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The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following:

1. Osteoarthritis
2. Rheumatoid arthritis
3. Tumor conditions involving the upper third of the femur of the Acetabular
4. Ankylosing spondylitis
5. Psoriatic arthritis
6. Old osteomyelitis -- with a long infection-free period and a normal WBC. ESR and C-reactive protein
7. Non-union of femoral neck fracture or avascular necrosis of the femoral head
8. Post-traumatic fracture/dislocation of the hip
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
11. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.
    These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem.

The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem. Manufactured by CeramTec AG, the Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474, with a small amount of magnesium to prevent grain growth. The Ceramic Ball Heads are available in various sizes from 28, 32 up to 36 mm, in small medium and large for each.

This is a 510(k) premarket notification for a medical device (Ceramic Ball Heads), not an AI/ML device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training set" are not applicable in the context of AI/ML device evaluation.

The provided document describes a traditional medical device submission seeking substantial equivalence to a predicate device. Here's how the relevant information from the document addresses your request, interpreted for a non-AI/ML device:

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

For non-AI/ML devices submitted via 510(k), "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of indications for use, technological characteristics, and performance testing, often against recognized standards.

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 applicable. This is a submission for a non-AI/ML medical device, and the "test set" concept in the context of data used to evaluate AI performance does not apply here. The evaluation relies on design control documentation, compliance with established standards, and bench testing, not on human-read data sets.

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. "Ground truth" in the context of human expert adjudication for AI model evaluation is not relevant for this traditional medical device submission. The "truth" is established by adherence to engineering specifications, material science, and performance testing against recognized standards.

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

This information is not applicable. Adjudication methods are specific to AI/ML device evaluation where human experts resolve discrepancies in ground truth labeling. This concept does not apply to the safety and performance evaluation of a ceramic hip ball head.

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. MRMC studies are used to evaluate the impact of AI on human reader performance, which is entirely outside the scope of evaluating a physical hip implant component.

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

This information is not applicable. There is no algorithm or AI component in this device.

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

For this type of device, what could be considered "ground truth" relates to:

• Material specifications: Conforming to the requirements of ISO 6474:1994 for high purity alumina.
• Mechanical performance: Meeting the test criteria established in ISO 7206-10, 2003 for hip-joint prostheses (bench testing).
• Sterilization efficacy: Adherence to AAMI / ANSI / ISO 11137:1994 for radiation sterilization.
• Design intent: Verification and validation carried out according to FDA's Design Control Requirements (21 CFR Part 820.30) to ensure the device performs as intended and is safe.

8. The sample size for the training set

This information is not applicable. There is no AI/ML model, and therefore no "training set."

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

This information is not applicable as there is no training set for an AI/ML model.

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The PiGalileo™ Total Hip Replacement (THR) System is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. hip center, pelvic plane etc.).

Examples of some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty

The PiGalileo™ Total Hip Replacement (THR) software application when provided with the PiGalileo™ system cart results in the PiGalileo™ THR System, a softwarecontrolled electromechanical stereotaxic device for computer-aided navigation of PiGalileo™ surgical instruments with the purpose of assisting the surgeon in optimally positioning hip prostheses. Refer to Section 11.0 for an in depth description of the PiGalileo™ THR System.

The PiGalileo™ THR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively.

The PiGalileo™ THR System is based on common stereotaxic technology in which Infrared (IF) LED (light emitting diodes) or passive markers on the surgical instruments allow the instruments to be tracked in real time in the surgical field.

In the case of PiGalileo™ THR System, patient data that is required to navigate the surgical instruments is collected during the procedure. The system utilizes this data to establish a connection between passive locaters, i.e., Infrared (IF) light, and the system's IF camera as previously described tracks the surgical instruments in real time in the surgical field.

The precision of navigation-assisted surgery depends on accurate scanning of skeletal landmarks. Scanned morphological data represents the basis for calculating the position of the hip cup and hip stem. Scanned points must represent unique anatomic landmarks so that they can be located in a safe and reproducible manner throughout surgery. For cup navigation, the spinae, left/ right are scanned as well as the symphysis. Each point is scanned three times to enhance precision and used for inclination and anteversion alignment. For stem navigation, the sagital plane is determined from the tibialis anterior and the intersection point on the femur. The position and alignment of the proximal stem axis are determined with a probe which provides the basis of the varus/valgus alignment.

The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times. Risk mitigations implemented under Design Controls ensure that sufficient fail safe mechanisms allow the surgeon to convert to non-navigated conventional surgical techniques at any time.

