(275 days)
Mendec Spine is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, bening lesions (hemangioma), and malignant lesions (metastatic cancers, mylema)
Like the predicate devices. Mendec Spine acrylic resin is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabiliser and N.N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
The provided text is a 510(k) summary for a bone cement device called "Mendec Spine." It details the device's substantial equivalence to predicate devices based on chemical composition and mechanical testing. However, it does not describe any acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostics or AI algorithm performance.
The document is for a traditional 510(k) submission for a medical device (bone cement), not an AI/ML powered device. The "acceptance criteria" and related study questions in your prompt are typically relevant for AI/ML devices, where performance metrics like sensitivity, specificity, or AUC are evaluated against pre-defined thresholds.
Since this is for a traditional bone cement, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through comparison of chemical composition and mechanical testing according to established standards.
Here's how to address your numbered points based on the provided text, modified to fit the context of a traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
For this bone cement, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices, particularly regarding chemical composition and mechanical properties. The reported device performance is presented as direct comparison data.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (Mendec Spine) |
|---|---|
| Chemical Composition: Proportionality to predicate Kyphx HV-R (#K033801, #K041584) and Spineplex (#K032945) | Powder: Polymethymethacrylate (67.50% w/w), Barium sulphate (30.0% w/w), Benzoyl peroxide (2.5% w/w) – Compared directly to predicates, e.g., Kyphx HV-R powder is 68.0% PMMA, 30.0% BaSO4, 2.0% Benzoyl peroxide. |
| Liquid: Methylmethacrylate (monomer) (99.1% w/w), N.N-dimethyl-p-toluidine (0.90% w/w), Hydroquinone (75 ppm) – Compared directly to predicates, e.g., Kyphx HV-R liquid is 99.1% MMA, 0.90% N.N-dimethyl-p-toluidine, 75 ppm Hydroquinone. | |
| Mechanical Test Performance: Substantially equivalent to predicate device, as defined by ISO 5833:2002, "Implants for Surgery - Acrylic resin cements." | "Mechanical tests: Mendec Spine acrylic resin was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, 'Implants for Sugery - Acrylic resin cements'" |
| Biocompatibility: Compliance with ASTM F 451-99 point 10 and ISO 10993. | "The materials used in Mendec Spine complies with ASTM F 451-99 point 10 and ISO 10993" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for chemical composition analysis or mechanical testing. It states "Mendec Spine acrylic resin was tested in direct comparison to the predicate device." Given the nature of a 510(k) for bone cement, the "test set" would typically refer to batches of the material used for testing, but specific numbers are not provided. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the specific test data, beyond the manufacturer being Italian (TECRES S.p.A, Verona, Italia).
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 question is not applicable to this submission. "Ground truth" in the context of expert review is primarily relevant for diagnostic AI/ML devices where human interpretation is being benchmarked or assisted. For a bone cement, the "ground truth" is established by adherence to chemical formulations, physical properties measured in a lab, and compliance with recognized standards (ISO, ASTM). Human experts would be involved in protocol design, execution, and interpretation of these laboratory tests, not in establishing a medical "ground truth" based on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in diagnostic imaging or clinical assessments, which is not the subject of this 510(k).
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/ML diagnostic or assistive device. MRMC studies are used to evaluate the performance of human readers, with or without AI assistance, on sets of cases, which is not relevant for bone cement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Chemical Analysis: Verifying the exact composition of the powder and liquid components against the stated formulation and in comparison to predicate devices.
- Mechanical Testing: Objective measurements of physical properties (e.g., tensile strength, compressive strength, fatigue life) under controlled laboratory conditions, as defined and specified by recognized international standards (ISO 5833:2002).
- Biocompatibility Testing: Compliance with established standards (ASTM F 451-99 and ISO 10993) to demonstrate the material's safety in biological systems.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”