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Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

The cement restrictor is a single, molded component intended to be used for blocking the diaphysis of the femoral canal. It is positioned a few centimeters distal to the distal tip of the prosthesis stem or the stem's centralizer to prevent migration of bone cement beyond the proximal zone of the femoral medullary canal. The cement restrictor is positioned with the aid of an insertion instrument. The restrictors are manufactured of radiolucent medical grade Ultra-High Molecular-Weight Polyethylene (UHMWPE) per ASTM standard F648-00, and ISO standards ISO 5834-1:1998 and ISO 5834-2:1998. They are manufactured in two sizes: "Small" and "Large." The small restrictors are to be used for femoral medullary canals ranging from 12 to 18 mm. The large restrictors are to be used for femoral medullary canals ranging from 18 to 24 mm.

The provided document does not contain information about a study proving the device meets acceptance criteria in the way typically structured for a medical device that uses an algorithm or AI.

This document is a 510(k) summary for a physical medical device, the Tecres Cement Restrictor. The 510(k) process for such devices primarily focuses on demonstrating substantial equivalence to a previously legally marketed device, not on meeting specific quantitative performance metrics through a clinical or algorithmic performance study with acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of submission as presented in the provided text.

Here's a breakdown of what can be gleaned from the document based on the request:

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

• Not Applicable. This document is a 510(k) summary for a physical medical device, the Tecres Cement Restrictor, demonstrating substantial equivalence to predicate devices. It does not contain performance acceptance criteria in the context of an algorithm or AI, nor does it report specific numerical performance metrics from a study to meet such criteria. The "performance" is implicitly deemed equivalent to the predicate devices.

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

• Not Applicable. No test set or data provenance is mentioned as this is not an AI/algorithm-based device and no such study is detailed.

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 definition by experts is not relevant to this submission for a physical device.

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

• Not Applicable. No test set or adjudication method is 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 Applicable. This is not an AI-assisted device, so no MRMC study improving human readers with AI assistance would be conducted.

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

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

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

• Not Applicable. Ground truth, in the context of an AI/algorithm performance study, is not relevant to this submission for a physical device.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this concerns a physical medical device, not an algorithm.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document does provide regarding "acceptance" or clearance:

The document describes the device description, intended use, indications, and contraindications. The "acceptance" in this context refers to clearance via the 510(k) pathway by demonstrating substantial equivalence to legally marketed predicate devices.

The FDA reviewed the submission and determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This is the primary "acceptance criterion" for a 510(k) submission for a non-novel physical device.

The study that "proves" the device meets acceptance criteria in this specific context is the 510(k) submission itself, which articulates how the device is equivalent to existing cleared devices through:

• Similar intended use: Blockage of the femoral medullary canal (Page 2).
• Similar technological characteristics: Manufactured from UHMWPE, similar sizes (Small for 12-18mm canals, Large for 18-24mm canals) (Page 2).
• Performance: While not explicitly detailed with quantitative data in this summary, the implication is that its mechanical and biological performance is comparable to the predicate devices made of similar materials and functions structurally the same way. The sterilisation method (gamma ray irradiation) is also specified to a SAL of 10-6 (Page 3).

The FDA's letter (Page 4-5) confirms the finding of substantial equivalence based on the provided information in the 510(k) premarket notification.

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The CEMENT RESTRICTOR (CR) is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.

The CEMENT RESTRICTOR (CR) is NOT intended for any spinal indications.

The subject CEMENT RESTRICTOR is a tapered block that is made from POLYETHERETHERKETONE (PEEK). The device is intended to be used in conjunction with standard PMMA cement.

Implants are manufactured out of medical-grade titanium alloy such as described by ASTM F136 or ISO 5832-3. The CEMENT RESTRICTOR implants may also be manufactured from 70:30 Polylactic Acid (Poly (L-lactide-co-D, L -lactide) 70:30, amorphous). Alternatively, the entire system may be made out of POLYETHERETHERKETONE (PEEK) as described by standards such as ASTM F-2026.

The provided document is a 510(k) summary and FDA clearance letter for a medical device called the "CEMENT RESTRICTOR (CR)". It describes the device, its intended use, and its substantial equivalence to previously cleared devices. Crucially, this document is a regulatory submission for a physical medical device (an implantable cement restrictor), not an AI/ML powered device.

Therefore, most of the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance does not apply to this type of submission. The FDA clearance for this device hinges on its substantial equivalence to predicate devices, focusing on materials, design, and intended use, rather than a performance study of an algorithm.

Here's a breakdown of why the requested information isn't present in the provided text:

• No AI/ML Component: The device is a physical "tapered block" made of specific materials (PEEK, titanium alloy, polylactic acid). It does not involve any software, algorithms, or AI/ML for diagnosis, prognosis, or treatment.
• Substantial Equivalence Pathway: The clearance is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices (K013014 and K010528). This typically involves comparing design, materials, manufacturing processes, and intended use, rather than extensive performance studies in the way an AI/ML device would require.
• Focus on Material and Intended Use: The "purpose of this submission is to obtain clearance for the alternative material." This indicates the primary focus was on the safety and compatibility of the new material, not the performance of a diagnostic or predictive algorithm.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study data for an AI/ML device because the provided document does not pertain to such a device.

If you have a document related to an AI/ML powered device, I would be happy to analyze it for the requested information.

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