The navigation platform for the PiGalileo™ THR System is the same as the navigation platform cleared under PiGalileo™ TKR System, K061362, and includes the following elements:

(a) System Cart housing the following items; there are no changes to the system cart as compared to K061362.
1 System electronics such as CPU and connection box
Monitor
User Interface consisting of keyboard, touch pad and hard controls, e.g., "ON / OFF", footswitch
Infrared (IF) Camera and Camera Stand/Tripod
Optional printer
System cabling
(b) PiGalileo™ THR Software refers to the PiGalileo™ System Software and the THR software application:
PiGalileo™ System Software: this software is the same as that of the PiGalileo™ TKR System; there are no changes to either the system software or the calculations or the landmark technique as compared to K061362.
PiGalileo™ THR software application consists of two applets, PiGalileo™ Hip Cup and PiGalileo™ Hip Stem. Each applet consists of a collection of software modules that support the surgeon in hip cup and hip stem replacement. Each module is designed specifically for an implant in which the software calculates the values provided on screen differently for each implant, the specific implant geometry and the implant specific instruments.
(c) Surgical Instruments: include universal instruments such as hemispheres, and various locators; navigated instruments are equipped with markers that are tracked by the stereotaxic camera.

The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.

The provided text describes the PiGalileo™ Total Hip Replacement (THR) System and its premarket notification (510(k)) to the FDA. However, the document does not contain specific acceptance criteria or a study detailing device performance against such criteria in terms of clinical accuracy or effectiveness.

Instead, the document focuses on:

• Device Description: What the PiGalileo™ THR System is and how it functions as a navigation system for hip replacement surgery.
• Intended Use/Indications for Use: The surgical procedures and assistance it provides.
• Predicate Device Comparison: How it compares to previously cleared navigation systems.
• Performance Standards (Regulatory Compliance): Conformance to various FDA-recognized standards for safety (electrical, mechanical, thermal), electromagnetic compatibility, software, sterilization, risk analysis, and biocompatibility of surgical tools.
• Design Control Performance Testing: A general statement about design verification and validation (bench testing) performed under FDA's Design Control Requirements.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, specific performance measures, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. The document does not provide this type of detailed performance study information.

Here's a summary of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of clinical accuracy (e.g., X mm accuracy for implant placement). The "acceptance criteria" here are largely met through adherence to recognized regulatory and design control standards.
• Reported Device Performance: No specific clinical or quantitative performance metrics (e.g., accuracy in degrees or millimeters, success rates, complication rates) are reported in this summary.

2. Sample size used for the test set and the data provenance: Not mentioned. The document refers to "bench testing" for design verification and validation, but no details on sample size, type of data, or provenance are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Given the nature of the device (a surgical navigation system) and the timeframe (2007), the 'ground truth' for bench testing would likely involve highly precise measurements by engineers or technical experts rather than clinical experts establishing a ground truth in diagnostic interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 mentioned. This document is for a surgical navigation system, not a diagnostic AI tool, so an MRMC study in the context of "human readers" is not applicable. The device assists surgeons, but the document doesn't quantify improvement in surgeon performance with the device versus without.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated regarding specific numerical performance of the algorithm. The system is designed with human-in-the-loop (the surgeon) and explicitly states, "The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times." Standalone performance (algorithm only) would pertain to the accuracy of its tracking and calculation systems, which is generally covered under design verification/bench testing, but no specific metrics are given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a navigation system, ground truth during verification testing would likely involve highly accurate physical measurements of instrument position and spatial relationships in a controlled environment, possibly using precision measurement tools.

8. The sample size for the training set: Not mentioned. The system is a rule-based or model-based navigation system, not a machine learning/AI diagnostic system trained on large datasets in the modern sense. It relies on mathematical algorithms and optical tracking.

9. How the ground truth for the training set was established: Not applicable in the context of modern machine learning training sets. The "ground truth" for the device's development would be engineering specifications and anatomical models used to program its navigational calculations.

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The POLARCUP® Dual Mobility System is indicated for:

• All forms of osteoarthritis .
• Dislocation risks .
• Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
• . Femoral head necrosis
• Proximal femoral fractures (especially femoral neck) .
• . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement

The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.

Shell Component: The POLARCUP® shell, is manufactured from stainless steel INOX M30NW according to ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel, and is available in three configurations:

• Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, with pegs and two flanges, uncemented use: allows for implantation with no pegs and no flanges, with no pegs and contoured flanges, screws in flanges but with no pegs, and two impacted pegs and two screws in flanges
• . Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, without pegs and flanges, uncemented use)
• . Stainless steel, mirror polished, without pegs and flanges, cemented use

Note: the pure Titanium coating found in the uncemented versions is a Titanium alloy according to ISO 5832-2:1999. Implants for Surgery -Metallic Materials - Part 2: Unalloyed Titanium.

