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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The subject MectaLIF Extension implants are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671 and K181970) and MectaLIF Oblique and Posterior TiPEEK implants (K133192 and K181970). MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject MectaLIF Extension includes various sizes of MectaLIF Oblique and MectaLIF Posterior implants with different widths, lengths, heights, and lordosis angles. The implants are made of implant grade Polyetherketone and have markers made of Tantalum. The devices are available both uncoated or coated with commercially pure titanium coating.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MectaLIF Extension device.

It's important to note that the document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within this context of demonstrating equivalence through non-clinical performance data rather than a full-scale clinical trial.

Acceptance Criteria and Device Performance for MectaLIF Extension (Based on 510(k) Summary)

Based on the provided FDA 510(k) summary (K212831), the "acceptance criteria" for the MectaLIF Extension are implicitly tied to demonstrating performance comparable to its predicate devices, aligning with relevant ASTM and ISO standards for intervertebral body fusion devices. The study proving these criteria are met consists primarily of non-clinical (benchtop) performance testing. No clinical studies were conducted for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

• Static and dynamic shear compression test (ASTM F2077-18)
• Axial compressive subsidence test (ASTM F2077-18)
• Measuring Load Induced subsidence (ASTM F2267-04)
• Expulsion Test rationale (Implied adherence to performance requirements) | Design validation and performance testing conducted to written protocols. Implied to meet or exceed relevant predicate device and standard requirements. |
  | Material Properties & Coating Performance | - TiPEEK coating validation (ASTM F1854-15 for stereological evaluation of porous coatings; ASTM F1147-05 for tension testing)
• Wear analysis of TiPEEK coated devices (ISO 17853:2011; ASTM F1877-16) | Adherence to relevant ASTM and ISO standards for material and coating validation. Implied acceptable performance. |
  | Biocompatibility & Sterility | - Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter )
• Pyrogen test according to USP chapter
• Biocompatibility assessment (General statement, implying tests like cytotoxicity, sensitization, irritation performed per ISO 10993)
• Sterility Validation | Tests were conducted. Devices are not labeled as non-pyrogenic. Implied to meet biocompatibility and sterility requirements. |
  | Shelf-Life & Packaging | - Shelf-life evaluation
• Packaging validation | Evaluation/validation done. Implied acceptable. |
  | Design Integrity (New Sizes/Lordosis/Volume) | - Design Validation Report for MectaLIF Oblique 10mm width instrument/implant interface (specific to one of the new configurations, implies assessment of fit, function, and instrument compatibility for new sizes/lordosis) | Conducted as part of design validation to written protocols. Implied suitable. |

Note: The document states that "Based on the risk analysis, design validation and performance testing were conducted to written protocols." and lists the specific tests. The detailed quantitative results (e.g., exact load values survived, specific wear rates) are not included in this public summary but would be part of the full 510(k) submission. The "reported device performance" in this context is the statement that these tests were conducted and support the claim of substantial equivalence.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of devices tested) for each non-clinical performance test (e.g., how many cages underwent axial compression testing). These numbers are typically defined by the specific ASTM/ISO standards referenced.
• Data Provenance: The tests are explicitly non-clinical (benchtop mechanical, material, and biological tests).
  • Country of Origin: The submitter is "Medacta International SA, Strada Regina 6874 Castel San Pietro (CH) Switzerland." The testing would presumably have been performed in a lab accredited to conduct these tests, likely in Switzerland or a country with recognized testing facilities.
  • Retrospective or Prospective: Not applicable as these are benchtop tests, not clinical data from patients.

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

This concept is not applicable in this context. For a 510(k) submission primarily relying on non-clinical performance data, there is no "ground truth" derived from expert clinical opinion or patient outcomes in the same way there would be for an AI/CADe device submitting clinical study results. The "ground truth" for non-clinical tests is established by:

• The measurement equipment and its calibration.
• The test methods defined by recognized standards (e.g., ASTM, ISO), which dictate how a device's performance characteristic is measured.
• The acceptance criteria set by the manufacturer (and implicitly accepted by the FDA for substantial equivalence) based on predicate device performance and standard requirements.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic accuracy or image review, to resolve discrepancies between readers or to establish a definitive diagnosis as ground truth. Since this submission relies on non-clinical benchtop testing, there are no human readers or clinical cases requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Studies: No clinical studies were conducted." This type of study would be relevant for a device intended to aid in clinical diagnosis or treatment decisions by human readers, typically for AI/CADe.

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

No, a standalone performance evaluation (as defined for AI algorithms) was not done. This device is an intervertebral body fusion implant, not software or an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for determining acceptance for this device is based on:

• Engineering Standards and Specifications: Adherence to defined physical and mechanical properties, material composition, and dimensions as tested against industry standards (ASTM F2077, F2267, F1854, F1147) and biocompatibility standards (ISO, USP, European Pharmacopoeia).
• Predicate Device Equivalence: The primary "ground truth" for a 510(k) clearance is demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device regarding safety and effectiveness. This means the performance characteristics of the new device are comparable to, or better than, the predicate devices based on the non-clinical tests.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical implant, not an AI/ML algorithm.

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

This concept is not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm requiring a training set and associated ground truth establishment.

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Peridot Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Peridot Intervertebral Body Fusion System is intervertebral body fixation devices intended for use as an aid in spinal fixation. The Peridot Intervertebral fusion system is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.

