Performance Data" section states that:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."
• It lists several other guidance documents for orthopedic implant testing that were followed.

This indicates that the device underwent a battery of standardized tests required by the FDA for orthopedic implants. However, the document does not present:

• A table of specific acceptance criteria (e.g., minimum fatigue strength, maximum wear rate).
• Any reported device performance against such specific criteria.
• Details about a clinical study with human subjects or a comparison to AI.

Therefore, I cannot provide the requested information for the following points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated.
2. Sample size used for the test set and the data provenance: Not mentioned. The testing refers to physical/mechanical performance rather than clinical 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 is related to mechanical testing, not expert-adjudicated clinical data.
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 device 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: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the testing described is mechanical.
8. The sample size for the training set: Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document indicates that the Excia Total Hip System M and ML Femoral Stem met necessary performance data requirements by undergoing various mechanical and material tests in accordance with FDA guidance documents for orthopedic devices. However, it does not specify the exact performance metrics or acceptance criteria for those tests, nor does it describe any studies involving human subjects, AI systems, or expert consensus adjudication. This 510(k) emphasizes substantial equivalence based on material, design, and indications for use, supported by adherence to recognized testing standards for physical implants.

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The MILI System is intended for posterior, non-cervical pedicle fixation of the spine. It is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of one or more of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolithesis (Grade I/II) with objective evidence of neurological impairment, fracture, dislocation, scoliosis (one level), kyphosis, spinal tumor, failed previous fusion (pseudarthrosis),

The MILI System, when used as a pedicle screw fixation system, is indicated for use in patients: a) who are receiving fusion using autogenous graft only; b) who are having the device fixed or attached to the thoracolumbar or sacral spine; and c) who are having the device removed after the development of a solid fusion mass.

The MILI System is indicated only for one-level or adjacent two-level procedures.

The Aesculap Implant Systems (AIS) MILI System is a minimally invasive posterior plating system for the thoracolumbar spine. This system is intended for posterior, non-cervical pedicle fixation. The AIS MILI System consists of plates and cannulated screws. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS MILI System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MILI (Minimally Invasive Lumbar Implant) System:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document explicitly mentions "cadaver testing," which indicates a biological, non-human live subject sample. However, the exact number of cadavers used is not specified.
• Data Provenance: The document does not specify the country of origin for the biomechanical or cadaver testing. It also doesn't indicate if the data was retrospective or prospective, though cadaver testing would inherently be prospective for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set in the context of expert consensus or clinical outcomes. The cadaver testing focuses on surgical implantation feasibility, which would likely be assessed by surgeons or anatomists, but their specific roles and numbers are not detailed.

4. Adjudication Method (Test Set)

• The document does not specify an adjudication method. For cadaver testing, methods like 2+1 or 3+1 are typically for clinical outcome or image interpretation, which isn't the focus here.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The evaluations are focused on the device's physical and mechanical properties and surgical feasibility, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The MILI System is a physical implant, not an AI algorithm. Therefore, there is no standalone (algorithm-only) performance study described.

7. Type of Ground Truth Used

• The ground truth in this context is primarily established through mechanical/physical testing results demonstrating equivalence to predicate devices and observational assessment (cadaver testing) of the device's ability to be implanted successfully according to its intended technique. It is not based on expert consensus for clinical diagnosis, pathology, or long-term outcomes data in live patients for these performance tests.

8. Sample Size for the Training Set

• Not applicable. As the MILI System is a physical medical device (implant) and not an AI/machine learning algorithm, there is no "training set" in the context of data-driven model development. The design and manufacturing process for the device would have involved engineering design, material testing, and rapid prototyping, but these are not considered a "training set" in the same way as for AI.

9. How Ground Truth for the Training Set Was Established

• Not applicable. Refer to point 8. There is no training set in the AI sense for this device. The "ground truth" for its design and performance would be established through engineering principles, material science, biomechanical standards, and iterative design and testing.

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When used as a Vertebral Body Replacement Device:

The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.

When used as an Intervertebral Body Fusion System:

The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) 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. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.

The Aesculap CeSpace PEEK Spinal Implant System is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).

The provided text describes the regulatory clearance for the Aesculap CeSpace PEEK Spinal Implant System, which is a medical device. As such, the "acceptance criteria" and "device performance" discussed here refer to the mechanical and material performance of the implant, not to the performance of an AI-powered diagnostic device or algorithm. Therefore, many of the questions regarding AI-specific criteria (like AI-assisted improvement, standalone AI performance, training set details, or ground truth for diagnostic imaging) are not applicable to this document.

Here's an analysis of the provided text based on the questions:

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

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. For mechanical testing of medical implants, the "test set" would refer to the physical implants or simulated constructs tested. The text only states that static and dynamic testing was "performed."

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 to this type of device and testing. "Ground truth" in this context would refer to the established mechanical properties of the material and the device's ability to withstand forces, which are determined by engineering standards and laboratory testing, not by expert consensus in a clinical or image interpretation setting.

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

This information is not applicable to this type of device and testing. Adjudication methods typically relate to disagreements in human interpretation of data, which is not relevant 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

This information is not applicable as this is a physical medical implant, not an AI-powered diagnostic system.

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

This information is not applicable as this is a physical medical implant, not an AI-powered algorithm.

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

For this device, the "ground truth" for proving its performance is established by engineering standards and specifications. Specifically:

• ASTM F2077: Standard Test Methods for Intervertebral Body Fusion Devices
• ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (possibly, or a related standard for spinal fixation)
• ASTM F2026: Standard Specification for PEEK polymers (for material compliance)
• FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device: This document outlines specific recommendations and acceptance criteria for testing these devices.

The device's performance is measured against these established mechanical and material property standards.

8. The sample size for the training set

This information is not applicable. This is a physical medical implant, not an AI model.

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

This information is not applicable. This is a physical medical implant, not an AI model.

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