The POLARCUP® shell is available in 13 sizes for each of the titaniumcoated versions for uncemented use, ranging in diameter from 43 mm to 67 mm. The mirror-polished version for cemented use is available in 11 sizes, ranging in diameter from 43 mm to 63 mm.

Cortical Screws and Impacted Pegs: Cortical screws and impacted pegs, both made of stainless steel INOX 316LVM according to ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel, are available for use with the POLARCUP® shell version with pegs and flanges for uncemented use. The cortical screws are 4.5 mm in diameter and available in 6 different lengths ranging from 40 mm to 60 mm. The impacted pegs are available in a single length of 13 mm.

Liner Component: The POLARCUP® liner component is a polyethylene insert, specifically Ultra-High Molecular Weight Polyethylene (UHMW PE) according to ISO 5834-2:1998, Implants for Surgery -- Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms, that retains the femoral head and moves freely in the POLARCUP® shell, allowing increased mobility and stability. The liner component is available in two internal joint diameters. 22 mm and 28 mm. The 22 mm diameter liner is available in 13 different sizes of spherical external radius of curvature whereas the 28 mm diameter liner is available in 11 different sizes of spherical external radius of curvature (to ensure a minimal thickness of 6.5 mm according to EN 12563).

The POLARCUP® Dual Mobility System may be used with the following components provided that they are legally marketed in the US and meet these specifications:

• Ball Heads: made of CoCrMo, ceramic or stainless steel, with diameters . of 22 or 28 mm
• Femoral Stems: polished or electro-polished necks .

This looks like a submission for a medical device (POLARCUP® Dual Mobility System) to the FDA, seeking 510(k) clearance based on substantial equivalence to a predicate device. The document primarily describes the device, its components, materials, intended use, and a comparison to a predicate device. It also lists performance standards and testing performed in accordance with FDA design control requirements.

However, the provided text does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic or AI-driven performance metrics.

Here's why and what's missing:

• This is a mechanical implant: The POLARCUP® Dual Mobility System is a hip joint prosthesis, a mechanical device. Its performance is evaluated through material science tests, biocompatibility, and mechanical integrity, not typically through diagnostic accuracy metrics like sensitivity, specificity, or reader studies common for AI or diagnostic imaging devices.
• "Acceptance criteria" here refer to regulatory compliance and mechanical performance standards, not diagnostic performance: The document implicitly states its acceptance criteria through its adherence to ISO standards for materials and sterilization, and compliance with FDA's Design Control Requirements (Title 21 Code of Federal Regulations, Part 820.30). These ensure the device is safe and effective for its mechanical and biological function as an implant.
• No "study that proves the device meets acceptance criteria" in the requested format: The document mentions "Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements." This is the general statement about how its performance was verified, but it doesn't detail specific acceptance criteria values (e.g., "X% accuracy," "Y mm deviation") or the results of those specific tests in a table, as would be expected for a diagnostic device.
• Missing all AI/diagnostic specific questions: Because this is a mechanical implant, there's no information about sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or type of ground truth (e.g., pathology, outcomes data). These are relevant for AI/diagnostic devices, not for an orthopedic implant.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving performance in the context requested. The document does not provide the type of information that aligns with those questions.

To illustrate the type of information this document does provide, here's a summary of its performance-related content:

Summary of Performance-Related Information from the Provided Text:

• Materials: Conformance to ISO 5832-9:1992 (Stainless Steel INOX M30NW), ISO 5832-2:1999 (Unalloyed Titanium), ISO 5832-1:1997 (Stainless Steel INOX 316LVM), ISO 5834-2:1998 (UHMW PE).
• Design and Manufacturing: Compliance with FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
• Mechanical Integrity: Not explicitly quantified in this summary, but implied by "Design verification and design validation, e.g., bench testing." (Specific thresholds and results for wear, fatigue, etc., would be in the full submission). |
  | Reported Device Performance | - "Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements."
• The document concludes that the device is "substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics." This implies that its performance (mechanical, material, etc.) is comparable and acceptable given its design and predicate. |

Answers to Specific Questions (Based on Lack of Relevant Information):

1. A table of acceptance criteria and the reported device performance: See table above, but note that the specific numerical acceptance criteria and corresponding numerical performance results for mechanical properties are not detailed in this summary.
2. Sample sized used for the test set and the data provenance: Not applicable/Provided. The tests are bench tests on device components/assemblies, not observational data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert review.
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 is not an AI/diagnostic 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 (expert concensus, pathology, outcomes data, etc): Not applicable. Ground truth for material and mechanical tests is based on established engineering principles and measurement standards.
8. The sample size for the training set: Not applicable. This device does not use a "training set" in the AI sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (a hip implant), and thus the questions pertinent to AI or diagnostic device performance evaluation cannot be answered from this text.