X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.

The device is available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

The device is supplied non-sterile.

The device consists of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.

The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device and instrument are supplied separately.

The device must be used in combination with the dedicated instrument supplied.

The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.

This document is a 510(k) premarket notification for a medical device called the "Peridot Intervertebral body fusion system." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting the performance of an AI/ML powered device against acceptance criteria.

The document does not contain any information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.

Instead, it describes the device, its intended use, and compares it to existing predicate devices to show substantial equivalence for regulatory clearance. It focuses on mechanical testing of the physical implant according to ASTM standards, not on the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

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The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).

Patients should have six months of non-operative treatment prior to surgery.

These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.

These implants are intended for use with Biedermann Motech supplemental internal fixation products.

The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:

The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.

Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.

The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.

The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.

This document is a 510(k) premarket notification for a medical device (TELIX K Interbody System), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially points 2, 3, 4, 5, 6, 7, 8, 9 which relate to data, ground truth establishment, and clinical studies) are not applicable or not present in this type of regulatory submission. This document describes a physical intervertebral body fusion device, not an AI or algorithm.

Here's an analysis based on the provided text, addressing only the applicable points:

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

Based on the document, the "acceptance criteria" are derived from relevant ASTM standards for intervertebral body fusion devices, and the "reported device performance" refers to the results of mechanical bench testing.

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

• Sample Size: Not explicitly stated for specific tests, but implies a sufficient number of samples were tested to meet ASTM standard requirements for substantiation.
• Data Provenance: Not applicable in terms of patient data. The data is from mechanical bench testing of the device components.

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

• Not applicable. This relates to mechanical testing against standards, not expert-derived ground truth on patient data.

4. Adjudication method for the test set:

• Not applicable. This relates to mechanical testing governed by standardized protocols, not human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This document refers to a physical implant and mechanical testing, not a diagnostic or AI-assisted device.

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:

• For the mechanical bench testing, the "ground truth" is defined by the acceptance limits and methodologies of the ASTM standards (ASTM F2077-14 and ASTM F2267-04).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device subject to mechanical testing, not an AI/algorithm.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary based on the document:

The provided document describes a 510(k) premarket notification for a physical medical device, the TELIX K Interbody System. The intent of this submission is to demonstrate substantial equivalence to an already legally marketed device, primarily through non-clinical bench testing to ensure mechanical performance aligns with established standards for intervertebral body fusion devices.

The "acceptance criteria" are implied by the referenced ASTM standards (ASTM F2077-14 and ASTM F2267-04), which dictate the performance requirements for such implants regarding static compression, dynamic compression, torsion, compression-shear, and subsidence. The study conducted was non-clinical bench testing, specifically mechanical tests. No clinical trials or studies involving human patients were performed or deemed necessary for this 510(k) submission ("No clinical tests were performed."). Therefore, concepts like data provenance from patient studies, expert consensus, MRMC studies, or training sets for AI algorithms are not relevant to this specific regulatory submission.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The Mecta-C Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C intervertebral body fusion devices consist of a PEEK (Polyetheretherketone) body and tantalum markers. The markers are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The provided text describes a 510(k) premarket notification for the Mecta-C Intervertebral Body Fusion Device. This type of submission relies on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies with human participants or AI performance metrics. Therefore, many of the requested criteria related to studies involving AI, human readers, ground truth establishment for clinical data, and specific sample sizes for training/test sets are not applicable to this document.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The Mecta-C device aims to demonstrate "similar" or "substantially equivalent" mechanical performance according to specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of mechanical performance tests conducted according to established ASTM standards. These tests compare the Mecta-C Intervertebral Body Fusion Device to identified predicate devices (Vu cPOD and Bengal Cage).

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

• Sample Size for Test Set: The document does not specify the exact number of Mecta-C devices or predicate devices used in each mechanical test. Mechanical testing typically involves multiple samples (e.g., 5-10 per test condition) to ensure statistical significance, but these details are not provided in this 510(k) summary.
• Data Provenance: The data provenance is from mechanical laboratory testing, not human or clinical data. The tests were performed to ASTM standards, which are international standards. The country where the testing took place is not explicitly stated, but Medacta International SA is based in Switzerland and Medacta USA is in California.

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

• Not Applicable. For mechanical testing of medical devices, "ground truth" is established by the physical properties and performance characteristics of the predicate devices and the specifications of the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's ambiguity in human interpretation of data. For mechanical tests, the results are quantitative measurements against predefined criteria in the ASTM standards.

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

• No. This is a mechanical device submission, not an AI or imaging diagnostic device. MRMC studies analyze human reader performance, often in conjunction with AI.

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

• No. This refers to AI algorithm performance. This submission is for a physical implantable device.

7. The Type of Ground Truth Used:

• Objective Mechanical Performance Data: The "ground truth" in this context is the quantitative mechanical performance data obtained from testing both the Mecta-C device and the predicate devices according to established ASTM standards (ASTM F2077 for various compression/shear/torsion tests and ASTM F2267 for subsidence). The FDA's acceptance of "substantial equivalence" relies on the Mecta-C device's performance falling within acceptable limits relative to these predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence. This concept applies to machine learning algorithms.

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

• Not Applicable. See point 8.

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