(24 days)
The Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals when used with an appropriately indicated endoscope.
Additionally, when used in conjunction with a Smith & Nephew light source and light cable the Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
The Smith & Nephew HD Camera System is used in endoscopic surgical procedures to capture and transmit video images. The Smith & Nephew HD Camera System consists of a camera control unit and a camera head. The camera system has been designed to be capable of outputting a true high definition picture. The high definition picture is maintained by continuous transmission of high resolution ourput from the camera head to the camera control unit.
Here's an analysis of the provided text regarding the Smith & Nephew HD Camera System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K070266) is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific quantifiable acceptance criteria and their direct performance results.
However, based on the text, the implicit acceptance criteria are that the device performs as well as the legally marketed predicate device and that any differences do not raise new issues of safety and efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Conformance to relevant electrical safety standards. | The Smith & Nephew HD Camera System conforms to: |
- IEC 60601-1 (1998) + Amendment 1 (1991) + Amendment 2 (1995) (UL 2601-1)
- IEC 60601-1-1 (1992) + Amendment 1 (1995), (2000)
- UL 60601-1 (2003)
- CAN/CSA 22.2 No. 601.1 (1990) |
| Electromagnetic Compatibility (EMC): Conformance to relevant EMC standards. | The Smith & Nephew HD Camera System conforms to: - IEC 60601-1-2 (2001-09) 2nd Edition |
| Efficacy/Performance: Capability to capture and transmit video images for endoscopic surgical procedures. | The performance testing, EMDEMC testing, UL Safety testing, and software verification and validation demonstrate substantial equivalence to the DYONICS Vision 325Z DV 3-CCD Hermes-Ready Camera System (K031379). |
| No New Safety/Efficacy Issues: Any differences from the predicate device do not introduce new risks. | "The testing also demonstrates that any differences in the new device and the predicate device do not raise any new issues of safety and efficacy..." |
| Substantial Equivalence: Similar in intended use, operating principle, basic design, and technology. | "The Smith & Nephew HD Camera System similarities to the predicate device are: - has the same Indications for Use
- utilizes the same operating principle
- incorporates the same basic design
- incorporates the same technological characteristics as the predicate" |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set. This type of submission (510(k)) primarily demonstrates equivalence to a predicate device through engineering tests, rather than clinical efficacy studies with patient data. The "performance testing" mentioned refers to engineering and validation tests rather than clinical trials with patient samples. Therefore, there's no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. As noted above, the validation relies on engineering and regulatory compliance testing, not a clinical study requiring expert-established ground truth from medical images/data.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. No clinical test set requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a camera system simply providing visualization.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The "performance testing" mentioned in the summary is, by definition, a standalone evaluation of the device's technical capabilities (e.g., image quality, electrical safety, EMC). This is not an algorithm performance study as would be typical for an AI/ML device, but rather a functional and safety evaluation of the hardware system itself. The camera system provides an image; it doesn't process data with an algorithm to make a diagnostic assessment.
7. The Type of Ground Truth Used:
For the engineering and regulatory compliance testing, the "ground truth" would be established by technical specifications, industry standards, and validated test methodologies. For example:
- Electrical safety: Measured electrical parameters must fall within specified ranges defined by standards like IEC 60601-1.
- EMC: Emissions and immunity must meet the limits defined by IEC 60601-1-2.
- Image output: The system's output would be compared against a high-definition standard to confirm it meets "true high definition."
There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as this is a hardware device for visualization, not a diagnostic interpretive tool.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable. The Smith & Nephew HD Camera System is a hardware device; it does not involve machine learning algorithms that require a "training set" of data. Its design and manufacturing follow established engineering principles and a Quality System.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and not applicable, for the same reasons as #8.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.