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The PROMOS Modular Shoulder System is indicated for:

• Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or inflammatory arthritis
• Avascular necrosis of the humeral head
• Complex fractures of the proximal humerus
• Functional impairment especially in the case of post-traumatic loss of the joint configuration
  The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.

The modified PROMOS® Modular Shoulder System is intended to aid in the restoration of shoulder motion and elimination of pain. This device consists of two primary components, the glenoid component and the modular humeral component. The changes to the PROMOS® Shoulder that resulted in the modified PROMOS® Shoulder and are subject of this 510(k) include:

• Addition of size 3.5 humeral stem, cementless .
• Addition of six humeral ball heads R21 R26, with 4 mm eccentricity .
• Redesign of body and inclination set to add face gear to area between . inclination set and body
• Addition of three Monoblock stems, cementless, size 02/30, 35 and 40 mm .
• Various labeling changes .
  The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe) according to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
  The modular humeral component consists of a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross-sectional shape, previously available in seven cemented and seven cementless sizes, and now available in seven cemented and eight cementless sizes. It is attached to the body via a Morse type taper.
  The cementless and cemented stems are fabricated from titanium alloy (Ti6Al4V) according to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
  The body is made of same titanium alloy as the distal stems and is available in three sizes. The body and inclination set have been redesigned to add a face gear to the area between the inclination set and body. As before the modified inclination set consists of three components: an inclination insert, an offset module, and a ball head screw.
  The modular humeral heads are manufactured from wrought cobalt-chromiummolybdenum (CoCrMo) alloy according to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy, previously available in eight different sizes/eccentricities, and now available in 14 different sizes/eccentricities.
  Since cementless or cemented stems in size 01 may be too large for some patients, the company has developed a humeral stem, size 02. The narrow crosssection of a size 02 stem precluded a modular design, i.e., 02 size stem and a selection of bodies. As a result, the company implemented the size 02 as a Monoblock system with three different heights for body sizes 30mm, 35mm, and 40mm. The design of the cross-section is the same as mentioned above in the description of the distal stem and the stem is made of the same titanium allov. The proximal portion has also been redesigned to add face gear to the area between inclination set and body.

This document describes the 510(k) Premarket Notification for the PROMOS® Modular Shoulder System. The submission focuses on modifications to an existing device, K032126. It is a traditional 510(k) and primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards and design controls rather than extensive clinical studies or acceptance criteria defined in terms of device performance metrics like sensitivity/specificity.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI/software device, because it is a submission for a physical medical device (shoulder prosthesis). Instead, the acceptance criteria are related to compliance with established standards for materials, sterility, and design controls for mechanical devices.

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

This is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/software performance study. The data provenance refers to materials (e.g., titanium alloy, UHMWPe) and the design files, not a clinical dataset. The testing performed is bench testing (e.g., mechanical, material characterization), not a study on patient data.

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

This is not applicable. Ground truth, in the context of an AI/software device, refers to a definitive answer derived from expert review or a gold standard. For this physical device, "ground truth" relates to the specification of material properties and design requirements, which are established by engineering standards and internal design teams, not by medical experts reviewing a test set for diagnostic accuracy.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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

No. This is a physical orthopedic implant, not an imaging analysis or diagnostic AI device. An MRMC study is designed to assess the performance of human readers, with and without AI assistance, on a set of clinical cases. This type of study is not relevant to the evaluation of a shoulder prosthesis.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for demonstrating performance is based on:

• Engineering Standards: Compliance of materials (UHMWPe, Ti6Al4V, CoCrMo) with recognized ISO standards (e.g., ISO 5834-2, ISO 5832-3, ISO 5832-12).
• Sterilization Standards: Compliance with AAMI/ANSI/ISO 11137 for radiation sterilization.
• Design Controls: Verification and validation activities performed as per FDA's Design Control Requirements (21 CFR Part 820.30), which would involve testing against predefined engineering specifications and functional requirements.
• Predicate Device Comparison: Establishing substantial equivalence by comparing technical characteristics and indications for use to the legally marketed predicate device (K032126).

8. The Sample Size for the Training Set

This is not applicable. There is no AI/machine learning algorithm involved that would require a "training set."

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

This is not applicable for the reasons stated above.

In summary:

This 510(k) submission is for modifications to a physical orthopedic implant. The "acceptance criteria" and "studies" are focused on demonstrating manufacturing quality, material compatibility, and engineering performance through adherence to recognized standards and bench testing, rather than clinical performance metrics typically associated with AI or diagnostic devices. The core of the submission relies on establishing substantial equivalence to a previously cleared predicate device based on these engineering and material considerations.

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The PiGalileo™ TKR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc.).

Examples of some surgical procedures include but are not limited to:

• Total knee replacement supporting both bone referencing and ligament balancing techniques
• Minimally invasive total knee replacement

The PiGalileo™ Navigation (NAV) Total Knee Replacement (TKR) Computer Assisted Surgical (CAS) System (PiGalileo™ TKR System) is a softwarecontrolled electromechanical sterotaxic device for computer-aided navigation of PI Galileo surgical instruments with the purpose of assisting the surgeon in optimally positioning prostheses of the TC-PLUS and VKS knee systems.

The PiGalileo™ TKR System is based on common stereotaxic technology in which Infrared (IF) LED (light emitting diodes) or passive markers on the surgical instruments allow the instruments to be tracked in real time in the surgical field.

In the case of PiGalileo™ TKR System, patient data that is required to navigate the surgical instruments is collected during the procedure. The system utilizes this data to establish a connection between passive locaters, i.e., Infrared (IF) light, and the system's IF camera as previously described tracks the surgical instruments in real time in the surgical field.

Two passive locators are attached to the tibia and distal femur during surgery, where one locater is mobile to determine specific landmarks, known as Bone Referencing (BR) on the tibia and femur. Once the system has collected the information, the system positions a motorized cutting guide on the femur to support the surgeon during surgery and provides information to position or "navigate" additional instruments.

The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times. Positions of the motorized cutting guide may also be adjusted manually. Risk mitigations were implemented under Design Controls to ensure that sufficient fail safe mechanisms allow the surgeon to convert to non-navigated conventional surgical techniques at any time.

The PiGalileo™ TKR System consists of three main elements:

• System Cart which houses:
  • System electronics and cabling
  • Monitor
  • User Interface
  • IF Camera and Camera Stand
  • Optional printer
• Software:
  • PiGalileo System Software
  • Application Software
    • a) PiGalileo TKR BR
    • b) PiGalileo TKR Ligament Balancing (LB)
    • c) PiGalileo TKR Light
    • d) PiGalileo TKR Minimally Invasive Surgery (MIS)
• Standard Surgical Instruments and application-specific surgical instruments

The provided document for K061362, concerning the PiGalileo™ Total Knee Replacement (TKR) System, does not include specific acceptance criteria or an explicit study proving the device meets performance criteria in the format requested. The submission focuses on substantial equivalence to predicate devices and adherence to recognized standards for safety and software.

Here's a breakdown of the available information based on your request, with "Not applicable" or "Not specified" where the document does not provide the information:

1. Table of acceptance criteria and the reported device performance

Explanation: The document does not define explicit acceptance criteria in terms of accuracy, precision, or other performance metrics for the PiGalileo™ TKR System itself. Instead, it refers to conformity with general standards for electromagnetic compatibility, thermal/electrical/mechanical safety, and software.

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

The document states: "Neither bench, animal nor clinical testing were assessed." This implies that no specific test set of cases (patients or cadavers) was used for performance evaluation to demonstrate substantial equivalence, as the focus was on comparing technical characteristics and indications for use. Therefore, sample size and data provenance are Not applicable for this type of submission.

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

Not applicable. As no specific performance testing was assessed for substantial equivalence, there was no test set requiring ground truth establishment by experts.

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. The PiGalileo™ TKR System is a computer-assisted surgical navigation system, not an AI-driven diagnostic or interpretative tool that would involve human "readers" in the context of an MRMC study.

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

The document mentions "Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements," which is a general statement. However, it explicitly states "Neither bench, animal nor clinical testing were assessed" in the context of the substantial equivalence comparison. Therefore, specific standalone performance data was not provided or assessed in this 510(k) summary. The device's nature as a surgical assistance system inherently involves "human-in-the-loop" at all times as the surgeon maintains control.

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

Not applicable. No specific ground truth was established for performance testing as it was not assessed as part of the substantial equivalence submission.

8. The sample size for the training set

The document states "Neither bench, animal nor clinical testing were assessed." and refers to "Design Control documentation". While the system utilizes patient data collected intra-operatively, this refers to data used during the procedure for real-time navigation, not a "training set" in the machine learning sense to develop the algorithm. Therefore, "training set" sample size is Not applicable in the context of this submission.

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

Not applicable.

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